[ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-04870", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211119", "model_number": "10601", "catalog_number": "10601", "lot_number": "0024854780", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200706", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840039", "udi_public": "08714729840039", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/28/2020", "manufacturer_contact_country": "", "date_changed": "20230725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200819", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000690", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189033874", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: USED (B)(6) 2020 AS THE CORRECT DATE WAS NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "189033875", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "319686272", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3 - DATE OF EVENT: USED (B)(6) 2020 AS THE CORRECT DATE WAS NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.50 X 12 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKER BANDS. THE CRIMPED STENT OD (OUTER DIAMETER) WAS MEASURED USING AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS AND A BREAK 23.5CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319686273", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/19/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03961", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20150204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230626", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10006104", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189214077", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF DEATH, MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIALNA." }, { "mdr_text_key": "189214078", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCATION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X20MM BALLOON AT 10 ATMOSPHERES (ATMS), AND THE 3.5X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X15MM BALLOON AT 12 ATMS. THE PATIENT DEVELOPED THROMBOSIS, MI, AND SUBSEQUENTLY DIED 430 DAYS LATER. TYPE OF TREATMENT, IF ANY, WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "315104135", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03964", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140311", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230526", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10006287", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189215831", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF DEATH, MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED." }, { "mdr_text_key": "189215832", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X15MM BALLOON AT 12 ATMOSPHERES (ATMS), AND THE 3.5X12MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X8MM BALLOON AT 22 ATMS. THE PATIENT DEVELOPED THROMBOSIS, MI, AND SUBSEQUENTLY DIED 100 DAYS LATER. TYPE OF TREATMENT, IF ANY, WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "314986630", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-05011", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200429", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200429", "manufacturer_contact_f_name": "JAY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200429", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Activation Failure" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200429", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Perforation" ] } ], "distributor_city": "", "date_report": "20200429", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10010755", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189695845", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT:USED THE FIRST DAY OF THE MONTH OF THE BSC AWARE DATE. EVENT DATE NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "189695846", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT MAL APPOSITION AND PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A ROTABLATOR WAS USED IN THE PROXIMAL LAD AND A 3.0 SYNERGY II DRUG-ELUTING STENT WAS IMPLANTED IN THE PROXIMAL TO MID LAD. HOWEVER, THE MID TO DISTAL AREA WHERE THE ROTA WAS PERFORMED HAD RECOILED AND ANGIOGRAPHIC DISTORTION OF THE STENT WAS NOTED. A 3.0 NC BALLOON CATHETER WAS ADVANCED FOR POST-DILATATION BUT THE STENT WOULD RECOIL UPON DEFLATION OF THE BALLOON. ATMOSPHERIC PRESSURE WAS INCREASED TO RATED, HOWEVER, PERFORATION OCCURRED. A PERICARDIOCENTESIS WAS PERFORMED AND THE BALLOON WAS INFLATED FOR A LONG PERIOD OF TIME. THE PATIENT STABILIZED AND NO FURTHER PERFORATION WAS NOTED. THE PATIENT WAS DISCHARGED WITHOUT ANY ADDITIONAL ISSUES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-05910", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200501", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200408", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200501", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190715", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200501", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210714", "model_number": "10605", "catalog_number": "10605", "lot_number": "0024147797", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840282", "udi_public": "08714729840282", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200501", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200501", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10017488", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189754654", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "189754655", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT FAILED TO CROSS THE LESION AND THE RAILING BROKE. THE PHYSICIAN ATTEMPTED TO CROSS THE SECOND STENT, A 2.50 X 12 SYNERGY DRUG-ELUTING STENT; HOWEVER, THE PHYSICIAN STOPPED THE PROCEDURE WHEN HE NOTICED THAT THE RAILING WAS GOING TO BREAK AGAIN. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-05181", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200501", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200405", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200501", "manufacturer_contact_f_name": "JAY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200501", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "10601", "catalog_number": "10601", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated", "Migration" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200501", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200501", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10017577", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC IRELAND LIMITED", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189834791", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "189834792", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DISLODGEMENT AND MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND HIGHLY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATION OF A 2.0MM AND 2.5MM EMERGE BALLOON CATHETER, A 3.50 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. A NON-BSC GUIDE EXTENSION CATHETER WAS INSERTED TO RE-DELIVER THE DEVICE, HOWEVER, RESISTANCE WAS FELT WHILE ENTERING THE STENT AND STILL WAS NOT ABLE TO CROSS THE LESION. THE DEVICE WAS PULLED INTO THE GUIDE BUT THE STENT WAS DISLODGED ON THE TIP OF THE GUIDE CATHETER. THE GUIDE CATHETER WAS REMOVED WHEN THE STENT MIGRATED FURTHER INTO A VESSEL IN THE PATIENT'S LEG. THE PHYSICIAN'S RECOMMENDATION WAS MADE TO LEAVE THE STENT DUE TO NO SUBSEQUENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH SURGERY AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A BYPASS PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-05954", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200501", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200424", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200501", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190930", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200501", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210929", "model_number": "10605", "catalog_number": "10605", "lot_number": "0024588027", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840305", "udi_public": "08714729840305", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200501", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200501", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10019429", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200428", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190015345", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "190015346", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT \"LOOK DIFFERENT\". THE DEVICE WAS REMOVED AND THE STRUTS WERE FOUND UNRAVELING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-05187", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200506", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200409", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200506", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190715", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200506", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210714", "model_number": "10602", "catalog_number": "10602", "lot_number": "0024132636", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840114", "udi_public": "08714729840114", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Failure to Advance" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200506", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Vascular Dissection" ] } ], "distributor_city": "", "date_report": "20200506", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10029567", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200410", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190111376", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "190111377", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT FAILED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT STRIPPED AN ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-06153", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200507", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200507", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190912", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200507", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210911", "model_number": "10604", "catalog_number": "10604", "lot_number": "0024466198", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840237", "udi_public": "08714729840237", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200507", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200507", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10032377", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200413", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190680098", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "190680099", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DISLODGEMENT WAS ENCOUNTERED. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED UNDEPLOYED, HOWEVER, THE STENT CAME OFF THE BALLOON AND IT WAS FOUND ON THE STERILE FIELD. NO FURTHER INFORMATION AVAILABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-06341", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200512", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200424", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200512", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200512", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211110", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024825236", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200605", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840176", "udi_public": "08714729840176", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/02/2020", "manufacturer_contact_country": "", "date_changed": "20230726", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200512", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200714", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10048428", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200424", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191011620", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "191011621", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT A STENT STRUT STUCK OUT AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." }, { "mdr_text_key": "319779756", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 3.00 X 20MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS FROM THE PROXIMAL END OF THE STENT WERE LIFTED AND PULLED DISTALLY. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND A KINK 60MM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319779757", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT A STENT STRUT STUCK OUT AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/14/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2134265-2020-06391", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200513", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200513", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200513", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/18/2020", "manufacturer_contact_country": "", "date_changed": "20230601", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200513", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "Vascular Dissection" ] } ], "distributor_city": "", "date_report": "20200609", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10051626", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200416", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190770369", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT IS UNKNOWN. BSC BECAME AWARE OF THE EVENT ON (B)(6) 2020. THEREFORE A DATE OF (B)(6) 2020 WAS ENTERED TO INDICATE THAT THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) 2020. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "190770370", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT PER SOCIAL MEDIA A DISSECTION OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, A ROTAPRO WITH 1.25 BURR WAS UNABLE TO CROSS THE TARGET LESION. IT WAS NOTED THAT THERE WAS NO DECREASE OF RPM DESPITE REACHING 240,00 RPM. A NEW ATTEMPT WITH A ROTAPRO WITH A 1.5 BURR (180,000RPM) WAS ABLE TO CROSS THE LESION. AFTER ROTABLATION, A WOLVERINE CUTTING BALLOON WAS ADVANCED TO DILATE THE TARGET LESION. A SYNERGY MEGATRON STENT AND A SYNERGY STENT WERE ADVANCED TO THE TARGET LESION AND A PROXIMAL DISSECTION WAS NOTED UP TO THE RIGHT CORONARY SINUS OF VALSALVA. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE DISSECTION WAS NOT A RESULT OF A BOSTON SCIENTIFIC PRODUCT. IT WAS NOTED THAT THE PHYSICIAN WAS VERY SATISFIED WITH THE OVERALL PERFORMANCE OF BOSTON SCIENTIFIC PRODUCTS IN THE CASE, PARTICULARLY THE MEGATRON. IT WAS NOTED THAT THE ISSUES WERE THE RESULT OF CASE COMPLEXITY. THE MEGATRON AND ALL OTHER BOSTON SCIENTIFIC PRODUCTS HELPED TO RESOLVE THE CASE POSITIVELY." }, { "mdr_text_key": "315952490", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PER SOCIAL MEDIA A DISSECTION OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, A ROTAPRO WITH 1.25 BURR WAS UNABLE TO CROSS THE TARGET LESION. IT WAS NOTED THAT THERE WAS NO DECREASE OF RPM DESPITE REACHING 240,00 RPM. A NEW ATTEMPT WITH A ROTAPRO WITH A 1.5 BURR (180,000RPM) WAS ABLE TO CROSS THE LESION. AFTER ROTABLATION, A WOLVERINE CUTTING BALLOON WAS ADVANCED TO DILATE THE TARGET LESION. A SYNERGY MEGATRON STENT AND A SYNERGY STENT WERE ADVANCED TO THE TARGET LESION AND A PROXIMAL DISSECTION WAS NOTED UP TO THE RIGHT CORONARY SINUS OF VALSALVA. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE DISSECTION WAS NOT A RESULT OF A BOSTON SCIENTIFIC PRODUCT. IT WAS NOTED THAT THE PHYSICIAN WAS VERY SATISFIED WITH THE OVERALL PERFORMANCE OF BOSTON SCIENTIFIC PRODUCTS IN THE CASE, PARTICULARLY THE MEGATRON. IT WAS NOTED THAT THE ISSUES WERE THE RESULT OF CASE COMPLEXITY. THE MEGATRON AND ALL OTHER BOSTON SCIENTIFIC PRODUCTS HELPED TO RESOLVE THE CASE POSITIVELY. IT WAS FURTHER REPORTED THAT THE DISSECTION WAS RELATED TO THE GUIDING CATHETER DUE TO PATIENT COMPLEXITY. IT WAS NOTED THAT THE DISSECTION OCCURRED BEFORE THE USE OF THE ROTA, AND BEFORE THE IMPLANT OF THE SYNERGY AND MEGATRON. THE SYNERGY AND THE MEGATRON WERE SUCCESSFULLY IMPLANTED WITHOUT NEGATIVE IMPACT. IT WAS FURTHER NOTED THAT THE OVERALL PERFORMANCE OF THE BSC PRODUCTS USED DURING THE PROCEDURE WAS POSITIVE. THE PATIENT WAS DISCHARGED TO HOME AND WAS REPORTED TO BE IN GOOD SHAPE." }, { "mdr_text_key": "315952491", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3: DATE OF EVENT: THE DATE OF EVENT IS UNKNOWN. BSC BECAME AWARE OF THE EVENT ON 16 (B)(6) 2020. THEREFORE A DATE OF (B)(6) 2020 WAS ENTERED TO INDICATE THAT THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) 2020. DEVICE IS A COMBINATION PRODUCT. MEDIA REVIEW ANALYSIS: THE FOUR TWITTER POSTS CONTAINED CLIPS OF ANGIOGRAPHIC MEDIA. THE MEDIA CLIPS WERE REVIEWED BY THE CIS INVESTIGATOR. THE FIRST POST SHOWED THE DISTAL END OF GUIDE CATHETER POSITIONED AT THE RIGHT CORONARY ARTERY (RCA) OSTIUM. CONTRAST FLOW RESTRICTION INDICATED LESIONS IN THE RCA. THE SECOND POST SHOWED ROTABLATION BEING CARRIED OUT IN THE RCA, AFTER DRILLING OF THE BURR IN MID RCA, THE BURR SUCCESSFUL ADVANCED THROUGH THE RCA. THE THIRD POST SHOWED BALLOON DILATION BEING CARRIED OUT IN THE MID RCA USING WOLVERINE CUTTING BALLOON. IN THE FOURTH POST DISSECTION OF THE RIGHT CORONARY SINUS WAS EVIDENT AND STENT(S) HAD BEEN DEPLOYED IN THE PROXIMAL RCA. THESE WERE MOST LIKELY THE SYNERGY II DES AND THE SYNERGY MEGATRON STENTS. A PACING LEAD WAS EVIDENT IN THE HEART. FLOW THROUGH THE RCA HAD BEEN IMPROVED COMPARED TO THE FIRST POST." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/09/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-05519", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200514", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200420", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200514", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191118", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200514", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211117", "model_number": "10606", "catalog_number": "10606", "lot_number": "0024833924", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840350", "udi_public": "08714729840350", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20200514", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10057935", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200420", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191004404", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "191004405", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE STENT CAME OFF THE BALLOON AND WAS RETRIEVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-06754", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200519", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200427", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200519", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20180723", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200519", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200722", "model_number": "10613", "catalog_number": "10613", "lot_number": "0022489376", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840794", "udi_public": "08714729840794", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200519", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200519", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10073339", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200513", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191688754", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "191688755", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT FAILED TO CROSS THE LESION. IT WAS ALSO NOTED THAT THE STENT WAS BENT ON THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-06041", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200520", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200422", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200520", "manufacturer_contact_f_name": "JAY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200520", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200520", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Perforation of Vessels" ] } ], "distributor_city": "", "date_report": "20200520", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10076897", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200424", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC IRELAND LIMITED", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191674012", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "191674013", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA ANTEGRADE APPROACH. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). SEVERAL SYNERGY STENTS WERE IMPLANTED AND POST-DILATATION WAS PERFORMED WITH A 5.0X12MM NC QUANTUM APEX BALLOON CATHETER. THE PHYSICIAN NOTICED A PERFORATION IN THE MID RCA. A NON-BSC STENT WAS USED TO COVER THE AREAS AND THE PROCEDURE WAS COMPLETED. ECHOCARDIOGRAM REVEALED TRACE OF BLOOD. THERE WERE NO CHANGES IN THE PATIENT VITAL SIGNS AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-05842", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200521", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200407", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200521", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200521", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211020", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024704250", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200519", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840169", "udi_public": "08714729840169", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/26/2020", "manufacturer_contact_country": "", "date_changed": "20230629", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200521", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200617", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10078587", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200427", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "317745955", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.75 X 20MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS IN BROKEN INTO 2 SECTIONS. AN EXAMINATION OF THE CRIMPED STENT IDENTIFIED PROXIMAL STENT DAMAGE, WITH PROXIMAL STENT STRUTS BUNCHED IN A DISTAL DIRECTION. THE UNDAMAGED CRIMPED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT IS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE IDENTIFIED A HYPOTUBE BREAK 235MM DISTAL FROM THE DISTAL END OF THE STRAIN RELIEF. MULTIPLE HYPOTUBE KINKS WERE ALSO NOTED. AN EXAMINATION OF THE SHAFT POLYMER EXTRUSION FOUND NO ISSUES. AN EXAMINATION OF THE TIP IDENTIFIED NO TIP DAMAGE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "317745956", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON PUSHING THE DEVICE THROUGH THE GUIDE, THE SHAFT BROKE 20 CENTIMETERS FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "191718174", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "191718175", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON PUSHING THE DEVICE THROUGH THE GUIDE, THE SHAFT BROKE 20 CENTIMETRES FROM THE HUB. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/17/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9612164-2020-01939", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200521", "manufacturer_address_2": "", "pma_pmn_number": "P160043", "date_of_event": "20200128", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200521", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200521", "brand_name": "RESOLUTE ONYX RX", "generic_name": "STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/22/2020;04/02/2021", "manufacturer_contact_country": "", "date_changed": "20230915", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200521", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "64 YR", "patient_sex": "", "patient_weight": "85", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombus", "Ventricular Fibrillation", "Injury", "Thrombosis/Thrombus", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20210409", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10078915", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200515", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "323533547", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE IS NO KNOWN RELATIONSHIP BETWEEN THE RESOLUTE ONYX AND THE DEATHS. HOWEVER, FOR 10 CASES THE CAUSE OF DEATH WAS UNKNOWN OR DOCUMENTED AS VENTRICULAR FIBRILLATION. THERE WAS 1 CASE OF VERY LATE STENT THROMBOSIS IN A RESOLUTE ONYX STENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "315958658", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: AVERAGE PATIENT WEIGHT PROVIDED IT WAS LATER REPORTED THAT THERE WERE 12 CARDIAC DEATHS IN THE PATIENT GROUP WITH RESOLUTE ONYX STENTS, OF WHICH NONE HAD DEFINITE STENT THROMBOSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "200397639", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE: AVERAGE AGE. SEX: MAJORITY GENDER. DATE OF EVENT: DATE OF PUBLICATION JOURNAL ARTICLE TITLE: THIN COMPOSITE-WIRE-STRUT ZOTAROLIMUS-ELUTING STENTS VERSUS ULTRATHIN-STRUT SIROLIMUS-ELUTING STENTS IN BIONYX AT 2 YEARS DOI.ORG/10.1016/J.JCIN.2020.01.230. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "200397640", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE AIM OF THIS BIONYX STUDY WAS TO ASSESS 2-YEAR SAFETY AND EFFICACY OF THE CURRENT-GENERATION THIN COMPOSITE-WIRE-STRUT DURABLE-POLYMER RESOLUTE ONYX ZOTAROLIMUS-ELUTING STENT (ZES), COMPARED WITH THE ULTRATHIN STRUT BIODEGRADABLE-POLYMER ORSIRO SIROLIMUS-ELUTING STENT (SES) IN ALL-COMERS AND A PRE-SPECIFIED SMALL-VESSEL SUBGROUP ANALYSIS. THE BIONYX STUDY IS AN INTERNATIONAL, PROSPECTIVE, INVESTIGATOR-INITIATED, PATIENT- AND ASSESSOR BLINDED, RANDOMIZED NON-INFERIORITY TRIAL. A TOTAL OF 2,488 ALL-COMER PATIENTS WERE TREATED AT 7 CORONARY INTERVENTION CENTERS IN BELGIUM, ISRAEL, AND THE NETHERLANDS FROM OCT OBER 2015 TO DECEMBER 2016. PATIENTS WERE RANDOMLY ASSIGNED (1:1) TO ZES OR SES, WHICH WERE AVAILABLE IN DIAMETERS RANGING FOR ZES FROM 2.0 TO 5.0 MM AND FOR SES FROM 2.25 TO 4.0 MM. FOLLOW-UP WAS AVAILABLE IN 2,460 OF 2,488 PATIENTS (98.9%). CLINICAL OUTCOMES INCLUDED ALL CAUSE DEATH, CARDIAC DEATH, TARGET VESSEL\u00bfRELATED MI, CLINICALLY INDICATED TARGET VESSEL REVASCULARIZATION AND STENT THROMBOSIS. THERE WERE NO SIGNIFICANT BETWEEN-STENT DIFFERENCES IN THE INCIDENCE OF THE INDIVIDUAL TVF (TARGET VESSEL FAILURE) COMPONENTS OF CARDIAC DEATH, TARGET VESSEL\u00bfRELATED MI, AND CLINICALLY INDICATED TARGET VESSEL REVASCULARIZATION. IN BOTH GROUPS, THE USE OF DUAL-ANTIPLATELET THERAPY AT 2 YEARS WAS LOW (15.2% VS 14.7%) AS WAS THE INCIDENCE OF DEFINITE OR PROBABLE STENT THROMBOSIS. THE MAIN ENDPOINT, TVF, OCCURRED IN 93 OF 1,243 PATIENTS (7.6%) ASSIGNED TO ZES. IT WAS STATED THAT RESULTS FOR THE MAIN ENDPOINT WERE CONSISTENT ACROSS VARIOUS SUBGROUPS. ADVERSE CLINICAL EVENT RATES IN THESE SMALL VESSEL PATIENT COHORT WERE SIMILAR TO RATES IN THE ENTIRE STUDY POPULATION. IT WAS ALSO STATED THAT IN THE RESOLUTE ONYX ZES COHORT, THE 2-YEAR DEFINITE STENT THROMBOSIS RATE WAS 0.4%." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/09/2020;04/09/2021" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-06974", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200526", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200526", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191010", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200526", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211009", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024609759", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840176", "udi_public": "08714729840176", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200526", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200526", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10086845", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200427", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191986186", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE EVENT DATE WAS NOTE REPORTED. THE FIRST DATE OF THE MONTH OF THE AWARE DATE WAS ENTERED AS AN ESTIMATE. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "191986187", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND CALCIFIED VESSEL. FOLLOWING PRE-DILATATION WITH A 2.5 X 15MM APEX BALLOON CATHETER, A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS. UPON REMOVAL, IT WAS NOTED THAT THE STENT DEVELOPED A BURR. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-06239", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200601", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200311", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200601", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191029", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200601", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211028", "model_number": "10602", "catalog_number": "10602", "lot_number": "0024727594", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840121", "udi_public": "08714729840121", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200601", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200601", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10105762", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200505", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193130782", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "193131343", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.50X16MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF FROM THE BALLOON INTO THE GUIDE. THE DEVICES WERE COMPLETELY REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07226", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200602", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200602", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200602", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210107", "model_number": "10604", "catalog_number": "10604", "lot_number": "0023208027", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200603", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840220", "udi_public": "08714729840220", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Contamination with Chemical or Other Material" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/01/2020", "manufacturer_contact_country": "", "date_changed": "20230724", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200602", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200707", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10111478", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193417335", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATE: ESTIMATED BASED ON AWARE DATE OF (B)(6) 2020. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "193417336", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS DEVICE WAS RECEIVED WITH A NOTE WRITTEN ON THE BOX \"DEFECTIVE- FUZZ ON STENT STRAIGHT OUT HOOP\". HOWEVER, UPON REVIEW OF THE DEVICE, IT WAS REVEALED THAT A FOREIGN MATERIAL WAS PRESENT ON THE DEVICE." }, { "mdr_text_key": "319557544", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS DEVICE WAS RECEIVED WITH A NOTE WRITTEN ON THE BOX \"DEFECTIVE- FUZZ ON STENT STRAIGHT OUT HOOP\". HOWEVER, UPON REVIEW OF THE DEVICE, IT WAS REVEALED THAT A FOREIGN MATERIAL WAS PRESENT ON THE DEVICE." }, { "mdr_text_key": "319557545", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3: EVENT DATE - ESTIMATED BASED ON AWARE DATE OF (B)(6) 2020. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.75 X 24 MM STENT DELIVERY SYSTEM CATHETER WAS RETURNED FOR ANALYSIS COILED IN ITS HOOP. THE HOOP WAS ENCLOSED WITHIN AN OPENED SHELF CARTON. SOME CREASING DAMAGE WAS NOTED TO BOX AND THE SEAL WAS OPEN. WRITTEN IN MARKER ON THE BOX WAS: '* DEFECTIVE * FUZZ ON STENT STRAIGHT OUT OF HOOP.' WHEN WITHDRAWING THE DEVICE FROM THE HOOP A PIECE A FIBROUS FM (FOREIGN MATTER) WAS NOTED AND IT WAS NOT ATTACHED TO THE HOOP OR THE DEVICE. THE FIBROUS FM WAS WHITE IN COLOR AND APPROXIMATIVELY 3MM IN LENGTH. THE FM WAS PLACED IN A LABELED CONTAINER AND AWAITS FTIR TESTING. NO PRODUCT MANDREL OR STENT PROTECTOR WAS RETURNED WITH THE DEVICE. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. THE CRIMPED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. THE SAMPLE WAS COMPARED TO A LIBRARY OF SAMPLES FROM THE DATA BASE OF THE MATERIAL CHARACTERIZATION LAB INCLUDING DIFFERENT MATERIALS PRESENT IN THE DES MANUFACTURING CLEANROOM HOWEVER NO MATCHES WERE FOUND. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/07/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-06227", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200602", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200505", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200602", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190819", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200602", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210818", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024339499", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840190", "udi_public": "08714729840190", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200602", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "83 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200602", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10111702", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200506", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193734794", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "193734795", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-06269", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200602", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200505", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200602", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191218", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200602", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211217", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024978300", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840152", "udi_public": "08714729840152", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Failure to Advance" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200602", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20200602", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10112054", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200506", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193616759", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "193616760", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PATIENT CONDITION DETERIORATED. A 2.50 X 20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND CAUSED A SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE NEEDED TO BE PERFORMED QUICKLY AS THE PATIENT CONDITION WAS DETERIORATING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-06307", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200603", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200507", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200603", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Rupture", "Failure to Advance", "Material Split, Cut or Torn" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/12/2020", "manufacturer_contact_country": "", "date_changed": "20230905", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200708", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10114589", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193733153", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT BALLOON TEAR OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 2.5X38 NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE BALLOON WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE." }, { "mdr_text_key": "319843313", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 2.5X38 NC EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "319843314", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D1: \"NC EMERGE\" WAS UPDATED TO \"SYNERGY.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/08/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07574", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200605", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200522", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200605", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200605", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210303", "model_number": "10607", "catalog_number": "10607", "lot_number": "0023506350", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200615", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840428", "udi_public": "08714729840428", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/09/2020;07/14/2020", "manufacturer_contact_country": "", "date_changed": "20230906", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200605", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10123165", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "317910885", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT CROSS THE LESION EVEN AFTER REPEATED ATTEMPTS AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "317910886", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3: UPDATED EVENT DATE B3 DATE OF EVENT: USED THE FIRST DAY OF THE MONTH OF THE BSC AWARE DATE SINCE EVENT DATE NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194136617", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: USED THE FIRST DAY OF THE MONTH OF THE BSC AWARE DATE SINCE EVENT DATE NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194136618", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT CROSS THE LESION EVEN AFTER REPEATED ATTEMPTS AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "319841033", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3: UPDATED EVENT DATE. B3 DATE OF EVENT: USED THE FIRST DAY OF THE MONTH OF THE BSC AWARE DATE SINCE EVENT DATE NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: SYNERGY II US MR 3.50 X 38MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS FROM THE PROXIMAL END OF THE STENT WERE LIFTED AND PULLED DISTALLY. THE UNDAMAGED STENT WAS MEASURED USING SNAP GAUGE AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION." }, { "mdr_text_key": "319841034", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 38 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT COULD NOT CROSS THE LESION AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/25/2020;07/20/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-06596", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200608", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200511", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200608", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190819", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200608", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210818", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024339499", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840190", "udi_public": "08714729840190", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200608", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200608", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10130578", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200512", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "194389054", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194389055", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 4.00X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS ADVANCED, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-07758", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200609", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200603", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200609", "manufacturer_contact_f_name": "JAY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200609", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200609", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200609", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10134587", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC IRELAND LIMITED", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "194528326", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194528327", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.0X20MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE BOX, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE DEVICE WAS NEVER INTRODUCED INTO THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07553", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200609", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200518", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200609", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200609", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200923", "model_number": "10605", "catalog_number": "10605", "lot_number": "0022734901", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200605", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840312", "udi_public": "08714729840312", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Difficult to Advance", "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/23/2020", "manufacturer_contact_country": "", "date_changed": "20230719", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200609", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200714", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10135394", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200518", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "194547431", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194547432", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT WAS DAMAGED UPON REMOVAL. THE TARGET LESION WAS IN THE SEVERELY TORTUOUS AND CALCIFIED PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY. A 4.00X28 AND 4.00X16 SYNERGY DRUG ELUTING STENT WERE USED FOR TREATMENT TOGETHER WITH THE GUIDEZILLA GUIDE EXTENSION CATHETER. DURING THE PROCEDURE, TWO SYNERGY STENTS WERE DEPLOYED IN THE VESSEL AND A NON-BSC STENT WAS USED DISTAL TO THE TWO SYNERGY. SUBSEQUENTLY, THE 4.00X28 STENT WAS PLACED INTO THE VESSEL BUT COULD NOT ADVANCE TO THE DISTAL LESION. THE STENT WAS REMOVED FROM THE BODY AND IT WAS NOTED TO BE UNRAVELED. THEN, A 4.0X16 STENT WAS ADVANCED IN THE GUIDEZILLA HOWEVER IT COULD NOT PASS THE TRANSITION PART OF THE GUIDEZILLA. THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED BUT THE STENT WAS STUCK IN THE SHAFT OF THE CO-PILOT TUOHY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO HARM TO THE PATIENT." }, { "mdr_text_key": "319285925", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED STENT FOUND THAT IT WAS DAMAGED ON ITS ENTIRE LENGTH BUT NOT EXPANDED. THE DAMAGE CONSISTED OF A STRETCHING OF ALL EXCEPT 4 STRUT ROWS LOCATED AT ONE END OF THE STENT. A MANUFACTURING CRIMPS STENT DATA WAS PERFORMED AND SINCE THE STENT DELIVERY SYSTEM WAS NOT RETURNED WITH THE STENT ALL 595 RESULTS RECORDED DURING CRIMPING WERE REVIEWED. ALL DEVICES PASSED THE CRIMPING MEASUREMENT TEST WITH RESULTS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON, TIP OF THE DEVICE, HYPOTUBE SHAFT AND SHAFT POLYMER EXTRUSION COULD NOT BE REVIEWED AS THEY WERE NOT RETURNED. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319285926", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT WAS DAMAGE UPON REMOVAL. THE TARGET LESION WAS IN THE SEVERELY TORTUOUS AND CALCIFIED PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY. A 4.00X28 AND 4.00X16 SYNERGY DRUG ELUTING STENTS WERE USED FOR TREATMENT TOGETHER WITH THE GUIDEZILLA GUIDE EXTENSION CATHETER. DURING THE PROCEDURE, TWO SYNERGY STENTS WERE DEPLOYED IN THE VESSEL AND A NON-BSC STENT WAS USED DISTAL TO THE TWO SYNERGY STENTS. SUBSEQUENTLY, THE 4.00X28 STENT WAS PLACED INTO THE VESSEL BUT COULD NOT ADVANCE TO THE DISTAL LESION AND GOT UNRAVELED WHEN REMOVED FROM THE PATIENT'S BODY. THEN, A 4.0X16 STENT WAS ADVANCED IN THE GUIDEZILLA HOWEVER IT COULD NOT PASS THE TRANSITION PART. THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED BUT THE STENT WAS STUCK IN THE SHAFT OF THE CO-PILOT TUOHY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THERE WAS NO HARM ON THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS RESISTANCE ON BOTH ISSUES. THE FIRST SYNERGY WOULD NOT PASS THROUGH THE NEWLY DEPLOYED TWO SYNERGY STENTS AS IT MAY HAVE BEEN GETTING CAUGHT ON THE OTHER STRUTS. THE OTHER SYNERGY STENT WOULD NOT PASS THROUGH THE COLLAR OF THE GUIDEZILLA. THERE WAS NO PROBLEM NOTED WITH THE GUIDEZILLA DURING ADVANCEMENT AND REMOVAL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/14/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07554", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200609", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200518", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200609", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200609", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200828", "model_number": "10602", "catalog_number": "10602", "lot_number": "0022618540", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840138", "udi_public": "08714729840138", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device-Device Incompatibility", "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/23/2020", "manufacturer_contact_country": "", "date_changed": "20230721", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200609", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200714", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10135412", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200518", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319516042", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "319516043", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT WAS DISLODGED UPON REMOVAL OF THE DELIVERY SYSTEM. THE TARGET LESION WAS IN THE SEVERELY TORTUOUS AND CALCIFIED PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY. A 4.00X28 AND 4.00X16 SYNERGY DRUG ELUTING STENT WERE USED FOR TREATMENT TOGETHER WITH THE GUIDEZILLA GUIDE EXTENSION CATHETER. DURING THE PROCEDURE, TWO SYNERGY STENTS WERE DEPLOYED IN THE VESSEL AND A NON-BSC STENT WAS USED DISTAL TO THE TWO SYNERGY. SUBSEQUENTLY, THE 4.00X28 STENT WAS PLACED INTO THE VESSEL BUT COULD NOT ADVANCE TO THE DISTAL LESION. THE STENT WAS REMOVED FROM THE BODY AND IT WAS NOTED TO BE UNRAVELED. THEN, A 4.0X16 STENT WAS ADVANCED IN THE GUIDEZILLA HOWEVER IT COULD NOT PASS THE TRANSITION PART OF THE GUIDEZILLA. THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED BUT THE STENT WAS STUCK IN THE SHAFT OF THE CO-PILOT TUOHY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO HARM TO THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS RESISTANCE ON BOTH ISSUES. THE FIRST SYNERGY WOULD NOT PASS THROUGH THE NEWLY DEPLOYED TWO SYNERGY STENTS AS IT MAY HAVE BEEN GETTING CAUGHT ON THE OTHER STRUTS. THE OTHER SYNERGY STENT WOULD NOT PASS THROUGH THE COLLAR OF THE GUIDEZILLA. THERE WAS NO PROBLEM NOTED WITH THE GUIDEZILLA DURING ADVANCEMENT AND REMOVAL." }, { "mdr_text_key": "194546970", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194546971", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT WAS DISLODGED UPON REMOVAL OF THE DELIVERY SYSTEM. THE TARGET LESION WAS IN THE SEVERELY TORTUOUS AND CALCIFIED PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY. A 4.00X28 AND 4.00X16 SYNERGY DRUG ELUTING STENT WERE USED FOR TREATMENT TOGETHER WITH THE GUIDEZILLA GUIDE EXTENSION CATHETER. DURING THE PROCEDURE, TWO SYNERGY STENTS WERE DEPLOYED IN THE VESSEL AND A NON-BSC STENT WAS USED DISTAL TO THE TWO SYNERGY. SUBSEQUENTLY, THE 4.00X28 STENT WAS PLACED INTO THE VESSEL BUT COULD NOT ADVANCE TO THE DISTAL LESION. THE STENT WAS REMOVED FROM THE BODY AND IT WAS NOTED TO BE UNRAVELED. THEN, A 4.0X16 STENT WAS ADVANCED IN THE GUIDEZILLA HOWEVER IT COULD NOT PASS THE TRANSITION PART OF THE GUIDEZILLA. THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED BUT THE STENT WAS STUCK IN THE SHAFT OF THE CO-PILOT TUOHY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO HARM TO THE PATIENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/14/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-06966", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200610", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200610", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20200210", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200610", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220209", "model_number": "10602", "catalog_number": "10602", "lot_number": "0025217958", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840138", "udi_public": "08714729840138", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200610", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200610", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10137481", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "194626216", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: USED THE 1ST DAY OF THE MONTH OF THE BSC AWARE DATE AS NO EVENT DATE WAS PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194626217", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 4.00 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER IT WAS NOTED THAT THE SHAFT WAS BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-07827", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200610", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200515", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200610", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190702", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200610", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210630", "model_number": "10601", "catalog_number": "10601", "lot_number": "0024049786", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840022", "udi_public": "08714729840022", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200610", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200610", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10139641", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200515", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "194698546", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194698547", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND THE SHAFT WAS BROKEN. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2134265-2020-06823", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200610", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200512", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200610", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200610", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20190114", "model_number": "UNK", "catalog_number": "UNK", "lot_number": "0022054982", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/15/2020", "manufacturer_contact_country": "", "date_changed": "20230728", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200610", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina" ] } ], "distributor_city": "", "date_report": "20200806", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10140071", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200518", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319935639", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "EVOLVE 48 CLINICAL STUDY IT WAS REPORTED THAT STABLE ANGINA OCCURRED. IN (B)(6) 2018, THE SUBJECT'S QALIFIYING CODITION INDICATES AS STABLE ANGINA. PRIOR TO PROCEDURE, THE SUBJECT WAS FOUND TO HAVE OTHER OBJECTIVE EVIDENCE OF ISCHEMIA. SUBSEQUENTLY, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION #1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO MID LAD WITH 80% STENOSIS AND WAS 40 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00 X 48 MM STUDY STENT. FOLLOWED BY POST DILATATION AND THE RESIDUAL STENOSIS WAS 10%. ONE DAY POST PROCEDURE, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2020, THE SUBJECT WAS DIAGNOSED WITH STABLE ANGINA. ACTION TAKEN IN RESPONSE TO THE EVENT WAS MEDICATION AND ANGIOGRAPHY WITHOUT REVASCULARIZATION AND THE OUTCOME OF THE EVENT IS RECOVERING/RESOLVING. IT WAS FURTHER REPORTED THAT POST INDEX PROCEDURE, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WHICH REVEALED WELL OPPOSED STENT AND AT THE OSTIUM OF D2 THERE WAS A PINCH NOTED BY 50% WITH GOOD FLOW. IN (B)(6) 2019, AT THE TIME 1 YEAR FOLLOW UP VISIT, THE SUBJECT HAD COMPLAINED ABOUT CHEST PAIN WITH EXERTION WHICH WAS NITROGLYCERIN RESPONSIVE. SUBJECT ALSO MENTIONED ABOUT FLUID RETENTION AND ABDOMINAL BLOATING ASSOCIATED WITH LOWER EXTREMITY EDEMA THAT WOULD RESOLVE WITH AN EXTRA BUMEX. THE SUBJECT DENIED SHORTNESS OF BREATH (SOB), EXERTIONAL DYSPNEA, PAROXYSMAL NOCTURNAL DYSPNEA (PND), PALPITATIONS, PRESYNCOPE, SYNCOPE OR NAUSEA. ADDITIONALLY, IN (B)(6) 2020, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT FOR A FOLLOW UP WITH COMPLAINT OF ONGOING CHEST PAIN THAT OCCURRED MOSTLY WHEN SHE WALKED MORE THAN 1.5 MILES. SUBJECT ALSO STATED THAT SHE HAD EXPERIENCED SIMILAR CHEST PAIN A FEW DAYS BACK POST HOUSEHOLD WORK AND LONG ACTING DOSAGE OF NITRATE WAS INCREASED. FURTHERMORE, SUBJECT WAS ALSO FOUND TO HAVE FLUID RETENTION RESULTING TO ABDOMINAL BLOATING AND WEIGHT GAIN OF MORE THAN 8LBS. SUBJECT TOOK AN EXTRA BUMEX TO REDUCE BLOATING, WHICH WAS ASSOCIATED WITH LOWER EDEMA AND SHORTNESS OF BREATH. SUBJECT HAD EXPERIENCED A NOTABLE EPISODE OF FLUID RETENTION 6 MONTHS BACK. ELECTROCARDIOGRAM REPORT ON THE SAME DAY REVEALED NO ACUTE CHANGES. SUBJECT ALSO HAD A SIMILAR EPISODE OF FLUID RETENTION DURING THIS VISIT. ON THE NEXT DAY, ECHOCARDIOGRAM REPORTED GRADE I DIASTOLIC DYSFUNCTION WITH NORMAL LEFT AND RIGHT VENTRICULAR SIZE AND SYSTOLIC FUNCTION, 55-60% EJECTION FRACTION (EF). NO EVIDENCE OF PERICARDIAL EFFUSION OR SIGNIFICANT VALVULAR ABNORMALITIES WERE NOTED. IT WAS ALSO NOTED THAT GRADE I DIASTOLIC DYSFUNCTION COULD HAVE POTENTIALLY LED TO OCCASIONAL FLUID RETENTION. HOWEVER, THE SAME IS NOT A MAJOR ISSUE. TWO DAYS LATER, CORONARY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED, SHORT LEFT MAIN CORONARY ARTERY (LMCA) WITH NO SIGNIFICANT FINDINGS, <10% IN STENT RESTENOSIS IN LONG STENT IN PROXIMAL AND MID PART OF LAD AND 80% OSTIAL STENOSIS IN DIAGONAL D3, 30% STENOSIS IN DISTAL LEFT CIRCUMFLEX ARTERY (LCX), 40% STENOSIS IN LEFT POSTEROLATERAL BRANCH (LPL) 1 BRANCH; NORMAL OBTUSE MARGINAL (OM)1, OM2 AND 2ND LPL AND LEFT POSTERIOR DESCENDING ARTERY (LPDA), 30% STENOSIS IN MID RIGHT CORONARY ARTERY (RCA) AND 60% EF, NO MITRAL REGURGITATION (MR). SUBJECT DID NOT REQUIRE ANY PCI AND NITRATE DOSAGE WAS FURTHER INCREASED. POST ANGIOGRAPHY, NO COMPLICATIONS WERE NOTED. SUBJECT WAS DISCHARGED TO HOME AND WAS ADVISED FOR AGGRESSIVE WEIGHT REDUCTION DIET AND A FOLLOW UP IN 6 WEEKS." }, { "mdr_text_key": "319935640", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194699722", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194699803", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "(B)(6). IT WAS REPORTED THAT STABLE ANGINA OCCURRED. IN (B)(6) 2018, CLINICAL ASSESSMENT INDICATES THE SUBJECT'S QUALIFYING CONDITION AS STABLE ANGINA. PRIOR TO PROCEDURE, THE SUBJECT WAS FOUND TO HAVE OTHER OBJECTIVE EVIDENCE OF ISCHEMIA. SUBSEQUENTLY, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO MID LAD WITH 80% STENOSIS AND WAS 40 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00X48 MM SYNERGY STENT. FOLLOWED BY POST-DILATATION AND THE RESIDUAL STENOSIS WAS 10%. ONE DAY POST PROCEDURE, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2020, THE SUBJECT WAS DIAGNOSED WITH STABLE ANGINA. MEDICATION WAS GIVEN AND ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED. THE EVENT WAS CONSIDERED RESOLVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/06/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07892", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200608", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211006", "model_number": "10604", "catalog_number": "10604", "lot_number": "0024590883", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840213", "udi_public": "08714729840213", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/30/2020", "manufacturer_contact_country": "", "date_changed": "20230720", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200717", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10143976", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200608", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319388622", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. UPDATED B5: DESCRIBE EVENT OR PROBLEM." }, { "mdr_text_key": "319388623", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AFTER PRE-DILATION WAS PERFROMED WITH A 2.50X15MM EMERGE BALLOON CATHETER , A 2.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS ALSO NOTED THAT THE STENT STRUTS WERE DAMAGED WHEN TRYING TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME. IT WAS FURTHER REPORTED THAT WRONG STENT SIZE WAS PULLED. SUBSEQUENTLY, AN ADDITIONAL STENT WAS ADVANCED AND THE PROCEDURE WAS COMPLETED WITHOUT CONSEQUENCES." }, { "mdr_text_key": "194837460", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194837461", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AFTER PRE-DILATION WAS PERFORMED WITH A 2.50X15MM EMERGE BALLOON CATHETER , A 2.50 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS ALSO NOTED THAT THE STENT STRUTS WERE DAMAGED WHEN TRYING TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/17/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-06936", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210806", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024271367", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840145", "udi_public": "08714729840145", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/08/2020", "manufacturer_contact_country": "", "date_changed": "20230802", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200625", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10144066", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "317906010", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE DEVICE BROKE AND WAS UNABLE TO CROSS THE LESION. NO PATIENT COMPLCIATIONS WERE REPORTED. IT WAS FURTHER REPORTED THE TARGET LESION WAS 80% STENOSED AND WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE BREAK OCCURRED APPROXIMATELY 40CM FROM THE HUB. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE." }, { "mdr_text_key": "317906011", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3 - DATE OF EVENT: USED (B)(6) 2020 SINCE THERE WAS NO DATE PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194837082", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: USED (B)(6) 2020 SINCE THERE WAS NO DATE PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194837183", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE DEVICE BROKE AND WAS UNABLE TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/25/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-06991", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200519", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200612", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191007", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211006", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024612501", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840190", "udi_public": "08714729840190", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20200612", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10148521", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "194976940", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "194976941", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN MODERATELY TURTOUOS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 4.00X20MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS ADVANCED THROUGH ANOTHER DEPLOYED STENT, IT WOULD NOT ADVANCED. AS THE PHYSICIAN REMOVED THE DEVICE, THE STENT WAS DISLODGED ON THE PREVIOUSLY DEPLOYED STENT AND MIGRATED INTO THE AORTA. A SNARE WAS USED TO RETRIEVE THE STENT FULLY INTACT. THE PHYSICIAN DID NOT ATTEMPT TO PLACE ANOTHER STENT AFTER THAT. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-08115", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200616", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200610", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200616", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200616", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211217", "model_number": "10604", "catalog_number": "10604", "lot_number": "0024998025", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200728", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840244", "udi_public": "08714729840244", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/24/2020", "manufacturer_contact_country": "", "date_changed": "20230719", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200616", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200916", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10160107", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200611", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195390334", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "195390335", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USED. HOWEVER, THE DEVICE WAS FOUND TO BE FLARED UPON REMOVAL FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "319325019", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USED. HOWEVER, THE DEVICE WAS FOUND TO BE FLARED UPON REMOVAL FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "319325020", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATED BY MFR: SYNERGY II US MR 3.50 X 24MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. THE CRIMPED STENT OUTER DIAMETER WAS MEASURED AND WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED SIGNS OF DISTAL TIP DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/16/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-07586", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200617", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200617", "manufacturer_contact_f_name": "JAY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200617", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "10603", "catalog_number": "10603", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200617", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200617", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10161703", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200601", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195369918", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "195369919", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT STRUT APPEARED TO BE LIFTED OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2134265-2020-07208", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200617", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200617", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200617", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220121", "model_number": "10605", "catalog_number": "10605", "lot_number": "0025137620", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200608", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840275", "udi_public": "08714729840275", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/08/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200617", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Embolism" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10164230", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200526", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318760801", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK AND EMBOLIZATION OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN, RISING TROPONINS, AND ELECTROCARDIOGRAM CHANGES WHICH IS CONSISTENT WITH ISCHEMIA. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DIAGONAL (DIAG) BRANCH. DUE TO DISEASE OF THE LAD AND ENLARGEMENT OF THE DIAG BRANCH, DOUBLE KISSING CRUSH TECHNIQUE WAS PERFORMED. AFTER A NON-BSC WIRE WAS USED TO CROSS THE LESION, PRE-DILATATION WAS PERFORMED. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED THROUGH THE DIAG; HOWEVER, IT HAD AN ISSUE WITH THE GUIDER AND COULD NOT PASS THE STENT INTO THE LAD. THE STENT WAS FROZEN IN PLACE AND WAS WRAPPED AROUND THE LAD BALLOON. THEY HAD TO BE DEPLOYED THE STENT IN THE DIAG. UPON REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE SHAFT FRACTURED IN THE GUIDER AND THE BALLOON SEPARATED FROM THE CATHETER. A PORTION OF THE DETACHED FRAGMENT REMAINED IN THE GUIDER WHERE IT WAS TRAPPED AND REMOVED. THE OTHER PORTION OF THE BALLOON EMBOLIZED TO THE DESCENDING AORTA AND WAS SUCCESSFULLY REMOVED USING A BIOPTOME DESPITE NUMEROUS UNSUCCESSFUL ATTEMPTS. AN 8F SHEATH WAS THEN PLACED AND WITH GUIDE LINER SUPPORT, A 1.25MM BALLOON CATHETER WAS ADVANCED PAST THE STENT PORTION FROM THE DIAG INTO THE LAD. PROGRESSION DILATATION WAS PERFORMED WITH MULTIPLE BALLOON CATHETERS WITH SIZES 1.25, 2.0, 2.5 RESPECTIVELY. THE LAD WAS THEN STENTED WITH A 2.75 X 38 SYNGERGY DES, FOLLOWED BY A 3.0 X 20 DES. THE DIAG WAS THEN RECROSSED AND SIMULTANEOUS KISSING BALLOON TECHNIQUES WERE PERFORMED AND THE LAD WAS POST-DILATED IN MULTIPLE LOCATIONS WITH A 3.25 NON-COMPLIANT BALLOON AT UP TO 18 ATMOSPHERES. ANGIOGRAPHY REVEALED EXCELLENT RESULT THROUGHOUT THE DIAG AND THE LAD. FEMORAL ANGIOGRAPHY SHOWED APPROPRIATE CATHETER PLACEMENT IN THE COMMON FEMORAL ARTERY AND THE PROCEDURE WAS COMPLETED AFTER CLOSURE OF THE CATH SITE WITH AN 8F NON-BSC DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "318760802", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. B3 DATE OF EVENT: USED THE FIRST DATE OF THE MONTH OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED. A PARTIAL SYNERGY II US MR 2.50 X 38 MM DEVICE FROM DISTAL TIP TO POLYMER EXTRUSION WAS RETURNED FOR ANALYSIS WITHOUT THE HYPOTUBE SHAFT INCLUDING THE HUB/MANIFOLD. A VISUAL EXAMINATION OF THE STENT FOUND THE STENT WAS NOT RETURNED FOR ANALYSIS SINCE IT HAD BEEN DEPLOYED IN THE PATIENT. THE BALLOON BODY WAS REVIEWED; AND NO ISSUES WERE NOTED. BLOOD LIKE SUBSTANCE IN THE BALLOON AND INFLATION LUMEN OF THE DISTAL SHAFT WAS OBSERVED DURING ANALYSIS. THERE WAS INDICATION THAT POSITIVE AND NEGATIVE PRESSURE WERE APPLIED TO BALLOON. A VISUAL AND MICROSCOPIC EXAMINATION OF THE TIP SHOWED SIGNS OF DAMAGE ON THE DISTAL EDGE OF THE TIP. TIP DAMAGE MOST LIKELY OCCURRED WHEN THE TIP WAS PUSHED AGAINST A RESTRICTION. THE HYPOTUBE SECTION OF THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE OUTER EXTRUSION AND MID-SHAFT SECTION AND VISUAL EXAMINATION OF THE INNER EXTRUSION FOUND A BREAK IN THE POLYMER EXTRUSION SECTION AT 255 MM PROXIMAL TO DISTAL TIP (THE BREAK WAS IN THE PORT BOND, WITHIN THE EXCHANGE PORT). THIS TYPE OF DAMAGE MOST LIKELY OCCURRED DUE TO EXCESSIVE FORCE THAT COULD HAVE BEEN APPLIED TO THE DELIVERY SYSTEM DURING WITHDRAWAL ATTEMPTS. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "195452451", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DATE OF EVENT: USED THE FIRST DATE OF THE MONTH OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED. AGE: (B)(6)." }, { "mdr_text_key": "195452452", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK AND EMBOLIZATION OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN, RISING TROPONINS, AND ELECTROCARDIOGRAM CHANGES WHICH IS CONSISTENT WITH ISCHEMIA. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DIAGONAL (DIAG) BRANCH. DUE TO DISEASE OF THE LAD AND ENLARGEMENT OF THE DIAG BRANCH, DOUBLE KISSING CRUSH TECHNIQUE WAS PERFORMED. AFTER A NON-BSC WIRE WAS USED TO CROSS THE LESION, PRE-DILATATION WAS PERFORMED. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED THROUGH THE DIAG; HOWEVER, IT HAD AN ISSUE WITH THE GUIDER AND COULD NOT PASS THE STENT INTO THE LAD. THE STENT WAS FROZEN IN PLACE AND WAS WRAPPED AROUND THE LAD BALLOON. THEY HAD TO BE DEPLOYED THE STENT IN THE DIAG. UPON REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE SHAFT FRACTURED IN THE GUIDER AND THE BALLOON SEPARATED FROM THE CATHETER. A PORTION OF THE DETACHED FRAGMENT REMAINED IN THE GUIDER WHERE IT WAS TRAPPED AND REMOVED. THE OTHER PORTION OF THE BALLOON EMBOLIZED TO THE DESCENDING AORTA AND WAS SUCCESSFULLY REMOVED USING A BIOPTOME DESPITE NUMEROUS UNSUCCESSFUL ATTEMPTS. AN 8F SHEATH WAS THEN PLACED AND WITH GUIDE LINER SUPPORT, A 1.25MM BALLOON CATHETER WAS ADVANCED PAST THE STENT PORTION FROM THE DIAG INTO THE LAD. PROGRESSION DILATATION WAS PERFORMED WITH MULTIPLE BALLOON CATHETERS WITH SIZES 1.25, 2.0, 2.5 RESPECTIVELY. THE LAD WAS THEN STENTED WITH A 2.75 X 38 SYNGERGY DES, FOLLOWED BY A 3.0 X 20 DES. THE DIAG WAS THEN RECROSSED AND SIMULTANEOUS KISSING BALLOON TECHNIQUES WERE PERFORMED AND THE LAD WAS POST-DILATED IN MULTIPLE LOCATIONS WITH A 3.25 NON-COMPLIANT BALLOON AT UP TO 18 ATMOSPHERES. ANGIOGRAPHY REVEALED EXCELLENT RESULT THROUGHOUT THE DIAG AND THE LAD. FEMORAL ANGIOGRAPHY SHOWED APPROPRIATE CATHETER PLACEMENT IN THE COMMON FEMORAL ARTERY AND THE PROCEDURE WAS COMPLETED AFTER CLOSURE OF THE CATH SITE WITH AN 8F NON-BSC DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07169", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200618", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200522", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200618", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200618", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211218", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024977493", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200624", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840411", "udi_public": "08714729840411", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break", "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/29/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230901", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200810", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10169393", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200526", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195739443", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "195739444", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR LEFT HEART CATHETERIZATION. THE STENT WAS DEPLOYED; HOWEVER, AS THE STENT DELIVERY SYSTEM WAS BEING REMOVED, THE BALLOON GOT STUCK ON THE GUIDEWIRE AND WAS STRETCHED. THE GUIDEWIRE AND STENT DELIVERY SYSTEM WERE REMOVED TOGETHER WITH NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED." }, { "mdr_text_key": "319767307", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION HAS OVER 90% STENOSIS. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR LEFT HEART CATHETERIZATION. FOLLOWING PREDILATATION, THE STENT WAS DEPLOYED. HOWEVER, AS THE THE STENT DELIVERY SYSTEM WAS BEING REMOVED, THE BALLOON GOT STUCK ON THE GUIDEWIRE AND WAS STRETCHED. THE GUIDEWIRE AND STENT DELIVERY SYSTEM WERE REMOVED TOGETHER WITH NO HARM TO PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED." }, { "mdr_text_key": "319767308", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATION BY MFR: SYNERGY II US MR 3.00 X 38MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED WITHOUT THE STENT. THE BALLOON WAS REVIEWED, AND ISSUES WERE NOTED. NO STENT WAS ATTACHED TO THE BALLOON AND THE BALLOON APPEARED TO BE IN A DEFLATED STATE WITH A BLOOD LIKE SUBSTANCE IN THE BALLOON. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND A BREAK IN THE POLYMER EXTRUSION 35.3CM PROXIMAL TO THE DISTAL END OF THE DISTAL TIP, WHICH IS THE THE EXCHANGE PORT LOCATION, EXPOSING THE CORE WIRE. DAMAGE WAS ALSO NOTED AT POINTS ALL ALONG THE SHAFT POLYMER EXTRUSION IN THE FORM OF MULTIPLE KINKS AND STRETCHING. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319205313", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR LEFT HEART CATHETERIZATION. THE STENT WAS DEPLOYED; HOWEVER, AS THE THE STENT DELIVERY SYSTEM WAS BEING REMOVED, THE BALLOON GOT STUCK ON THE GUIDEWIRE AND WAS STRETCHED. THE GUIDEWIRE AND STENT DELIVERY SYSTEM WERE REMOVED TOGETHER WITH NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAD OVER 90% STENOSIS AND WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED ARTERY. THE LESION WAS ALSO PREDILATED, HOWEVER, THE STENOSIS WAS ROUGHLY THE SAME FOLLOWING PREDILATATION." }, { "mdr_text_key": "319205314", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/15/2020;08/10/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-07470", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200618", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200526", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200618", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20180809", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200618", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200808", "model_number": "10605", "catalog_number": "10605", "lot_number": "0022552453", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840299", "udi_public": "08714729840299", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "78 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200618", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10169619", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200526", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195616130", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "195616131", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT MOVEMENT ON THE BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND HEAVILY CALCIFIED CIRCUMFLEX ARTERY. A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT SLIGHTLY SHIFTED OFF THE BALLOON. THE STENT WAS DEPLOYED PROXIMAL TO THE LESION AND WAS FULLY EXPANDED. AN ADDITIONAL SYNERGY STENT WAS DEPLOYED IN THE CIRCUMFLEX AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-08299", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200611", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "10607", "catalog_number": "10607", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/25/2020", "manufacturer_contact_country": "", "date_changed": "20230831", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200714", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10178734", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200616", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195918361", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "195918362", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 38MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS TOOK OUT THE FROM THE PACKAGE, STENT DAMAGED WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "319192103", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 38MM SYNERGY II DRUG-ELUTING STENT WAS SELECED FOR USE. HOWEVER, WHEN THE DEVICE WAS TOOK OUT FROM THE PACKAGE, STENT DAMAGED WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A DIFFERENT PRODUCT." }, { "mdr_text_key": "319192104", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. 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AFTER THE VESSEL WAS PRE-DILATED WITH A 2.50X15MM NON-BOSTON SCIENTIFIC BALLOON CATHETER, A 2.50 X 8MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT COULD NOT CROSS THE LESION AND WHEN IT WAS REMOVED, THE DEVICE WAS FOUND TO BE CRACKED. 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B3 DATE OF EVENT: USED THE FIRST DATE OF THE MONTH OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 4.00 X 38MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND STENT DAMAGE. THE DISTAL HALF OF THE STENT WAS PULLED DISTALLY EXTENDING PAST THE DISTAL TIP. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319692004", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED." }, { "mdr_text_key": "196118873", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DATE OF EVENT: USED THE FIRST DATE OF THE MONTH OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED." }, { "mdr_text_key": "196118874", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08425", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200623", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200615", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200623", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190930", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200623", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210929", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024577485", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840152", "udi_public": "08714729840152", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200623", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "76 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200623", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10186607", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200618", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196226303", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196226304", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, IT WAS NOTED THAT THE STENT STRUTS WERE MALFORMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS OKAY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2134265-2020-07666", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200624", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200624", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200624", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210818", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024325405", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200624", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840398", "udi_public": "08714729840398", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break", "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230724", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200810", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10189966", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200601", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319573142", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. B5 DESCRIBE EVENT OR PROBLEM UPDATED. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.50 X 38 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS WITHOUT THE DISTAL SECTION CONTAINING THE INNER/OUTER SHAFT POLYMER EXTRUSION, BALLOON AND STENT. A VISUAL EXAMINATION OF THE STENT, BALLOON, TIP PROFILES AND DISTAL END OF THE SHAFT POLYMER EXTRUSION PROFILE COULD NOT BE COMPLETED AS THE DEVICE WAS RETURNED WITHOUT THESE SECTIONS. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND A BREAK IN THE MIDSHAFT REGION OF THE SHAFT POLYMER EXTRUSION MEASURED AT 123.5 CM DISTAL TO DISTAL END OF THE STRAIN RELIEF. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319573143", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER USING A 1.5 ROTABLATOR BURR, A 2.5X15 WOLVERINE AND 2.5MM NC EMERGE BALLOON CATHETER WERE USED FOR PRE-DILATION. A 2.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE BALLOON WAS STUCK INSIDE THE STENT. ANOTHER BALLOON WAS INFLATED TO TRAP THE WIRE AND STENT DELIVERY SYSTEM SHAFT INSIDE THE GUIDE CATHETER. THE STENT BALLOON CAME FREE AS EVERYTHING WAS REMOVED TOGETHER. THE STENT REMAINED IMPLANTED AND WAS POST DILATED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT AFTER STENT DEPLOYMENT, THE SHAFT BROKE WHILE REMOVING THE DELIVERY SYSTEM." }, { "mdr_text_key": "196268730", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196268731", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER USING A 1.5 ROTABLATOR BURR, A 2.5X15 WOLVERINE AND 2.5MM NC EMERGE BALLOON CATHETER WERE USED FOR PRE-DILATION. A 2.50 X 38MM SYNERGY DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE BALLOON WAS STUCK INSIDE THE STENT. ANOTHER BALLOON WAS INFLATED TO TRAP THE WIRE AND STENT DELIVERY SYSTEM SHAFT INSIDE THE GUIDE CATHETER. THE STENT BALLOON CAME FREE AS EVERYTHING WAS REMOVED TOGETHER. THE STENT REMAINED IMPLANTED AND WAS POST DILATED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/10/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-07753", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200624", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200602", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200624", "manufacturer_contact_f_name": "JAY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200624", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20200624", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10190015", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC IRELAND LIMITED", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196265332", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196265333", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.5X28MM SYNERGY DRUG-ELUTING STENT (DES) WAS DEPLOYED FOR TREATMENT. HOWEVER, THE STENT ENDED UP ACCORDIONING. THE PHYSICIAN PLACED A SECOND 2.75X16 SYNERGY DES AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-08475", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200624", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "CONSUM" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200624", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200624", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210702", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024073085", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200706", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840435", "udi_public": "08714729840435", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/30/2020", "manufacturer_contact_country": "", "date_changed": "20230726", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200805", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10190063", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200621", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319768471", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING GUIDE CATHETER INSERTION, THE STENT WAS DAMAGED. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED." }, { "mdr_text_key": "319768472", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. B3 - DATE OF EVENT: USED THE FIRST DATE OF THE MONTH (01JUN2020) OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 4.00 X 38MM STENT DELIVERY SYSTEM CATHETER WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND THE STENT DAMAGED WITH STENT STRUT ROWS FROM THE PROXIMAL TO MID STENT REGION LIFTED AND BUNCHED DISTALLY IN THE MIDDLE REGION OF THE STENT. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON BODY WAS EXPOSED IN THE PROXIMAL TO MIDDLE BALLOON REGION WITH CRIMP MARKINGS VISIBLE ON THE BALLOON BODY. THE BALLOON CONES WERE REVIEWED NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL EXAMINATION OF THE BUMPER TIP FOUND NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "196271432", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DATE OF EVENT: USED THE FIRST DATE OF THE MONTH ((B)(6) 2020) OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED." }, { "mdr_text_key": "196271433", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING GUIDE CATHETER INSERTION, THE STENT WAS DAMAGED. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/05/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-08497", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200624", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200513", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200624", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200624", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220126", "model_number": "10602", "catalog_number": "10602", "lot_number": "0025178586", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840121", "udi_public": "08714729840121", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/20/2020", "manufacturer_contact_country": "", "date_changed": "20230727", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200917", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10191079", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200601", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319655091", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE AND STENT NOT ABLE TO CROSS LESION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.50 X 16 SYNERGY II DRUG ELUTING BIODEGRADABLE STENT WAS ADVANCED FRO TREATMENT. HOWEVER, THE PHYSICIAN HAD DIFFICULTY DELIVERING THE STENT AS WELL AND NOTICED UPON REMOVAL OF THE DEVICE THAT IT HAD A FLARED STENT STRUT IN THE MID PORTION OF THE STENT. THE VESSEL WAS PREPPED WITH A NC BALLOON AND COMPLETED THE PROCEDURE WITH ANOTHER STENT OF THE SAME SIZE. ANOTHER PROCEDURE WAS PERFORMED ON A MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12 SYNERGY II DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, PHYSICIAN HAD DIFFICULTY DELIVERING THE STENT AS WELL AND NOTICED UPON REMOVAL OF THE DEVICE THAT IT HAD A FLARED STENT STRUT IN THE MID PORTION OF THE STENT. PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED ON BOTH PROCEDURE. ." }, { "mdr_text_key": "319655092", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: SYNERGY II US MR 3.50 X 16MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS IN THE DISTAL REGION OF THE STENT WERE LIFTED AND PULLED IN A DISTAL DIRECTION. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "196326481", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196326482", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED IN RCA AND A 3.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED IN LAD. BOTH DEVICES FAILED TO CROSS AND THE STENT STRUTS WERE NOTED TO BE FLARED UPON REMOVAL. BOTH THE RCA AND LAD WERE DILATED WITH NC BALLOON CATHETERS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/17/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07550", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200624", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200513", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200624", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200624", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210526", "model_number": "10601", "catalog_number": "10601", "lot_number": "0023892826", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840053", "udi_public": "08714729840053", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/18/2020", "manufacturer_contact_country": "", "date_changed": "20230511", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200910", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10191083", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200601", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315019014", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 3.00 X 12MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS IN THE PROXIMAL AND MID SECTIONS WERE LIFTED AND PULLED IN A DISTAL DIRECTION. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "315019015", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE MILDY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED IN RCA AND A 3.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED IN LAD. BOTH DEVICES FAILED TO CROSS AND THE STENT STRUTS WERE NOTED TO BE FLARED UPON REMOVAL. BOTH THE RCA AND LAD WERE DILATED WITH NC BALLOON CATHETERS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT." }, { "mdr_text_key": "196328318", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196328319", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA) AND LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 16MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED IN RCA AND A 3.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED IN LAD. BOTH DEVICES FAILED TO CROSS AND THE STENT STRUTS WERE NOTED TO BE FLARED UPON REMOVAL. BOTH THE RCA AND LAD WERE DILATED WITH NC BALLOON CATHETERS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/10/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07669", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200624", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200624", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200624", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210909", "model_number": "10604", "catalog_number": "10604", "lot_number": "0024455130", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200624", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840251", "udi_public": "08714729840251", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break", "Entrapment of Device" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230901", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200810", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10191763", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200601", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319940491", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATION OF A 3.0MM AND 3.5MM NC EMERGE BALLOON CATHETER, A 4.00 X 24MM SYNERGY DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED PAST THE NOMINAL PRESSURE. HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE DEVICE WAS STUCK AND THE SHAFT BROKE INSIDE THE GUIDE CATHETER WHEN PULLED HARDER. THE GUIDE WAS PUSHED IN AS THE ENTIRE DELIVERY SYSTEM WAS PULLED OUT COMPLETELY. THE STENT WAS POST-DILATED WITH A 5.0MM NC EMERGE BALLOON CATHETER, COMPLETING THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "319940492", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 4.00 X 24MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED WITHOUT THE STENT ATTACHED. THE BALLOON CONES WERE REVIEWED, THE CONES WERE IDENTIFIED TO BE IN A DEFLATED STATE WITH A RED/BROWN SUBSTANCE VISIBLE. A VISUAL EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS AS WELL AS A RED/BROWN SUBSTANCE VISIBLE IN THE MANIFOLD. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND THE DEVICE BROKEN AT THE GUIDEWIRE EXCHANGE PORT 260MM PROXIMAL TO THE DISTAL TIP. THE COREWIRE WAS EXPOSED. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "196326703", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196326704", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATION OF A 3.0MM AND 3.5MM NC EMERGE BALLOON CATHETER, A 4.00 X 24MM SYNERGY DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED PAST THE NOMINAL PRESSURE. HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE DEVICE WAS STUCK AND THE SHAFT BROKE INSIDE THE GUIDE CATHETER WHEN PULLED HARDER. THE GUIDE WAS PUSHED IN AS THE ENTIRE DELIVERY SYSTEM WAS PULLED OUT COMPLETELY. THE STENT WAS POST-DILATED WITH A 5.0MM NC EMERGE BALLOON CATHETER, COMPLETING THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/10/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07761", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200625", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200625", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200625", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211218", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024977493", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200624", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840411", "udi_public": "08714729840411", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Fracture", "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/07/2020", "manufacturer_contact_country": "", "date_changed": "20230811", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200625", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10194989", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318789748", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. CORRECTION: B5: DESCRIBE EVENT OR PROBLEM UPDATED FROM STENT FRACTURE OCCURRED TO STENT DAMAGE OCCURRED. H6: DEVICE CODES UPDATED FROM FRACTURE TO MATERIAL DEFORMATION. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 3.00 X 38 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION VISUAL AND VIA SCOPE OF THE CRIMPED STENT FOUND STENT DAMAGE. STENT STRUTS FROM THE PROXIMAL END OF THE STENT WERE NOTED TO BE LIFTED FROM THEIR CRIMPED POSITION AND PULLED DISTALLY. THE UNDAMAGED CRIMPED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED SIGNS OF DISTAL TIP DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "318789749", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT ONE OF THE STRUTS APPEARED TO BE DISLODGED. NO FURTHER INFORMATION AVAILABLE." }, { "mdr_text_key": "196431563", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196431564", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT ONE OF THE STRUTS APPEARED TO BE DISLODGED. NO FURTHER INFORMATION AVAILABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08131", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200625", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200625", "manufacturer_contact_f_name": "JAY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200625", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200625", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200625", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10197637", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200605", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC IRELAND LIMITED", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196798994", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: DATE THE INCIDENT OCCURRED USED AS (B)(6) 2020 SINCE IT OCCURRED FEW MONTHS BACK. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196798995", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. A SYNERGY DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, DURING CATHETER REMOVAL, IT WAS NOTED THAT THE DEVICE WAS STICKING TO THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-07988", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200626", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200605", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200626", "manufacturer_contact_f_name": "JAY JOHNSON", "device_date_of_manufacturer": "20191002", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200626", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211001", "model_number": "10605", "catalog_number": "10605", "lot_number": "0024593816", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840299", "udi_public": "08714729840299", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device-Device Incompatibility", "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200626", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200626", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10200877", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200605", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196835053", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "196835054", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED AND HIGHLY TORTUOUS LEFT CIRCUMFLEX (LCX). A 3.00 X 28 SYNERGY II STENT WAS UNABLE TO CROSS THROUGH A WATCHDOG HEMOSTASIS VALVE AND THE STENT BECAME DAMAGED. THE WATCHDOG WAS REMOVED AND REPLACED WITH EXCHANGED WITH ANOTHER WATCHDOG. IT WAS NOTED THAT THE STENT WAS DAMAGED BY THE FIRST WATCHDOG, THUS CAUSING STENT TO DEFORM UPON PLACEMENT IN THE LCX. THE STENT WAS SUCCESSFULLY DEPLOYED AFTER MULTIPLE BALLOONS AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT A 2.5 X 20 APEX BALLOON WAS USED TO DILATE THE TARGET LESION. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Injury", "report_number": "2134265-2020-07984", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200626", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200626", "manufacturer_contact_f_name": "JAY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200626", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Deflation Problem", "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200626", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200626", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10201764", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200608", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC IRELAND LIMITED", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196678514", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DATE OF EVENT: USED THE FIRST DATE OF THE MONTH OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED." }, { "mdr_text_key": "196678515", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DIFFICULTY REMOVAL AND DEFLATION SLOW OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT MAIN CORONARY ARTERY TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON WITHDRAWAL, THE DEVICE WAS STUCK AND DIFFICULTY REMOVAL WAS ENCOUNTERED. IT WAS NOTED THAT THE BALLOON DID NOT DEFLATE ALL THE WAY. DIFFERENT TECHNIQUES WERE PERFORMED BEFORE DEVICE WAS COMPLETELY REMOVED. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-07847", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200630", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200608", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200630", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200630", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210806", "model_number": "10605", "catalog_number": "10605", "lot_number": "0024284396", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200624", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840275", "udi_public": "08714729840275", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/23/2020", "manufacturer_contact_country": "", "date_changed": "20230718", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200630", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200818", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10213580", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200608", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319241171", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.50 X 28 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION (VISUAL AND VIA SCOPE) OF THE CRIMPED STENT FOUND STENT DAMAGE. STENT STRUTS FROM THE MID STENT REGION WERE NOTED TO BE LIFTED FROM THEIR CRIMPED POSITION AND PULLED DISTALLY. THE UNDAMAGED CRIMPED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED SIGNS OF DISTAL TIP DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT AT 10MM AND 20MM DISTAL TO THE DISTAL END OF THE TIP. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND A KINK MEASURED AT 205 MM PROXIMAL TO THE DISTAL END OF THE TIP. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319241172", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR USE. HOWEVER, THE STENT WAS DAMAGED WHILE DELIVERING TO THE LESION OVER SAMURAI GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A 2.5X24MM SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS DOING GREAT." }, { "mdr_text_key": "197012903", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "197012904", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.50 X 28 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR USE. HOWEVER, THE STENT WAS DAMAGED WHILE DELIVERING TO THE LESION OVER SAMURAI GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A 2.5X24MM SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS DOING GREAT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/18/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2134265-2020-07987", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200630", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200605", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200630", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200630", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220202", "model_number": "10604", "catalog_number": "10604", "lot_number": "0025215885", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200624", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840213", "udi_public": "08714729840213", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Migration or Expulsion of Device" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/22/2020", "manufacturer_contact_country": "", "date_changed": "20230718", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200630", "sequence_number_treatment": [ "GUIDEWIRE: BMW", " GUIDEWIRE: BMW", " GUIDEWIRE: BMW" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200812", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10214451", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200608", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319202083", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE STENT WAS EXPLANTED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, A NON-BSC GUIDE WIRE BECAME ENTANGLED WITH THE NEWLY PLACED STENT AND WHEN TRYING TO RETRACT THE WIRE, THE STENT DISLODGED FROM THE CORONARY ARTERY AND STAYED ON THE WIRE UNTIL THE WIRE WAS RETRACTED TO THE FEMORAL ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DEPLOYED STENT OUT WITH A SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "319202084", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.50 X 24MM STENT WAS RETURNED FOR ANALYSIS. THE STENT WAS NOTED TO BE EXPANDED AND DAMAGED. THE STENT DELIVERY SYSTEM WAS NOT REURNED FOR ANALYSIS." }, { "mdr_text_key": "197013813", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "197013814", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE STENT WAS EXPLANTED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, A NON-BSC GUIDE WIRE BECAME ENTANGLED WITH THE NEWLY PLACED STENT AND WHEN TRYING TO RETRACT THE WIRE, THE STENT DISLODGED FROM THE CORONARY ARTERY AND STAYED ON THE WIRE UNTIL THE WIRE WAS RETRACTED TO THE FEMORAL ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DEPLOYED STENT OUT WITH A SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/12/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08099", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200701", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200610", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200701", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190910", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200701", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210909", "model_number": "10604", "catalog_number": "10604", "lot_number": "0024455130", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840251", "udi_public": "08714729840251", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device-Device Incompatibility", "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200701", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200701", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10218979", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200611", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "197160610", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "197160611", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 24 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS IN AND OUT OF THE GUIDE CATHETER FIVE TIMES; HOWEVER, DURING THE LAST TIME, THE STENT WAS CAUGHT IN THE GUIDE OR TUOHY BORST. UPON REMOVAL, IT WAS NOTICED THAT THE STENT STRUTS AT THE PROXIMAL END OF THE STENT WERE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08088", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200701", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200611", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200701", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191104", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200701", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211103", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024755141", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840428", "udi_public": "08714729840428", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Difficult to Remove", "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200701", "sequence_number_treatment": [ "7 FR TRAPLINER GUIDE CATHETER" ], "sequence_number_outcome": [ "" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200701", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10219873", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200611", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "197201180", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "197201181", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.50X38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN PULLING OUT THE STENT THROUGH A 7 FR NON-BSC GUIDE EXTENSION CATHETER, THE STENT WAS STUCK. THE DEVICES WERE PULLED OUT AND THE STENT WAS FOUND BENDED OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT OF THE SAME SIZE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-08246", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200707", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200608", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200707", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200707", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211028", "model_number": "10600", "catalog_number": "10600", "lot_number": "0024713078", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200629", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729839972", "udi_public": "08714729839972", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/28/2020", "manufacturer_contact_country": "", "date_changed": "20230724", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200707", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200820", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10242493", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200615", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "197938850", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "197938851", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.50 X 8MM SYNERGY II DRUG-ELUTING STENT SHAFT SNAPPED IN HALF WHILE BEING INTRODUCED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." }, { "mdr_text_key": "319603217", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.50 X 8MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH THE STENT. THERE WERE NO SIGNS OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKER BANDS. THE CRIMPED STENT OUTER DIAMETER WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON WAS REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND A BREAK 910MM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. MULTIPLE HYPOTUBE KINKS WERE ALSO NOTED. A VISUAL EXAMINATION OF THE SHAFT POLYMER EXTRUSION FOUND NO ISSUES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319603218", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.50 X 8MM SYNERGY II DRUG-ELUTING STENT SHAFT SNAPPED IN HALF WHILE BEING INTRODUCED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/21/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08263", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200708", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200615", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200708", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191023", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200708", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211022", "model_number": "10601", "catalog_number": "10601", "lot_number": "0024687499", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840022", "udi_public": "08714729840022", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200708", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200708", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10246484", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200615", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "197986417", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "197986418", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 2.25 X 12 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHILE ADVANCING THE STENT DELIVERY SYSTEM IN THE GUIDE CATHETER, THE SHAFT BROKE IN HALF MID-WAY. BOTH PIECES OF THE DELIVERY SYSTEM WAS RETRIEVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08290", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200708", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200116", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RQ", "manufacturer_contact_area_code": "763", "date_added": "20200708", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190703", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200708", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210702", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024095364", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840404", "udi_public": "08714729840404", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Fracture" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200708", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200708", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10247855", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200616", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "198027565", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "198027566", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VERY CALCIFIED ARTERY. FOLLOWING PRE-DILATATION WITH A WOLVERINE CUTTING BALLOON, A 2.75 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, DURING PROCEDURE, THE STENT BROKE. NO FURTHER INFORMATION IS AVAILABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08283", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200709", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RQ", "manufacturer_contact_area_code": "763", "date_added": "20200709", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190703", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200709", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210702", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024095364", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840404", "udi_public": "08714729840404", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200709", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200709", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10255811", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200616", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "198291240", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "198291241", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THEY REMOVED THE DEVICE, IT WAS NOTICED THAT THE PROXIMAL LINE OF THE STRUTS WERE LIFTED UP. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09224", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200713", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200713", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200713", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220209", "model_number": "10603", "catalog_number": "10603", "lot_number": "0025220619", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840176", "udi_public": "08714729840176", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/06/2020", "manufacturer_contact_country": "", "date_changed": "20230725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200713", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200828", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10264632", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200616", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319703629", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT MOVEMENT ON BALLOON OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT HAD A SECTION NEAR ONE END OF THE BALLOON THAT WAS OFF THE BALLOON AND HAD A SEGMENT STICKING UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE STENT WAS STICKING UP AFTER WITHDRAWAL FROM THE PATIENT." }, { "mdr_text_key": "319703630", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. B5 - DESCRIBE EVENT OR PROBLEM UPDATED." }, { "mdr_text_key": "198539429", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "198539430", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT MOVEMENT ON BALLOON OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT HAD A SECTION NEAR ONE END OF THE BALLOON THAT WAS OFF THE BALLOON AND HAD A SEGMENT STICKING UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09339", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200714", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200707", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200714", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200714", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211006", "model_number": "10601", "catalog_number": "10601", "lot_number": "0024606454", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840053", "udi_public": "08714729840053", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/25/2020", "manufacturer_contact_country": "", "date_changed": "20230718", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200714", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200828", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10274135", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200709", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319254974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATED BY MFR.: SYNERGY II US MR 3.00 X 12 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION (VISUAL AND VIA SCOPE) OF THE CRIMPED STENT FOUND STENT DAMAGE. STENT STRUTS FROM THE DISTAL REGION OF THE STENT WERE NOTED TO BE LIFTED FROM THEIR CRIMPED POSITION AND PULLED PROXIMALLY. THE UNDAMAGED CRIMPED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319254975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 12 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS FOUND OUT THAT THE STENT EDGE WAS DEFORMED ON BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "198875278", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "198875279", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 12 SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS FOUND OUT THAT THE STENT EDGE WAS DEFORMED ON BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08987", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200716", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200630", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200716", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20200127", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200716", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220126", "model_number": "10602", "catalog_number": "10602", "lot_number": "0025171790", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840121", "udi_public": "08714729840121", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200716", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200716", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10283678", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200630", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199105722", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "199105723", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED CORONARY ARTERY. A 3.50 X 16 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, PRIOR TO PLACEMENT INSIDE THE VESSEL, IT WAS NOTED THAT THE STENT DISLODGED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-08981", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200717", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200717", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190819", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200717", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210818", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024339499", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840190", "udi_public": "08714729840190", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Rupture" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200717", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200717", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10290001", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200701", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199292567", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "199292568", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 76% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. AFTER IVUS WAS PERFORMED, THE PHYSICIAN ADVANCED DIRECTLY A 4.00 X 20MM SYNERGY DRUG-ELUTING STENT WITHOUT PRE-DILATING THE LESION. HOWEVER, DURING PROCEDURE THE BALLOON WAS NOT EXPANDING AS THE ATMOSPHERIC PRESSURE WAS GOING UP. IT WAS NOTED THEN THAT DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS THE BALLOON RUPTURED. THE STENT WAS PLACED BY USING A NON-COMPLIANT BALLOON TO FULLY EXPAND THE DEVICE AND MAKE SURE IT WAS WELL APPOSED. THE BALLOON THAT RUPTURED WAS COMPLETELY WITHDRAWN IN A FULLY DEFLATED STATE. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-08989", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200717", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200630", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200717", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200717", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210909", "model_number": "10602", "catalog_number": "10602", "lot_number": "0024442846", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840138", "udi_public": "08714729840138", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Deflation Problem", "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/20/2020", "manufacturer_contact_country": "", "date_changed": "20230725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200717", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200915", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10290274", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200701", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319703259", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND DIFFICULTY REMOVAL WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 16 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. AFTER DEPLOYMENT THE BALLOON APPEARED TO DEFLATE. HOWEVER, THE STENT BALLOON WAS UNABLE TO BE REMOVED BACK INTO THE GUIDE. THE PHYSICIAN SUCKED BACK ON THE INDEFLATOR MULTIPLE TIMES TO GET THE BALLOON DEFLATED BUT UNABLE TO GET THE BALLOON TO DEFLATE COMPLETELY. THE DEVICES WERE THEN REMOVED TOGETHER IN ORDER TO REMOVE THE BALLOON FROM THE PATIENT'S BODY. THE PHYSICIAN THEN ENGAGED THE CORONARY AGAIN AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "319703260", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 4.00 X 16MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS WITHOUT THE STENT. A VISUAL EXAMINATION OF THE STENT FOUND THAT THE STENT WAS NOT RETURNED AS IT WAS POSITIONED AND DEPLOYED SUCCESSFULLY AT THE LESION SITE. THE BALLOON CONES WERE REVIEWED, AND SIGNS OF POSITIVE PRESSURE APPLIED TO THE CONES WERE NOTED AS ITS WINGS WERE RELAXED AND NOT TIGHTLY FOLDED. THE DISTAL SECTION OF THE BALLOON IS SLIGHTLY BUNCHED. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND BUNCHING/ACCORDION OF THE DISTAL INNER 6.5CM PROXIMAL TO THE DISTAL END OF THE TIP. THE DEVICE WAS PLACED IN WATER BATH OVERNIGHT FOR SOAKING PRE-INFLATION TEST. THE DEVICE WAS LOADED ONTO A 0.014'' GUIDE WIRE AND LOADED INTO A TEST GUIDE CATHETER WITHOUT ISSUE. THE BALLOON WAS INFLATED USING A PRESSURE OF 16 ATM WITH NO ISSUES. VACUUM WAS PULLED AND THE BALLOON DEFLATED IN 9 SECONDS WITH NO ISSUES. THE DEVICE WAS WITHDRAWN INTO GUIDE CATHETER AND REMOVED WITHOUT ISSUE. THE ENCORE INFLATION DEVICE WAS VERIFIED BEFORE AND AFTER USE UP TO 16 ATM USING DRUCK GAUGE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "199299551", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "199299552", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND DIFFICULTY REMOVAL WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 16 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. AFTER DEPLOYMENT THE BALLOON APPEARED TO DEFLATE. HOWEVER, THE STENT BALLOON WAS UNABLE TO BE REMOVED BACK INTO THE GUIDE. THE PHYSICIAN SUCKED BACK ON THE INDEFLATOR MULTIPLE TIMES TO GET THE BALLOON DEFLATED BUT UNABLE TO GET THE BALLOON TO DEFLATE COMPLETELY. THE DEVICES WERE THEN REMOVED TOGETHER IN ORDER TO REMOVE THE BALLOON FROM THE PATIENT'S BODY. THE PHYSICIAN THEN ENGAGED THE CORONARY AGAIN AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/15/2020" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05978", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296006", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199499373", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199499374", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED 3X18MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS THAT SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05983", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121202", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296212", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199539101", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199539102", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED 3.5X18MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 1 DAY LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05991", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130307", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296272", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199550261", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199550262", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. AN UNSPECIFIED 3X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 96 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06040", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200721", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200721", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200721", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200721", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10301430", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199690480", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: DATES ARE ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199690481", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. AN UNSPECIFIED 3.5X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS THAT SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06041", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200721", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121214", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200721", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200721", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200721", "sequence_number_treatment": [ "3.5X12MM ABSORB" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10301894", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199704936", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199704937", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. TWO UNSPECIFIED 3.5X12MM ABSORB BIODEGRADABLE SCAFFOLDS WERE IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 13 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09087", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200721", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200721", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200721", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210827", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024361060", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840435", "udi_public": "08714729840435", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Deflation Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/22/2020", "manufacturer_contact_country": "", "date_changed": "20230731", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200721", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "42 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200813", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10305942", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200702", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320082904", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. BSC AWARE DATE CORRECTED FROM 07/02/2020 TO 07/03/2020." }, { "mdr_text_key": "320082905", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED AND PLACED. HOWEVER, UPON REMOVAL, THE BALLOON WOULD NOT RE-WRAP AND WOULD NOT GO INTO THE GUIDE CATHETER. THE PHYSICIAN USED A NEW GUIDE CATHETER AND THEN REMOVED ALL DEVICES AS A WHOLE. THE BALLOON WAS REMOVED IN A DEFLATED STATE AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE CLACIFIED LESION WAS PRE-TREATED WITH CORONARY ORBITAL ATHERECTOMY SYSTEM AND A NON-COMPLIANT BALLOON BEFORE STENTING. THE BALLOON WAS INFLATED ONCE AT 20 ATMOSPHERES FOR 9 SECONDS AFTER INITIAL STENT DEPLOYMENT." }, { "mdr_text_key": "199856936", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "199856937", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED AND PLACED. HOWEVER, UPON REMOVAL, THE BALLOON WOULD NOT RE-WRAP AND WOULD NOT GO INTO THE GUIDE CATHETER. THE PHYSICIAN USED A NEW GUIDE CATHETER AND THEN REMOVED ALL DEVICES AS A WHOLE. THE BALLOON WAS REMOVED IN A DEFLATED STATE AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/13/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09188", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200721", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200721", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200721", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220126", "model_number": "10602", "catalog_number": "10602", "lot_number": "0025167160", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840114", "udi_public": "08714729840114", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Entrapment of Device" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/25/2020", "manufacturer_contact_country": "", "date_changed": "20230517", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200721", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200921", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10306033", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200702", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199856760", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: USED THE 1ST DAY OF THE MONTH OF THE BSC AWARE DATE AS NO EVENT DATE WAS PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "199856761", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT COULD NOT BE REMOVED FROM THE WIRE AND HAD TO PULL EVERYTHING OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE AND STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE." }, { "mdr_text_key": "315379552", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT COULD NOT BE REMOVED FROM THE WIRE AND HAD TO PULL EVERYTHING OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE AND STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE." }, { "mdr_text_key": "315379553", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B3) DATE OF EVENT: USED THE 1ST DAY OF THE MONTH OF THE BSC AWARE DATE AS NO EVENT DATE WAS PROVIDED. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 3.00 X 16MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS WITH A GUIDEWIRE INSERTED INTO THE EXCHANGE PORT, BUT NOT EXITING AT THE TIP, OF THE DEVICE. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. THE CRIMPED STENT OUTER DIAMETER WAS MEASURED USING SNAP GAUGE AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. THE DEVICE WAS RETURNED WITH THE FLOPPY END OF A GUIDEWIRE STUCK IN THE EXCHANGE PORT OF THE DEVICE. THE DEVICE AND ATTACHED GUIDEWIRE WAS SOAKED IN A BATH AT 37 DEGREES. ONCE REMOVED FROM THE BATH THE GUIDEWIRE WAS REMOVED WITHOUT ISSUE FROM THE DEVICE AND WAS ABLE TO BE RE-INSERTED THROUGH THE DISTAL TIP AND EXITED AT THE EXCHANGE PORT WITH NO ISSUES. THE GUIDEWIRE DIAMETER WAS CHECKED AND THE RECORDED DIAMETER WAS BELOW THE MAXIMUM VALUE. NO ISSUES WERE NOTED WITH THE GUIDEWIRE. NO ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/21/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09097", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200722", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200722", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210827", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024361060", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840435", "udi_public": "08714729840435", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/24/2020", "manufacturer_contact_country": "", "date_changed": "20230720", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200917", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10310305", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200702", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319422270", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. POST STENT DEPLOYMENT, THE BALLOON DEFLATED BUT WOULD NOT RE-WRAP AND BECAME STUCK AT THE DISTAL END OF THE CATHETER. THE ENTIRE SYSTEM HAD TO BE TAKEN OUT TO REMOVE THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "319422271", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATED BY MFR.: SYNERGY II US MR 4.00 X 38MM STENT DELIVERY SYSTEM, CATHETER WAS RETURNED FOR ANALYSIS INSIDE A GUIDECATHETER WITH GUIDEWIRE INSERTED. THE DEVICE WAS REMOVED WITHOUT ISSUES FROM GUIDE CATHETER BY PULLING IT PROXIMALLY. THE GUIDEWIRE WAS REMOVED THOUGH THE DISTAL TIP OF THE DEVICE WITHOUT ISSUE. THE DEVICE WAS RETURNED WITHOUT THE STENT. THE BALLOON WAS REVIEWED, AND ISSUES WERE NOTED. NO STENT WAS ATTACHED TO THE BALLOON AND THE BALLOON APPEARED TO HAVE HAD POSITIVE PRESSURE APPLIED (INFLATED/DEFLATED) AND IS BUNCHED IN THE DISTAL REGION. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. THE ENCORE INFLATION DEVICE WAS ATTACHED TO SYNERGY DEVICE AND THE BALLOON WAS INFLATED TO 16 ATM AND THE BALLOON WAS SUCCESSFULLY EXPANDED FOR 25 SECONDS. A VACUUM WAS PULLED USING THE ENCORE DEVICE AND THE BALLOON DEFLATED FULLY AFTER 18 SECONDS. THE ENCORE DEVICE WAS VERIFIED BEFORE AND AFTER THE PROCEDURE USING A DRUCK GAUGE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "199935339", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "199935340", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED TO TREAT THE LESION. POST STENT DEPLOYMENT, THE BALLOON DEFLATED BUT WOULD NOT RE-WRAP AND BECAME STUCK AT THE DISTAL END OF THE CATHETER. THE ENTIRE SYSTEM HAD TO BE TAKEN OUT TO REMOVE THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/17/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-08964", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200722", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200722", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210909", "model_number": "10604", "catalog_number": "10604", "lot_number": "0024455130", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840251", "udi_public": "08714729840251", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Deflation Problem", "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/24/2020", "manufacturer_contact_country": "", "date_changed": "20230724", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200722", "sequence_number_treatment": [ "INFLATION DEVICE: MERIT.", " INFLATION DEVICE: MERIT." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200918", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10310521", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200702", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199989994", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "199989995", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER PLACING THE STENT, IT WAS NOTED THAT THE STENT BALLOON KEPT ON GETTING CAUGHT ON THE GUIDE WHEN ATTEMPTING TO BE REMOVED AND THE BALLOON WOULD NOT DEFLATE PROPERLY. THE PHYSICIAN THEN REMOVED ALL THE DEVICES IN ORDER TO REMOVED THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS FINE." }, { "mdr_text_key": "319610252", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SYNERGY II US MR 4.00 X 24MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS WITHOUT THE STENT. A VISUAL EXAMINATION OF THE STENT FOUND THAT THE STENT WAS NOT RETURNED AS IT WAS POSITIONED AND DEPLOYED SUCCESSFULLY AT THE LESION SITE. THE BALLOON CONES WERE REVIEWED, AND SIGNS OF POSITIVE PRESSURE APPLIED TO THE CONES WERE NOTED AS ITS WINGS WERE RELAXED AND NOT TIGHTLY FOLDED. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES. THE DEVICE WAS PLACED IN WATER BATH OVERNIGHT FOR SOAKING PRE-INFLATION TEST. THE DEVICE WAS LOADED ONTO A GUIDE WIRE AND LOADED INTO A TEST GUIDE CATHETER WITHOUT ISSUE. THE BALLOON WAS INFLATED USING A PRESSURE OF 16 ATM WITH NO ISSUES. VACUUM WAS PULLED AND THE BALLOON DEFLATED IN 08 SECONDS WITH NO ISSUES. THE DEVICE WAS WITHDRAWN INTO A GUIDE CATHETER AND REMOVED WITHOUT ISSUE. THE ENCORE INFLATION DEVICE WAS VERIFIED BEFORE AND AFTER USE UP TO 16 ATM USING A DRUCK GAUGE. NO ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319610253", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DEFLATION FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER PLACING THE STENT, IT WAS NOTED THAT THE STENT BALLOON WAS GETTING CAUGHT ON THE GUIDE WHEN ATTEMPTING TO BE REMOVED AND THE BALLOON WOULD NOT DEFLATE PROPERLY. THE PHYSICIAN THEN REMOVED ALL THE DEVICES IN ORDER TO REMOVE THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS FINE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/18/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-09741", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200723", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200723", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191029", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200723", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211028", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024727595", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840398", "udi_public": "08714729840398", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200723", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200722", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10312271", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200712", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "200012652", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: USED THE 1ST DAY OF THE MONTH OF THE BSC AWARE DATE SINCE EVENT DATE WAS NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "200012653", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 38MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN IT WAS REMOVED FOR PREDILATION, THE STRUTS WERE DEFORMED. NO FURTHER INFORMATION AVAILABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09086", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200723", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200723", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200723", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211015", "model_number": "10607", "catalog_number": "10607", "lot_number": "0024666504", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840435", "udi_public": "08714729840435", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/25/2020", "manufacturer_contact_country": "", "date_changed": "20230720", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200723", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200918", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10313884", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200702", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319380311", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATED BY MFR.: SYNERGY II US MR 4.00 X 38MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS IN THE MOST PROXIMAL STRUT ROW WERE LIFTED AND PULLED IN A DISTAL DIRECTION. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT IS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND ISSUES WITH BUNCHING NOTED IN THE DISTAL INNER EXTRUSION 80MM PROXIMAL TO DISTAL END OF TIP. A 0.014\" GUIDEWIRE, VERIFIED AND LOADED SUCCESSFULLY THROUGH THE DISTAL END OF THE TIP TO A DEPTH OF 80MM WHERE IT MET AN OBSTRUCTION IN THE FORM OF POLYMER EXTRUSION BUNCHING. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319380312", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED VESSEL. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE BUT WAS UNABLE TO ADVANCE INTO LESION EVEN AFTER ROTABLATION WITH A 1.75MM BURR. THE STENT STRUTS WERE DAMAGED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "200047325", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "200047326", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED VESSEL. A 4.00 X 38 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE BUT WAS UNABLE TO ADVANCE INTO LESION EVEN AFTER ROTABLATION WITH A 1.75MM BURR. THE STENT STRUTS WERE DAMAGED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/18/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2134265-2020-09196", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200724", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200724", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200724", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "10601", "catalog_number": "10601", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200727", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/25/2020", "manufacturer_contact_country": "", "date_changed": "20230801", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200724", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200918", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10323607", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200706", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320127475", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED IN A KISSING STENT FASHION. THE STENT WAS DEPLOYED WELL BUT SOMEHOW BECAME STUCK UNDERNEATH THE OTHER STENT THAT WAS ALREADY PLACED AND GOT PINNED UP AGAINST A STENT STRUT AND SNAPPED OFF THE HYPOTUBE OF THE STENT BALLOON. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS THEN ADVANCED, BUT WAS ALSO PINNED WITHIN THE STENT STRUT AND SNAPPED OFF AS WELL. THEY USED A SNARE TO REMOVE THE DEVICE AND PATIENT WAS STABLE ENOUGH TO MOVE TO INTENSIVE CARE UNIT (ICU)." }, { "mdr_text_key": "320127476", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.50 X 12MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. PARTIAL DEVICE (1319MM IN LENGTH) FROM PROXIMAL TIP OF MANIFOLD TO GUIDEWIRE PORT WITH EXPOSED CORE WIRE RETURNED. DISTAL SECTION (INCLUDING PORTION OF DISTAL SHAFT, BALLOON, STENT AND TIP) NOT RETURNED. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND A HYPOTUBE LASERCUT REGION EXPOSED WITH OUTER LUMEN COATING REMOVED 25 MM PROXIMAL TO GUIDEWIRE PORT (1226 DISTAL TO PROXIMAL END OF MANIFOLD) AND MULTIPLE KINKS ALONG THE LENGTH OF THE SHAFT. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION IDENTIFIED A BREAK IN THE POLYMER EXTRUSION REGION (WITHIN THE TROUGH/WIRE EXCHANGE PORT WITH EXPOSED COREWIRE) 1264MM DISTAL TO TIP OF THE MANIFOLD. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "200391647", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "200391648", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED IN A KISSING STENT FASHION. THE STENT WAS DEPLOYED WELL BUT SOMEHOW BECAME STUCK UNDERNEATH THE OTHER STENT THAT WAS ALREADY PLACED AND GOT PINNED UP AGAINST A STENT STRUT AND SNAPPED OFF THE HYPOTUBE OF THE STENT BALLOON. A 3.50MM X 12MM NC EMERGE BALLOON CATHETER WAS THEN ADVANCED, BUT WAS ALSO PINNED WITHIN THE STENT STRUT AND SNAPPED OFF AS WELL. THEY USED A SNARE TO REMOVE THE DEVICE AND PATIENT WAS STABLE ENOUGH TO MOVE TO INTENSIVE CARE UNIT (ICU)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/18/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-09177", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200727", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200706", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RQ", "manufacturer_contact_area_code": "763", "date_added": "20200727", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190501", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200727", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210430", "model_number": "10606", "catalog_number": "10606", "lot_number": "0023806200", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840367", "udi_public": "08714729840367", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Fracture", "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200727", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10328842", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200706", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "200607009", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "200607010", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DISLODGEMENT AND SHAFT BREAK OCCURRED. A 3.50 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT THE STENT DELIVERY SYSTEM BROKE WHEN TRYING TO CROSS THE LESION. WHEN THEY PULLED IT OUT FROM THE GUIDE CATHETER, THE STENT FELL OFF THE BALLOON AND GOT LOST. NO PATIENT COMPLICATIONS WERE REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-10023", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200728", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200301", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RQ", "manufacturer_contact_area_code": "763", "date_added": "20200728", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190724", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200728", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210723", "model_number": "10604", "catalog_number": "10604", "lot_number": "0024177119", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200615", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840251", "udi_public": "08714729840251", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Failure to Advance" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200728", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10331726", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200707", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "200596036", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DATE OF EVENT: USED (B)(6) 2020 AS THE CORRECT DATE WAS NOT PROVIDED. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 4.00 X 24MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. A STENT STRUT FROM THE MOST PROXIMAL STRUT ROW WAS LIFTED AND PULLED DISTALLY. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "200596037", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-JUL-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CALCIFIED CORONARY ARTERY. A 4.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-10058", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200728", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200317", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RQ", "manufacturer_contact_area_code": "763", "date_added": "20200728", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190710", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200728", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210709", "model_number": "10602", "catalog_number": "10602", "lot_number": "0024133761", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200615", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840091", "udi_public": "08714729840091", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200728", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "78 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10333869", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200707", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "200656554", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.50 X 16MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH THE STENT. THERE WERE NO SIGNS OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKER BANDS. THE CRIMPED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE IDENTIFIED A BREAK 238MM DISTAL FROM THE DISTAL END OF THE STRAIN RELIEF. MULTIPLE HYPOTUBE KINKS WERE ALSO IDENTIFIED. AN EXAMINATION OF THE SHAFT POLYMER EXTRUSION FOUND NO ISSUES. AN EXAMINATION OF THE TIP IDENTIFIED NO TIP DAMAGE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "200656555", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07JUL-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE DETACHED/SEPARATED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-10151", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200729", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200301", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RQ", "manufacturer_contact_area_code": "763", "date_added": "20200729", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190724", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200729", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210723", "model_number": "10604", "catalog_number": "10604", "lot_number": "0024177119", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200616", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840251", "udi_public": "08714729840251", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Failure to Advance" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200729", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10339668", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200708", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "200843690", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. 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THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED, BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, THE STENT STRUTS WERE NOTED TO BE RAISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." }, { "mdr_text_key": "319927720", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B3) DATE OF EVENT: USED THE 1ST DAY OF THE MONTH OF THE BSC AWARE DATE AS NO EVENT DATE WAS PROVIDED. DEVICE EVALUATED BY MFR: SYNERGY II US MR 3.00 X 32MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS IN THE MID SECTION OF THE STENT WERE LIFTED AND PULLED IN A DISTAL DIRECTION. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED USING SNAP GAUGE AND THE RESULT IS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED SIGNS OF DISTAL TIP DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "201398075", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DATE OF EVENT: USED THE 1ST DAY OF THE MONTH OF THE BSC AWARE DATE AS NO EVENT DATE WAS PROVIDED." }, { "mdr_text_key": "201398076", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED, BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, THE STENT STRUTS WERE NOTED TO BE RAISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/04/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-09350", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200731", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200504", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200731", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20191111", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200731", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211110", "model_number": "10602", "catalog_number": "10602", "lot_number": "0024800795", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200525", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840107", "udi_public": "08714729840107", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Inflation Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200731", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200731", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10350005", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200709", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201530939", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.75 X 16 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS WITH THE CUSTOMER GUIDEWIRE INSERTED. A VISUAL AND MICROSCOPIC EVALUATION OF THE STENT STRUTS FOUND THAT THE STENT WAS DAMAGED ON THE MOST PROXIMAL STENT STRUT ROW WITH ONE OF THE STRUTS SLIGHTLY MOVED OUT OF PLACE. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED USING SNAP GAUGE AND THE RESULT WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A RED/BROWN BLOOD LIKE SUBSTANCE WAS NOTED IN THE DISTAL BALLOON CONE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED SIGNS OF DAMAGE ON THE DISTAL END OF THE TIP. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE HYPOTUBE KINKS ALONG SEVERAL LOCATIONS OF THE HYPOTUBE SHAFT. A RED/BROWN BLOOD LIKE SUBSTANCE WAS NOTED IN THE MANIFOLD HUB. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION FOUND A TWIST IN THE SHAFT POLYMER EXTRUSION AT THE GUIDEWIRE EXCHANGE PORT. FUNCTIONAL TESTING OF THE DEVICE WAS RECEIVED WITH THE CUSTOMER GUIDEWIRE INSERTED, AND NOTED TO BE EASILY MOVED THROUGH THE LUMEN. AN INFLATION/DEFLATION TEST WAS ATTEMPTED USING AN ENCORE DEVICE. GRADUAL LOSS OF PRESSURE IN THE INFLATION DEVICE WAS NOTED AND WAS DUE TO A LEAK ON THE PROXIMAL BALLOON CONE. A FURTHER INSPECTION OF THE PROXIMAL BALLOON CONE UNDER MICROSCOPE, IDENTIFIED A PINHOLE IN THE BALLOON MATERIAL AT THE LEAK SITE, 0.5MM DISTAL OF THE DISTAL EDGE OF PROXIMAL MARKERBAND. EXAMINATION OF THE BALLOON MATERIAL AROUND THE PINHOLE IDENTIFIED SOME RAISED MATERIAL, HOWEVER IT WAS NOTED THAT THIS WAS IDENTIFIED AFTER INFLATION ATTEMPTS. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "201530940", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09-JUL-2020. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. PRE-DILATION WAS PERFORMED WITH A 2.5 X 12 EMERGE AND A 2.5 X 10 WOLVERINE BALLOON CATHETERS. A 2.75 X 16 SYNERGY DRUG-ELUTING STENT WAS PLACED OVER THE WIRE INTO THE LESION. THE STENT WAS CONNECTED TO THE INFLATION DEVICE AND INFLATED TO NOMINAL PRESSURE, BUT THE STENT BALLOON DID NOT INFLATE, THE INFLATION DEVICE DID NOT HOLD A PRESSURE, AND THE ATMOSPHERES KEPT DROPPING AS INFLATING. THERE WAS BLOOD BACKING INTO THE CONNECTED DEFLATION DEVICE. THE INFLATION DEVICE WAS DISCONNECTED, AND THE STENT DELIVERY SYSTEM AND WIRE WERE REMOVED AT THE SAME TIME. ONCE REMOVED, THE STENT WAS INTACT ON THE BALLOON. THE LCX WAS REWIRED WITH A NEW WIRE AND INSERTED A NEW 2.75 X 16 SYNERGY STENT AND WAS DEPLOYED WITH THE SAME INFLATION DEVICE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE AND STENT DAMAGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09583", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200803", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200702", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200803", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200803", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211118", "model_number": "10601", "catalog_number": "10601", "lot_number": "0024835573", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200805", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840053", "udi_public": "08714729840053", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/03/2020", "manufacturer_contact_country": "", "date_changed": "20230907", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200803", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200909", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10356769", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200713", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319985120", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATED BY MFR: SYNERGY II US MR 3.00 X 12MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS IN THE DISTAL SECTION OF THE STENT WERE LIFTED AND PULLED DISTALLY, ALSO A STENT STRUT IN THE PROXIMAL SECTION OF THE STENT WAS LIFTED FROM ITS CRIMPED POSITION. THE UNDAMAGED STENT OUTER DIAMETER WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319985121", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING REMOVAL IT WAS NOTICED THAT THE STENT STRUTS WERE DISTORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS OKAY." }, { "mdr_text_key": "201583585", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "201583586", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING REMOVAL IT WAS NOTICED THAT THE STENT STRUTS WERE DISTORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS OKAY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/09/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-10376", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200803", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200520", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RQ", "manufacturer_contact_area_code": "763", "date_added": "20200803", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190515", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200803", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210514", "model_number": "10606", "catalog_number": "10606", "lot_number": "0023843865", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200616", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840343", "udi_public": "08714729840343", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200803", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10357036", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200713", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201401392", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.75 X 32MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKERBANDS. THE CRIMPED STENT OUTER DIAMETER WAS MEASURED USING SNAP GAUGE AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND A BREAK SITUATED AT 22.1CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. ALSO, MULTIPLE KINKS LOCATED AT DIFFERENT PLACES ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "201401393", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13-JUL-2020. IT WAS REPORTED THAT FAILURE TO CROSS LESION OCCURRED. A 2.75 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE THE STENT DID NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-10390", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200803", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200317", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "RQ", "manufacturer_contact_area_code": "763", "date_added": "20200803", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190423", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200803", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210422", "model_number": "10605", "catalog_number": "10605", "lot_number": "0023704654", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200616", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840268", "udi_public": "08714729840268", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Failure to Advance" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200915", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200803", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "78 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10357727", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200714", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201581354", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE EVALUATED BY MFR SYNERGY OUS MR 2.25 X 28 MM STENT DELIVERY SYSTEM CATHETER WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS FROM THE DISTAL REGION OF THE STENT WERE SLIGHTLY MOVED OUT OF PLACE. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT IS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED SIGNS OF DISTAL TIP DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. NO OTHER ISSUES." }, { "mdr_text_key": "201581355", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-JUL-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 28MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2134265-2020-09985", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200804", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200715", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200804", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200804", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211217", "model_number": "10606", "catalog_number": "10606", "lot_number": "0024987272", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200811", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840367", "udi_public": "08714729840367", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Damaged by Another Device" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/13/2020;09/09/2020", "manufacturer_contact_country": "", "date_changed": "20230808", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200804", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20201005", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10362794", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200715", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320592208", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A SYNERGY II 3.00 X 32MM STENT (FINISHED GOODS BATCH #24987272) WAS RETURNED FOR ANALYSIS. THE 3.00 X 32MM STENT WAS ATTACHED TO THE DISTAL END OF THE BALLOON OF A 3.00 X 12MM SYNERGY II STENT DELIVERY SYSTEM (SDS (FINISHED GOODS BATCH #25042148). A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. THE ENTIRE STENT WAS PULLED AND STRETCHED DISTALLY SO THAT ONLY THE MOST PROXIMAL END OF THE STENT WAS ATTACHED TO THE DISTAL END OF THE BALLOON. IT WAS NOT POSSIBLE TO OBTAIN A UNDAMAGED OUTER DIAMETER (OD) FOR THIS STENT. THE SDS FOR THE 3.00 X 32MM STENT WAS NOT RETURNED FOR ANALYSIS. (THE 3.00 X 12MM STENT HAD BEEN SUCCESSFULLY DEPLOYED INSIDE THE PATIENT.)" }, { "mdr_text_key": "320592209", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DEVICE WAS EXPLANTED AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 12MM SYNERGY II DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE DISTAL LAD AND A 3.50 X 32MM SYNERGY II DES WAS IMPLANTED PROXIMAL LAD. HOWEVER, DURING CATHETER REMOVAL OF THE DISTALLY IMPLANTED STENT, IT CAUGHT THE PROXIMALLY IMPLANTED STENT. THE PROXIMAL STENT WAS THEN PULLED OUT OF THE PATIENT'S BODY AND WAS NOTED THROUGH THE IMAGES THAT STENT DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED." }, { "mdr_text_key": "315424746", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DEVICE WAS EXPLANTED AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 12MM SYNERGY II DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE DISTAL LAD AND A 3.50 X 32MM SYNERGY II DES WAS IMPLANTED PROXIMAL LAD. HOWEVER, DURING CATHETER REMOVAL OF THE DISTALLY IMPLANTED STENT, IT CAUGHT THE PROXIMALLY IMPLANTED STENT. THE PROXIMAL STENT WAS THEN PULLED OUT OF THE PATIENT'S BODY AND WAS NOTED THROUGH THE IMAGES THAT STENT DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MILDLY TORTUOUS AND MILDLY CALCIFIED." }, { "mdr_text_key": "315424747", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B5 DESCRIBE EVENT OR PROBLEM UPDATED." }, { "mdr_text_key": "201558935", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DEVICE WAS EXPLANTED AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00 X 12MM SYNERGY II DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE DISTAL LAD AND A 3.50 X 32MM SYNERGY II DES WAS IMPLANTED PROXIMAL LAD. HOWEVER, DURING CATHETER REMOVAL OF THE DISTALLY IMPLANTED STENT, IT CAUGHT THE PROXIMALLY IMPLANTED STENT. THE PROXIMAL STENT WAS THEN PULLED OUT OF THE PATIENT'S BODY AND WAS NOTED THROUGH THE IMAGES THAT STENT DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/07/2020;10/05/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-09740", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200804", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200715", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200804", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190729", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200804", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210728", "model_number": "10602", "catalog_number": "10602", "lot_number": "0024224833", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840091", "udi_public": "08714729840091", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Difficult to Advance" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200915", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200804", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200804", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10362996", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200715", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201734917", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DIAGONAL BRANCH. AFTER PRE-DILATION WAS PERFORMED WITH A 2X12MM EMERGE BALLOON CATHETER. A 2.25 X 12 AND 2.50 X 16 SYNERGY DRUG-ELUTING STENTS WERE SELECTED FOR USE; BUT, DURING INSERTION, THE STENTS LOSE WIRE ACCESS. THE STENTS WERE COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PHYSICIAN DECIDED NOT TO PROCEED AND ABORTED THE PROCEDURE. 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VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE 33MM IN LENGTH, ECCENTRIC, DE NOVO TARGET LESION CONTAINED A <45 DEGREES BEND AND WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. AFTER PRE-DILATION WAS PERFORMED, 4.00 X 38 AND 2.50 X 20 SYNERGY DRUG-ELUTING STENTS WERE ADVANCED BUT FAILED TO CROSS THE LESION. THE STENTS WERE REMOVED FROM THE PATIENT'S BODY WITH NO COMPLICATIONS. SUBSEQUENTLY, TWO SYNERGY STENTS WERE IMPLANTED OVERLAPPING EACH OTHER. AFTER POST DILATATION, AN EDGE DISSECTION WAS NOTICED WHICH RESULTED IN NO REFLOW AND CAUSED PATIENT DETERIORATION. ON THE FOLLOWING DAY, A PROCEDURE WAS PERFORMED USING A CUTTING BALLOON CATHETER AND THE PATIENT RECOVERED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09895", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200805", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200716", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200805", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200805", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220310", "model_number": "10604", "catalog_number": "10604", "lot_number": "0025411184", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200805", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840237", "udi_public": "08714729840237", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/02/2020", "manufacturer_contact_country": "", "date_changed": "20230728", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200805", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200907", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10367124", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200716", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201686863", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE SHAFT FRACTURED WHEN STARTED TO MOUNT ON WIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE." }, { "mdr_text_key": "319948246", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 24 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE SHAFT FRACTURED WHEN STARTED TO MOUNT ON WIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE." }, { "mdr_text_key": "319948247", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATED BY MFR: SYNERGY II US MR 3.00 X 24MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUT IN THE DISTAL SECTION OF THE STENT WAS LIFTED FROM ITS CRIMPED POSITION. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED USING SNAP GAUGE AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/07/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-10589", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200805", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200729", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200805", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190606", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200805", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210605", "model_number": "10605", "catalog_number": "10605", "lot_number": "0023945917", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840305", "udi_public": "08714729840305", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200915", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200805", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200805", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10371012", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200730", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201847617", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "201847618", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 28MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING AND UPON INSPECTION WHILE FLUSHING, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. A NEW STENT WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09721", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200806", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200701", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200806", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200806", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211009", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024609759", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200820", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840176", "udi_public": "08714729840176", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/10/2020", "manufacturer_contact_country": "", "date_changed": "20230804", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200806", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20201002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10375040", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200715", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201934858", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: DATE WAS NOT PROVIDED, USED (B)(6) 2020 AS DATE OF EVENT." }, { "mdr_text_key": "201934859", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS THEN NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "320376192", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 20 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS THEN NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "320376193", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3 DATE OF EVENT: DATE WAS NOT PROVIDED, USED (B)(6) 2020 AS DATE OF EVENT. DEVICE EVALUATION BY MFR.: SYNERGY II US MR 3.00 X 20MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS FROM THE DISTAL END OF THE STENT WERE LIFTED AND PULLED DISTALLY. THE UNDAMAGED STENT OUTER DIAMETER WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED SIGNS OF DISTAL TIP DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND TWO HYPOTUBE KINKS AT 1MM AND 740MM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/02/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-10710", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200807", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200728", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200807", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20200102", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200807", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220101", "model_number": "10601", "catalog_number": "10601", "lot_number": "0025000498", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840039", "udi_public": "08714729840039", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200807", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200807", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10378137", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200728", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "202002712", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "202002713", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50 X 12MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT STRUT WAS OUT. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-09720", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200807", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200807", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200807", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211006", "model_number": "10603", "catalog_number": "10603", "lot_number": "0024612501", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200811", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Difficult to Advance", "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/09/2020", "manufacturer_contact_country": "", "date_changed": "20230908", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200807", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200930", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10381140", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200713", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "202085837", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: USED THE FIRST DATE OF THE MONTH OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED." }, { "mdr_text_key": "202085838", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VEIN GRAFT. FOLLOWING PRE-DILATATION OF A 2.5MM BALLOON CATHETER, A NON-BSC GUIDE EXTENSION CATHETER WAS INTRODUCED AND A 4 X 20 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED BUT IT FAILED TO DELIVER. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE STENT STRUTS WERE DAMAGED. PRE-DILATATION WAS PERFORMED AGAIN WITH A 3.0 BALLOON CATHETER AND ADVANCED A NEW SYNERGY DES AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED." }, { "mdr_text_key": "319655758", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D3 MODEL NUMBER UDPTED FROM UNKNOWN TO 10603. LOT NUMBER UPDATED FROM UNKNOWN TO 0024612501. CATALOG NUMBER UPDTED FROM UNKNOWN TO 10603. EXPIRATION DATE UPDATED FROM UNKNOWN TO 10/06/2021. UNIQUE IDENTIFIER (UDI) UPDATED FROM UNKNOWN TO #(B)(4). H4 DEVICE MANUFACTURE DATE UPDATED FROM UNKNOWN TO 10/07/2019. DEVICE EVALUATED BY MFR.: A SYNERGY II US MR 4.00 X 20MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS IN THE MID-SECTION OF THE STENT LIFTED AND DAMAGED. THE UNDAMAGED STENT OUTER DIAMETER WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. A 0.014\" GUIDEWIRE, VERIFIED WITH SNAP GAUGE, LOADED SUCCESSFULLY THROUGH THE DISTAL END OF THE TIP AND EXITED AT THE EXCHANGE PORT WITHOUT ISSUE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. B3 DATE OF EVENT: USED THE FIRST DATE OF THE MONTH OF THE AWARE DATE AS NO EVENT DATE WAS PROVIDED." }, { "mdr_text_key": "319655779", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VEIN GRAFT. FOLLOWING PRE-DILATATION OF A 2.5MM BALLOON CATHETER, A NON-BSC GUIDE EXTENSION CATHETER WAS INTRODUCED AND A 4 X 20 SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED BUT IT FAILED TO DELIVER. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE STENT STRUTS WERE DAMAGED. PRE-DILATATION WAS PERFORMED AGAIN WITH A 3.0 BALLOON CATHETER AND ADVANCED A NEW SYNERGY DES AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-10049", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200810", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200717", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200810", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20200102", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200810", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220101", "model_number": "10600", "catalog_number": "10600", "lot_number": "0024997784", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840008", "udi_public": "08714729840008", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Contamination with Chemical or Other Material" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200810", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200810", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10387960", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200720", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "202365544", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "202365545", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND ON THE DEVICE. A 3.50 X 8MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. THE DEVICE WAS OPENED IN A STERILE MANNER, HOWEVER, DURING PREPARATION, A FOREIGN OBJECT WAS OBSERVED. THE STENT WAS ADVANCED INTO THE GUIDE CATHETER BUT WOULD NOT PASS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-11127", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200814", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20200814", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190912", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200814", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210911", "model_number": "10605", "catalog_number": "10605", "lot_number": "0024465451", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200624", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840299", "udi_public": "08714729840299", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Failure to Advance" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200814", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200814", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10407375", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200723", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "202894711", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATION BY MFR.: SYNERGY II US MR 3.00 X 28 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION (VISUAL AND VIA SCOPE) OF THE CRIMPED STENT IDENTIFIED STENT DAMAGE. STENT STRUTS ON THE PROXIMAL AND MID STENT WAS BUNCHED DISTALLY. THE UNDAMAGED DISTAL CRIMPED STENT OUTER DIAMETER WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON WAS REVIEWED AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE HYPOTUBE KINKS. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT POLYMER EXTRUSION FOUND NO ISSUES. AN EXAMINATION (VISUAL AND VIA SCOPE) FOUND NO ISSUES WITH THE TIP. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "202894712", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23JUL2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 3.00 X 28 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03919", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20171212", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2024168" ], "fei_number": [ "2024168" ], "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000748", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189074934", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189074935", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH ANGINA. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X12MM BALLOON AT 10 ATMOSPHERES (ATMS), AND THE 3X18MM XIENCE STENT WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MYOCARDIAL INFARCTION (MI) 1472 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "318831784", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03920", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20170922", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2024168" ], "fei_number": [ "2024168" ], "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230718", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001405", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189079413", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189079414", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH UNSTABLE ANGINA. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X10MM BALLOON AT 13 ATMOSPHERES (ATMS), AND THE 3X15MM XIENCE STENT WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MYOCARDIAL INFARCTION (MI) 1391 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "319239790", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03923", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2024168" ], "fei_number": [ "2024168" ], "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001775", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189079709", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189079710", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IIT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X20MM BALLOON AT 6 ATMOSPHERES (ATMS), AND THE 3X38MM XIENCE STENT WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X15MM BALLOON AT 12 ATMS. THE PATIENT DEVELOPED THROMBOSIS AND A MI ON THE SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "318846019", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ATTACHMENT: [ARTICLE CN-030867.PDF]." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03924", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001863", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318760727", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "189078868", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189078869", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX CORONARY ARTERY. THE PATIENT PRESENTED WITH ANGINA. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X15MM BALLOON AT 10 ATMOSPHERES (ATMS), AND THE 3X18MM XIENCE STENT WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MYOCARDIAL INFARCTION (MI) 3 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03928", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131202", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE DRUG ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10002065", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318761511", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "189073638", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, AND OCCLUSION ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, OCCLUSION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189073639", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X15MM BALLOON AT 16 ATMOSPHERES (ATMS), AND THE 3.5X15MM XIENCE STENT WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MI 1 DAY LATER. ADDITIONALLY, THERE WAS REPORTED STENT JAILING (OCCLUSION) OF AN UNSPECIFIED VESSEL. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03932", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "2.75X28 XIENCE STENT" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003018", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318778974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [ARTICLE CN-030866.PDF]." }, { "mdr_text_key": "189232141", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189232142", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE MID TO DISTAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X20MM BALLOON AT 14 ATMOSPHERES (ATMS), AND THE 3.5X10MM XIENCE STENT WAS IMPLANTED AT 18 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X18MM BALLOON AT 14 ATMS. ANOTHER 2.75X28MM XIENCE STENT WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS PERFORMED AGAIN WITH AN UNSPECIFIED 2.5X15MM BALLOON AT 8 ATMS. THE PATIENT DEVELOPED THROMBOSIS AND A MI ON THE SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03943", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "XIENCE DRUG ELUTING CORONARY STENT", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230526", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005153", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189192042", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ADDITIONAL PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE MALFUNCTIONS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ABSORB REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIALNA - [(B)(4)]." }, { "mdr_text_key": "189192043", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALAPPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ALSO, IT WAS ALSO IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALAPPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"." }, { "mdr_text_key": "314986666", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03944", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "XIENCE DRUG ELUTING CORONARY STENT", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230815", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Myocardial Infarction", "Occlusion", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005231", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318795263", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4)." }, { "mdr_text_key": "189234459", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE ADDITIONAL PATIENT DEATH REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL DEVICE MALFUNCTIONS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL UNK ABSORB REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, CARDIAC ARREST, THROMBOSIS, AND OCCLUSION ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, CARDIAC ARREST, OCCLUSION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED." }, { "mdr_text_key": "189234460", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2024168-2020-03945", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "XIENCE DRUG ELUTING CORONARY STENT", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005254", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189234900", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE ADDITIONAL PATIENT DEATH REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL ABSORB REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189234901", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "318672411", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03949", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005730", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318794229", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ATTACHMENT: [E-24379 ARTICLE CN-030368.PDF]." }, { "mdr_text_key": "189243580", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE ADDITIONAL PATIENT DEATH REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL DEVICE MALFUNCTIONS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL UNK XIENCE REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, DISSECTION, AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF CORONARY SCAFFOLDS. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189243581", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS ALSO IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03950", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005781", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189206023", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THE ADDITIONAL PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE MALFUNCTIONS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE XIENCE REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF CORONARY SCAFFOLDS. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED." }, { "mdr_text_key": "189206024", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALAPPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALAPPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "311602206", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2024168-2020-03952", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005822", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189226673", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE PATIENT DEATHS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL XIENCE REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189226674", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "318670419", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03961", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20150204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230626", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10006104", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189214077", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF DEATH, MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIALNA." }, { "mdr_text_key": "189214078", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCATION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X20MM BALLOON AT 10 ATMOSPHERES (ATMS), AND THE 3.5X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X15MM BALLOON AT 12 ATMS. THE PATIENT DEVELOPED THROMBOSIS, MI, AND SUBSEQUENTLY DIED 430 DAYS LATER. TYPE OF TREATMENT, IF ANY, WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "315104135", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03964", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140311", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230526", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10006287", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189215831", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF DEATH, MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED." }, { "mdr_text_key": "189215832", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X15MM BALLOON AT 12 ATMOSPHERES (ATMS), AND THE 3.5X12MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X8MM BALLOON AT 22 ATMS. THE PATIENT DEVELOPED THROMBOSIS, MI, AND SUBSEQUENTLY DIED 100 DAYS LATER. TYPE OF TREATMENT, IF ANY, WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "314986630", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03983", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200429", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20150426", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200429", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200429", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/29/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200429", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10009235", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200429", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318668711", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "316327532", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT-DEVICE INCOMPATIBILITY WALL APPOSITION CANNOT BE DETERMINED. A CONCLUSIVE CAUSE FOR THE REPORTED THROMBOSIS AND MYOCARDIAL INFARCTION, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. H10: ADDITIONAL STATEMENT PROVIDED TO ADDRESS WALL APPOSITION." }, { "mdr_text_key": "190139503", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION IS LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED THROMBOSIS AND MYOCARDIAL INFARCTION, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "190139504", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X15MM BALLOON AT 10 ATMOSPHERES (ATMS), AND THE 3X12MM XIENCE STENT WAS IMPLANTED AT 16 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MI 511 DAYS LATER. ADDITIONALLY, MALPOSITION WAS OBSERVED. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/29/2020;07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03984", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200429", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20170406", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200429", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200429", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200429", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10009396", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318783125", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [ARTICLE CN-030878.PDF]." }, { "mdr_text_key": "190065331", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND CARDIAC ARREST ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "190065332", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X15MM BALLOON AT 6 ATMOSPHERES (ATMS), AND THE 3X18MM XIENCE STENT WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED WENT INTO CARDIAC ARREST 1222 DAYS LATER AND THROMBOSIS WAS IDENTIFIED. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_contact_pcity": "09170873", "event_type": "Injury", "report_number": "9612164-2020-01731", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200430", "manufacturer_address_2": "", "pma_pmn_number": "P110013", "date_of_event": "20190909", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "091708734", "noe_summarized": "1", "manufacturer_contact_l_name": "O'DOHERTY", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "BR", "manufacturer_contact_area_code": "091", "date_added": "20200430", "manufacturer_contact_f_name": "TONI", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200430", "brand_name": "RESOLUTE INTEGRITY RX", "generic_name": "STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/30/2020", "manufacturer_contact_country": "", "date_changed": "20200527", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "0917", "patient": [ { "patient_sequence_number": "1", "date_received": "20200430", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Injury" ] } ], "distributor_city": "", "date_report": "20200506", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "GALWAY", "mdr_report_key": "10013228", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200417", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC IRELAND", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196916767", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: DATE OF PUBLICATION. JOURNAL ARTICLE TITLE: CARDIOVASCULAR RISK STRATIFICATION FOR PATIENTS TREATED WITH DRUG-ELUTING STENTS: DEVELOPMENT AND VALIDATION OF THE DESIRE SCORE LITERATURE REFERENCE: PMID: 32123142. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "196916768", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS STUDY SOUGHT TO DEVELOP A RISK SCORE TO ESTIMATE THE RISK OF MAJOR ADVERSE CARDIAC EVENT (MACE) OCCURRENCE DURING THE IN-HOSPITAL AND LONG TERM FOLLOW-UP PERIODS AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH DRUG ELUTING STENTS (DES) IMPLANTATION. FROM MAY 2002 TO DECEMBER 2016, ALL CONSECUTIVE PATIENTS TREATED AT A SINGLE TERTIARY CENTER WITH ONE OR MORE DES WERE INCLUDED IN THE NON-RANDOMISED DRUG -ELUTING STENTS IN (B)(6) REGISTRY. COHORT A (2002-2006) REPRESENTS A HISTORICAL SAMPLE, SINCE IT INCLUDED THE INITIAL EXPERIENCE WITH THE FIRST GENERATION OF DES AND DUAL-ANTIPLATELET THERAPY (DAPT) FOR 3 MONTHS AFTER NON-MEDTRONIC SIROLIMUS-ELUTING STENT IMPLANTATION AND 6 MONTHS AFTER NON-MEDTRONIC PACLITAXEL-ELUTING STENT IMPLANTATION, ACCORDING TO THE RECOMMENDATIONS AT THE TIME. COHORT B (2007-2014) REFLECTS THE CONTEMPORARY INTERVENTIONAL CARDIOLOGY PRACTICE WITH THE INCORPORATION OF THE NEW-GENERATION METALLIC DES IMPLANTATION AND USE OF PROLONGED DA PT (FOR A MINIMUM OF 1 YEAR). HOWEVER, INCLUSION IN THE (B)(6) REGISTRY IS ONGOING. COHORT C REPRESENTS ALL PATIENTS ENROLLED AFTER DECEMBER 2014, INCLUDING INITIAL CASES WITH NON-MEDTRONIC BIORESORBABLE SCAFFOLDS AND NEW ANTIPLATELET DRUGS. THIS COHORT IS NOT THE FOCUS OF THE PRESENT ANALYSIS. TO DEVELOP THE DESIRE SCORE, COHORT B WAS SUBDIVIDED IN TWO GROUPS: COHORT B1 (2007-2012), WHICH AIMED TO DEVELOP THE SCORE WITH IN-HOSPITAL AND LATE MODELS; AND COHORT B2 (2013-2014), WHICH COMPRISES THE PATIENTS IN WHOM THE SCORE WAS PROSPECTIVELY VALIDATED, WITH A MINIMUM CLINICAL FOLLOW-UP OF 2 YEARS. RESOLUTE DRUG ELUTING STENTS WERE AMONGST THE STENTS USED IN THE COHORT B GROUPS. CLINICAL FOLLOW-UP, BY OFFICE APPOINTMENT OR PHONE CALL, WAS SCHEDULED AT 1 MONTH, 6 MONTHS, AND 12 MONTHS AFTER STENT IMPLANTATION, AND THEN ANNUALLY BASED ON INFORMATION ENTERED ON CASE REPORT FORMS AT THE TIME OF THE OFFICE VISIT/TELEPHONE CONTACT. BETWEEN JANUARY 2007 AND DECEMBER 2014, A TOTAL OF 4061 PATIENTS WERE ENROLLED IN THE (B)(6) REGISTRY AND COMPRISE THE B COHORT, WHICH IS ANALYZED IN THE PRESENT STUDY. VESSELS TREATED INCLUDE THE RCA, LCX, LAD, SVG AND LMS. THE PRIMARY OBJECTIVE OF THE PRESENT ANALYSIS WAS TO DEVELOP AN INDIVIDUAL RISK SCORE ABLE TO ESTIMATE THE ACUTE (IN-HOSPITAL) AND LATE RISK (UP TO 2 YEARS) OF COMBINED MACE, DEFINED AS CARDIAC DEATH, MYOCARDIAL INFARCTION (MI), AND ISCHEMIA-DRIVEN TARGET-LESION R EVASCULARIZATION (TLR). ADDITIONALLY, THESE SCORES WOULD BE VALIDATED FOR ACCURACY. THE SECONDARY OBJECTIVE WAS TO REPORT THE ACUTE AND LONG-TERM RATES OF THE INDIVIDUAL MACE COMPONENTS. COMPLETE FOLLOW-UP WAS ACHIEVED IN 96.5% OF THE CASES. MEDIAN FOLLOW-UP TIME WAS 4 YEARS IN THE B1 COHORT AND 2.1 YEARS IN THE B2 COHORT. CLINICAL OUTCOMES INCLUDED CARDIAC DEATH, MYOCARDIAL INFARCTION, REVASCULARIZATION AND STENT THROMBOSIS. IT WAS NOTED THAT THERE WERE ONLY 34 CASES OF STENT THROMBOSIS IN THE OVERALL POPULATION (0.84%), WITH NO DIFFERENCE BETWEEN THE GROUPS (0.84% IN COHORT B1 AND 0.83% IN COHORT B2; P=.90). USING DATA FROM THE (B)(6) REGISTRY, CONTEMPORARY MODELS WERE DEVELOPED AND VALIDATED FOR ASSESSING PERIPROCEDURAL AND LONG-TERM MACE RISK POST PCI, ENCOMPASSING THE FULL SPECTRUM OF PATIENT RISK AND SUBGROUPS, FOR BOTH IN-HOSPITAL AND LONG-TERM FOLLOW-UP PERIODS. THE STUDY CONCLUDED THAT THESE SCORES WILL BE VERY HELPFUL IN GUIDING THERAPEUTIC DECISIONS AND IN HELPING PATIENTS MAKE INFORMED DECISIONS." }, { "mdr_text_key": "201249648", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION: IT WAS STATED THAT THERE WERE NO CAUSAL RELATIONSHIP BETWEEN THE RESOLUTE DEVICES AND ANY OF THE CARDIAC DEATHS REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "PARKMORE BUSINESS PARK WEST", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "091", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "05/06/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04010", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200430", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20161201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200430", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200430", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230526", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200430", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10013459", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200409", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "314987063", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." }, { "mdr_text_key": "189454648", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ADDITIONAL PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. THE ABSORB DEVICE WAS NOT COMMERCIALLY AVAILABLE IN THE U.S. AT THE TIME OF IMPLANT; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. LITERATURE TITLE: ONE-YEAR CLINICAL PERFORMANCE OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN PATIENTS PRESENTING WITH ACUTE CORONARY SYNDROMES: RESULTS FROM THE RAI REGISTRY." }, { "mdr_text_key": "189454649", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB THAT MAY BE RELATED TO THE FOLLOWING: DEATH, TARGET LESION REVASCULARIZATION, MYOCARDIAL INFARCTION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED: ONE-YEAR CLINICAL PERFORMANCE OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN PATIENTS PRESENTING WITH ACUTE CORONARY SYNDROMES: RESULTS FROM THE RAI REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04011", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200430", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20161201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200430", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200430", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230811", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200430", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10013479", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200409", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318613592", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "190141257", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE PATIENT DEATHS WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. THE ABSORB DEVICE WAS NOT COMMERCIALLY AVAILABLE IN THE U.S. AT THE TIME OF IMPLANT; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. LITERATURE TITLE: ONE-YEAR CLINICAL PERFORMANCE OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN PATIENTS PRESENTING WITH ACUTE CORONARY SYNDROMES: RESULTS FROM THE RAI REGISTRY." }, { "mdr_text_key": "190141258", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB THAT MAY BE RELATED TO THE FOLLOWING: DEATH, TARGET LESION REVASCULARIZATION, MYOCARDIAL INFARCTION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: ONE-YEAR CLINICAL PERFORMANCE OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN PATIENTS PRESENTING WITH ACUTE CORONARY SYNDROMES: RESULTS FROM THE RAI REGISTRY" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04254", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200512", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20161128", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200512", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200512", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/15/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200512", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200731", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10049164", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200423", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190755469", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT AND IMPLANT: ESTIMATED DATE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE SCAFFOLD WAS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION." }, { "mdr_text_key": "190755470", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CASE REPORT WAS IDENTIFIED THROUGH AN ARTICLE, \u00bfA CASE REPORT OF A RECURRENT EARLY AND LATE BIORESORBABLE VASCULAR SCAFFOLD THROMBOSIS: SERIAL ANGIOGRAPHY AND OPTICAL COHERENCE TOMOGRAPHY FINDINGS\u00bf. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). PER IMAGING THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY HAD A TOTAL OCCLUSION. AFTER PRE-DILATATION, A 2.5X28MM ABSORB GT1 SCAFFOLD WAS IMPLANTED. ACUTE MALAPPOSITION, LIKELY DUE TO SCAFFOLD UNDER-SIZING, WAS OBSERVED AND POST-DILATATION WAS PERFORMED. AFTER, THE MALAPPOSITION WAS NO LONGER SIGNIFICANT. ASPIRIN AND CLOPIDOGREL WERE PRESCRIBED AND THE PATIENT WAS DISCHARGED. 16 DAYS LATER, THE PATIENT STOPPED TAKING ASPIRIN AND CLOPIDOGREL DUE TO A COLONOSCOPY. 20 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN. AN NSTEMI WAS DIAGNOSED AND MID SCAFFOLD THROMBOSIS OBSERVED. BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT. THE PATIENT WAS PRESCRIBED ASPIRIN AND TICAGRELOR AT DISCHARGE. 1 YEAR FOLLOW-UP, MILD STENOSIS MID-SCAFFOLD WAS OBSERVED, ALONG WITH PERI-STRUT LOW INTENSITY AREA (PLIA) AT THE PROXIMAL SCAFFOLD. THE MINIMAL LUMEN AREA (MLA) WAS 2.66MM2 AND NEOINTIMAL HYPERPLASIA WAS 55% WITHOUT SYMPTOMS ASSOCIATED. MEDICATION (ASPIRIN AND CLOPIDOGREL) WAS CONTINUED. 2-YEARS AFTER BVS IMPLANTATION, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN AT REST. A ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) WAS DIAGNOSED. PER IMAGING, LATE SCAFFOLD THROMBOSIS WITHIN THE PROXIMAL SCAFFOLD PORTION AND WITHIN AT THE SAME AREA AS THE PLIA, AND DISRUPTED SCAFFOLD STRUTS WERE ALSO OBSERVED. BALLOON ANGIOPLASTY WAS PERFORMED AND A 2.75X33MM XIENCE ALPINE STENT WAS IMPLANTED, COVERING THE ENTIRE SCAFFOLD SEGMENT. IMAGING SHOWED GOOD APPOSITION AS THE INTRA-LUMINAL DISMANTLED BVS STRUTS WERE COMPRESSED TOWARDS THE VESSEL WALL. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE." }, { "mdr_text_key": "318886258", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3, D6: ESTIMATED. D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THIS REPORT IS BEING RE-SUBMITTED TO PROVIDE THE ATTACHMENT BELOW AGAIN: ATTACHMENT: LITERATURE TITLED \"A CASE REPORT OF A RECURRENT EARLY AND LATE BIORESORBABLE VASCULAR SCAFFOLD THROMBOSIS: SERIAL ANGIOGRAPHY AND OPTICAL COHERENCE TOMOGRAPHY FINDINGS.\"NA - ATTACHMENT: [E-25913 ARTICLE NMS.PDF]." }, { "mdr_text_key": "316320892", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, RESTENOSIS AND ANGINA, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/29/2020;07/31/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04296", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200514", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200514", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200514", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230627", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10057569", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190983243", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH. EVENT, AND IMPLANT: ESTIMATED DATES. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF DEATH IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "190983244", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING; DEATH, MYOCARDIAL INFARCTION, SCAFFOLD THROMBOSIS, TARGET LESION REVASCULARIZATION, TARGET VESSEL REVASCULARIZATION AND RE-HOSPITALIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"TWO YEAR EFFICACY AND SAFETY OF SMALL VERSUS LARGE ABSORB BIORESORBABLE VASCULAR SCAFFOLDS OF =18 MM DEVICE LENGTH: A SUBGROUP ANALYSIS OF THE (B)(6) REGISTRY ((B)(6))\"." }, { "mdr_text_key": "315183528", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04298", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200514", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200514", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200514", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10057657", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318844736", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "191403366", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF EVENT AND IMPLANT: ESTIMATED DATES. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "191403367", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING; DEATH, MYOCARDIAL INFARCTION, SCAFFOLD THROMBOSIS, TARGET LESION REVASCULARIZATION, TARGET VESSEL REVASCULARIZATION AND RE-HOSPITALIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"TWO YEAR EFFICACY AND SAFETY OF SMALL VERSUS LARGE ABSORB BIORESORBABLE VASCULAR SCAFFOLDS OF =18 MM DEVICE LENGTH: A SUBGROUP ANALYSIS OF THE GERMAN-AUSTRIAN ABSORB REGISTRY (GABI-R)\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04334", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200514", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200514", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200514", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/13/2020", "manufacturer_contact_country": "", "date_changed": "20230814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Occlusion", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10059831", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200508", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318768546", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: MEAN AGE. B3, D6: ESTIMATED DATES. D4: THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF THROMBOSIS, RESTENOSIS AND OCCLUSION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE WAS NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT WAS SIMILAR TO A DEVICE SOLD IN THE U.S. LITERATURE ATTACHMENT: \u00bfPERI-STRUT LOW INTENSITY AREAS AND IN-SCAFFOLD NEOINTIMA GROWTH AFTER BIORESORBABLE SCAFFOLD IMPLANTATION IN STEMI. A SERIAL OPTICAL COHERENCE TOMOGRAPHY STUDY.\u00bf" }, { "mdr_text_key": "191076028", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WILL NOT RETURN FOR ANALYSIS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION. THE ABSORB DEVICE WAS NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT WAS SIMILAR TO A DEVICE SOLD IN THE U.S. LITERATURE: \u00bfPERI-STRUT LOW INTENSITY AREAS AND IN-SCAFFOLD NEOINTIMA GROWTH AFTER BIORESORBABLE SCAFFOLD IMPLANTATION IN STEMI. A SERIAL OPTICAL COHERENCE TOMOGRAPHY STUDY\u00bf (B)(4)." }, { "mdr_text_key": "191076029", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD MAY BE RELATED TO PERI-STRUT LOW INTENSITY AREAS (PSLA)S, IN SCAFFOLD NEOINTIMA GROWTH (NEOATHEROSCLEROSIS, NEOVASCULARIZATION, THIN-CAPPED FIBROATHEROMA, CALCIUM, PLAQUE/LIPIDS AND MACROPHAGES), THROMBOSIS, RESTENOSIS, TOTAL OCCLUSION, AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \u00bfPERI-STRUT LOW INTENSITY AREAS AND IN-SCAFFOLD NEOINTIMA GROWTH AFTER BIORESORBABLE SCAFFOLD IMPLANTATION IN STEMI. A SERIAL OPTICAL COHERENCE TOMOGRAPHY STUDY\u00bf." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04452", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200521", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200521", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200521", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200521", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10079172", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200506", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "311605301", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERAPY DATE ESTIMATED. THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "191707354", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF DEATH IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL PATIENT EFFECTS WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. \u00bfARTICLE TITLE-PROSPECTIVE, RANDOMIZED TRIAL OF BIORESORBABLE SCAFFOLDS VS. EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY STENTING FOR MYOCARDIAL INFARCTION: THE INTRACORONARY SCAFFOLD ASSESSMENT A RANDOMIZED EVALUATION OF ABSORB IN MYOCARDIAL INFARCTION (ISAR-ABSORB MI) TRIAL\u00bf. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. (B)(4)." }, { "mdr_text_key": "191707355", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK ABSORB THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, REVASCULARIZATION, THROMBOSIS, AND DEATH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: PROSPECTIVE, RANDOMIZED TRIAL OF BIORESORBABLE SCAFFOLDS VS. EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY STENTING FOR MYOCARDIAL INFARCTION: THE INTRACORONARY SCAFFOLD ASSESSMENT A RANDOMIZED EVALUATION OF ABSORB IN MYOCARDIAL INFARCTION (ISAR-ABSORB MI) TRIAL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04454", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200521", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200521", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200521", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230821", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200521", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10079197", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200506", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318854260", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "191732754", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE PATIENT DEATHS REFERENCED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. \u00bfARTICLE TITLE-PROSPECTIVE, RANDOMIZED TRIAL OF BIORESORBABLE SCAFFOLDS VS. EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY STENTING FOR MYOCARDIAL INFARCTION: THE INTRACORONARY SCAFFOLD ASSESSMENT A RANDOMIZED EVALUATION OF ABSORB IN MYOCARDIAL INFARCTION (ISAR-ABSORB MI) TRIAL\u00bf. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "191732755", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK ABSORB THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFRACTION, REVASCULARIZATION, THROMBOSIS, AND DEATH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: PROSPECTIVE, RANDOMIZED TRIAL OF BIORESORBABLE SCAFFOLDS VS. EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY STENTING FOR MYOCARDIAL INFARCTION: THE INTRACORONARY SCAFFOLD ASSESSMENT A RANDOMIZED EVALUATION OF ABSORB IN MYOCARDIAL INFARCTION (ISAR-ABSORB MI) TRIAL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04491", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200526", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200526", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200526", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "UNK", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230623", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200526", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10087792", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200505", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315219991", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4)." }, { "mdr_text_key": "192022980", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF DEATH/EVENT AND IMPLANT ARE ESTIMATED TO BE (B)(6) 2015. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF DEATH IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE." }, { "mdr_text_key": "192022981", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. 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THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE PATIENT DEATHS REFERENCED ARE BEING FILED ON A SEPARATE MEDWATCH REPORT #. LITERATURE. \u00bfARTICLE TITLE- PREDICTORS OF LONG-TERM ADVERSE EVENTS AFTER ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: A 1,933-PATIENT POOLED ANALYSIS FROM INTERNATIONAL REGISTRIES\"." }, { "mdr_text_key": "192156915", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. 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THE MAJORITY OF PATIENTS WERE MALE. THE DEVICE WAS IMPLANTED AND WILL NOT RETURN FOR ANALYSIS. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. LITERATURE ATTACHMENT: \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY.\" THE ADDITIONAL PATIENT EFFECTS AND THE XIENCE STENT REFERENCED, ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "193065402", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD AND XIENCE STENT MAY BE RELATED TO TARGET VESSEL MYOCARDIAL INFARCTION (MI), MI, DEVICE THROMBOSIS, CARDIAC DEATH, DEATH, ISCHEMIA-DRIVEN TARGET LESION REVASCULARIZATION, AND RESTENOSIS SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY.\u00bf" }, { "mdr_text_key": "316323309", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO 63 YEARS OF AGE A3: THE MAJORITY OF PATIENTS WERE MALE B3, D6: ESTIMATED D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF THROMBOSIS, MYOCARDIAL INFARCTION, ISCHEMIA AND RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD SYSTEM, ABSORB, INSTRUCTIONS FOR USE, AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/10/2020;07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04538", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200527", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20170718", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200527", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200527", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/03/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230526", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200527", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10094132", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "314986587", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "315216936", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO 63 YEARS OF AGE. A3: THE MAJORITY OF PATIENTS WERE MALE. B2, B3, D6: ESTIMATED. D4: THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.NA" }, { "mdr_text_key": "192353221", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE: THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO 63 YEARS OF AGE. SEX: THE MAJORITY OF PATIENTS WERE MALE. OUTCOMES TO ADVERSE EVENT, DATE OF EVENT, IMPLANT DATE: ESTIMATED. THE DEVICE WAS IMPLANTED AND WILL NOT RETURN FOR ANALYSIS. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. LITERATURE ATTACHMENT: \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY\". THE ADDITIONAL PATIENT EFFECTS AND THE ABSORB SCAFFOLD REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "192353222", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD AND XIENCE STENT MAY BE RELATED TO TARGET VESSEL MYOCARDIAL INFARCTION (MI), MI, DEVICE THROMBOSIS, CARDIAC DEATH, DEATH, ISCHEMIA-DRIVEN TARGET LESION REVASCULARIZATION, AND RESTENOSIS SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY\u00bf." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/10/2020;07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04539", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200527", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20170718", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200527", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200527", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/03/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200527", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10094152", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "192379973", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO 63 YEARS OF AGE. THE MAJORITY OF PATIENTS WERE MALE. THE DEVICE WAS IMPLANTED AND WILL NOT RETURN FOR ANALYSIS. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. LITERATURE : \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY\". THE ADDITIONAL PATIENT EFFECTS AND THE ABSORB SCAFFOLD REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "192379974", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD AND XIENCE STENT MAY BE RELATED TO TARGET VESSEL MYOCARDIAL INFARCTION (MI), MI, DEVICE THROMBOSIS, CARDIAC DEATH, DEATH, ISCHEMIA-DRIVEN TARGET LESION REVASCULARIZATION, AND RESTENOSIS SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ARTICLE TITLED: \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY\u00bf." }, { "mdr_text_key": "315996777", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO 63 YEARS OF AGE. A3: THE MAJORITY OF PATIENTS WERE MALE. B3, D6: ESTIMATED. D4: THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, ISCHEMIA, AND STENOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "318646278", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. NA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/10/2020;07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04582", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200528", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180824", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200528", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200528", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20130917", "model_number": "", "catalog_number": "1012464-18", "lot_number": "3032261", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/12/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200528", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "83", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stenosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10098722", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193305071", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT ESTIMATED. LITERATURE ATTACHMENT: CHRONIC TOTAL OCCLUSION 5 YEARS AFTER BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: A SERIAL OPTICAL COHERENCE TOMOGRAPHY ASSESSMENT. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "193305072", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A LITERATURE ARTICLE THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION WITH THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD. ON 8/24/2013 THE ABSORB SCAFFOLD WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. AT THE 12 AND 24 MONTH FOLLOW-UP VISITS, CORONARY ANGIOGRAM AND OPTICAL COHERENCE TOMOGRAPHY WERE PERFORMED. THESE TESTS SHOWED PRESERVED VESSEL PATENCY WITH SIGNS OF PERISTRUT LOW-INTENSITY AREAS WITHIN THE NEOINTIMA AND FEATURES OF ATHEROSCLEROSIS PROGRESSION AT THE DISTAL EDGE OF THE SCAFFOLD. THERE WERE NO SIGNS OF RESTENOSIS AT 12 AND 24 MONTHS. A SCHEDULED FOLLOW-UP ANGIOGRAPHY AT 60 MONTHS REVEALED A TOTAL OCCLUSION AT THE DISTAL PART OF THE SCAFFOLD. THE PATIENT DID NOT HAVE ANY SYMPTOMS. WITHIN THE PROXIMAL EDGE, OPTICAL COHERENCE TOMOGRAPHY SHOWED A COMPLETE ABSORPTION OF STENT STRUTS WITH NEOINTIMAL PROLIFERATION AND A DECREASED SCAFFOLD AREA AND DIAMETER WAS OBSERVED. ALTHOUGH THE EXACT REASON FOR THE OCCLUSION IS UNKNOWN, THE LOCATION OF THE OCCLUSION POINTS TO THE STENT EDGE RESTENOSIS AS THE REASON FOR OCCLUSION. THE OCCLUSION WAS TREATED WITH FOUR EVEROLIMUS ELUTING STENTS. THERE WAS GOOD STENT EXPANSION AND APPOSITION. NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "318842963", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318653162", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.B1: THERE WAS NO PRODUCT PROBLEM FOR THIS PATIENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/06/2020;07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04702", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200602", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20160508", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200602", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200602", "brand_name": "XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200602", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10113165", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200514", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193583540", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADVERSE EVENT, DATE OF EVENT, IMPLANT DATE: DATES ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. ARTICLE TITLED: ULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENTS VERSUS THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY REVASCULARISATION (BIOFLOW V): A RANDOMISED TRIALNA. (B)(4)." }, { "mdr_text_key": "193583541", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DETAILS ARE LISTED IN THE ARTICLE, TITLED \u00bfULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENTS VERSUS THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY REVASCULARISATION (BIOFLOW V): A RANDOMISED TRIAL.\" IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE STENTS THAT MAY BE RELATED TO THE FOLLOWING: DEATH, STENOSIS, MYOCARDIAL INFARCTION, LATE THROMBOSIS, AND REVASCULARIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "311604540", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04703", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200602", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20160508", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200602", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200602", "brand_name": "XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200602", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10113177", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200514", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318864508", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "193611394", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED PATIENT EFFECTS OF STENOSIS, THROMBOSIS, AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED STENOSIS, THROMBOSIS, AND MYOCARDIAL INFARCTION AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. ARTICLE ATTACHED TITLED: ULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENTS VERSUS THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY REVASCULARISATION (BIOFLOW V): A RANDOMISED TRIALNA." }, { "mdr_text_key": "193611395", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \u00bfULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENTS VERSUS THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY REVASCULARISATION (BIOFLOW V): A RANDOMISED TRIAL.\" IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE STENTS THAT MAY BE RELATED TO THE FOLLOWING: STENOSIS, MYOCARDIAL INFARCTION, LATE THROMBOSIS, DEATHS, AND REVASCULARIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04725", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200603", "manufacturer_address_2": "", "pma_pmn_number": "P110019", "date_of_event": "20061130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200603", "brand_name": "XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK RX PRIME", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/09/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10116739", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200511", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "311601042", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AGE OR DATE OF BIRTH: MEDIAN AGE SEX: MAJORITY OUTCOMES ATTRIBUTED TO ADVERSE EVENT, DATE OF EVENT: ESTIMATED. THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "193905719", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE OF EVENT: MEDIAN AGE. SEX: MAJORITY. ADVERSE EVENT: DATE OF EVENT: IF IMPLANTED DATE: ESTIMATED. THE DEVICE WAS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND XIENCE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHED: \u00bfEVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS." }, { "mdr_text_key": "193905720", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD AND THE XIENCE V, XIENCE PRIME, AND XIENCE XPEDITION STENTS MAY BE RELATED TO THROMBOSIS, TARGET LESION FAILURE (CARDIAC DEATH, TARGET VESSEL MYOCARDIAL INFARCTION, ISCHEMIA DRIVEN TARGET LESION REVASCULARIZATION), MYOCARDIAL INFARCTION, DEATH, AND IN DEVICE LATE LUMEN LOSS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \" EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS\u00bf." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04727", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200603", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20061130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200603", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE V", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/09/2020", "manufacturer_contact_country": "", "date_changed": "20230526", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10116813", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200511", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "314986614", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: MEDIAN AGE. 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THE DEVICE WAS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND XIENCE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHED: \u00bfEVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS.\u00bf (B)(4)." }, { "mdr_text_key": "193902281", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD AND THE XIENCE V, XIENCE PRIME, AND XIENCE XPEDITION STENTS MAY BE RELATED TO THROMBOSIS, TARGET LESION FAILURE (CARDIAC DEATH, TARGET VESSEL MYOCARDIAL INFARCTION, ISCHEMIA DRIVEN TARGET LESION REVASCULARIZATION), MYOCARDIAL INFARCTION, DEATH, AND IN DEVICE LATE LUMEN LOSS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. 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A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND XIENCE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHED: \u00bfEVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS.\u00bf (B)(4)." }, { "mdr_text_key": "193919978", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD AND THE XIENCE V, XIENCE PRIME, AND XIENCE XPEDITION STENTS MAY BE RELATED TO THROMBOSIS, TARGET LESION FAILURE (CARDIAC DEATH, TARGET VESSEL MYOCARDIAL INFARCTION, ISCHEMIA DRIVEN TARGET LESION REVASCULARIZATION), MYOCARDIAL INFARCTION, DEATH, AND IN DEVICE LATE LUMEN LOSS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. 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DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \" EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS.\u00bf" }, { "mdr_text_key": "318650678", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: MEDIAN AGE. A3: MAJORITY. B3, D6: ESTIMATED. D4: THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT(S) OF STENOSIS, ISCHEMIA, MYOCARDIAL INFARCTION, AND THROMBOSIS ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) OF STENOSIS, ISCHEMIA, MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04730", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200603", "manufacturer_address_2": "", "pma_pmn_number": "P110019", "date_of_event": "20061130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200603", "brand_name": "XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK RX XPEDITION", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/09/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10116852", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200511", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "311601210", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "193905139", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE OF EVENT: MEDIAN AGE. SEX: MAJORITY. ADVERSE EVENT; DATE OF EVENT; DEVICE IF IMPLANTED: ESTIMATED. THE DEVICE WAS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND XIENCE DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHED: \u00bfEVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS." }, { "mdr_text_key": "193905140", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD AND THE XIENCE V, XIENCE PRIME, AND XIENCE XPEDITION STENTS MAY BE RELATED TO THROMBOSIS, TARGET LESION FAILURE (CARDIAC DEATH, TARGET VESSEL MYOCARDIAL INFARCTION, ISCHEMIA DRIVEN TARGET LESION REVASCULARIZATION), MYOCARDIAL INFARCTION, DEATH, AND IN DEVICE LATE LUMEN LOSS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \" EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS\u00bf." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04731", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200603", "manufacturer_address_2": "", "pma_pmn_number": "P110019", "date_of_event": "20061130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200603", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200603", "brand_name": "XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK RX XPEDITION", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/09/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200603", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10116860", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200511", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318836792", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT(S) OF STENOSIS, THROMBOSIS, MYOCARDIAL INFARCTION, AND ISCHEMIA ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) OF STENOSIS, THROMBOSIS, MYOCARDIAL INFARCTION AND ISCHEMIA, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "193920888", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE: MEDIAN AGE. SEX: MAJORITY. THE DEVICE WAS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND XIENCE DEVICES ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE: \u00bfEVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS.\u00bf (B)(4)." }, { "mdr_text_key": "193920890", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD AND THE XIENCE V, XIENCE PRIME, AND XIENCE XPEDITION STENTS MAY BE RELATED TO THROMBOSIS, TARGET LESION FAILURE (CARDIAC DEATH, TARGET VESSEL MYOCARDIAL INFARCTION, ISCHEMIA DRIVEN TARGET LESION REVASCULARIZATION), MYOCARDIAL INFARCTION, DEATH, AND IN DEVICE LATE LUMEN LOSS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ARTICLE TITLED: \" EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS VERSUS EVEROLIMUS-ELUTING METALLIC STENTS: A META-ANALYSIS OF RANDOMISED CONTROLLED TRIALS\u00bf." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04919", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20161203", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "ABSORB BRS", " ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "68 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10143699", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318863850", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "194813797", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF THROMBOSIS IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. ARTICLE TITLED, VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "194813798", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT HAD TWO 2.5 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IMPLANTED IN THE RIGHT CORONARY ARTERY FOR A LENGTH OF 36 MM. ANGIOGRAPHIC FOLLOW UP CONFIRMED FAVORABLE RESULTS. 702 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH VERY LATE SCAFFOLD THROMBOSIS AND OCCLUSION IN THE DISTAL SCAFFOLD. THE AREA WAS TREATED WITH BALLOON DILATATION AND STENT IMPLANTATION. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04928", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160529", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230713", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "3.0X28 MM ABSORB", " 3.0X28 MM ABSORB" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10144852", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318964445", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "194864717", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "194864718", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND A 3.0X28 MM ABSORB BIORESORBABLE SCAFFOLD (BRS) WAS IMPLANTED IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. A STENOSIS OF THE MEDIAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WAS ALSO TREATED WITH A 3.0X28 MM ABOSORB BRS. SIX MONTH FOLLOW UP SHOWED A FAVORABLE RESULT IN BOTH AREAS. 514 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI AND THROMBOTIC OCCLUSION OF THE BRS IN THE LCX. FLOW WAS RESTORED AFTER BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT (DES). THE LAD LESION ALSO SHOWED DIFFUSE IN STENT RESTENOSIS WHICH WAS TREATED WITH A DES. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04929", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160529", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "3.0X28 MM ABSORB" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stenosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145096", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195369595", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT AND IMPLANT DATES ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF STENOSIS IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ATTACHMENT: ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195369596", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND A 3.0X28 MM ABSORB BIORESORBABLE SCAFFOLD (BRS) WAS IMPLANTED IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. A STENOSIS OF THE MEDIAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WAS ALSO TREATED WITH A 3.0X28 MM ABSORB BRS. SIX MONTH FOLLOW UP SHOWED A FAVORABLE RESULT IN BOTH AREAS. 514 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI AND THROMBOTIC OCCLUSION OF THE BRS IN THE LCX. FLOW WAS RESTORED AFTER BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT (DES). THE LAD LESION ALSO SHOWED DIFFUSE IN STENT RESTENOSIS WHICH WAS TREATED WITH A DES. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." }, { "mdr_text_key": "318665123", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04935", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20150101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2020", "manufacturer_contact_country": "", "date_changed": "20230717", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "2 ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145677", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319106260", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF DISSECTION, THROMBOSIS, STENOSIS, AND MYOCARDIAL INFARCTION ARE AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"NA" }, { "mdr_text_key": "195099257", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE 2 ADDITIONAL ABSORB DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHYNA." }, { "mdr_text_key": "195099258", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND SUBTOTAL OCCLUSION OF THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED WITH THREE ABSORB BIORESORBABLE SCAFFOLDS (BRS). TWO 3.5X28 MM AND ONE 3.5X15 MM WERE IMPLANTED. POST IMPLANT, A DISTAL EDGE DISSECTION WAS NOTED ON THE DISTAL BRS, AND A DRUG ELUTING STENT WAS IMPLANTED TO COVER THE DISSECTION. ANGIOGRAPHY POST IMPLANTATION SHOWED MILD RESTENOSIS IN THE MID RCA, WITH NO INDICATION FOR TREATMENT. 532 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED RECURRENT MYOCARDIAL INFARCTION WITH VERY LATE SCAFFOLD THROMBOSIS (VLSCT) AND SUBTOTAL THROMBOTIC OCCLUSION WITHIN THE SCAFFOLDED SEGMENT OF THE MID RCA. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SCAFFOLD DISCONTINUITY IN THE DISTAL BRS WITH OVERLYING THROMBUS. IN ADDITION, THERE WAS RESTENOSIS WITH AN OCT-DERIVED PERCENT LUMEN AREA STENOSIS OF 54%. THE LESION WAS TREATED WITH BALLOON DILATION FOLLOWED BY IMPLANTATION OF A DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/03/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04940", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "2 ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145807", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195369832", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE 2 ADDITIONAL ABSORB DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ATTACHMENT: ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195369833", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND SUBTOTAL OCCLUSION OF THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED WITH THREE ABSORB BIORESORBABLE SCAFFOLDS (BRS). TWO 3.5X28 MM AND ONE 3.5X15 MM WERE IMPLANTED. POST IMPLANT, A DISTAL EDGE DISSECTION WAS NOTED ON THE DISTAL BRS, AND A DRUG ELUTING STENT WAS IMPLANTED TO COVER THE DISSECTION. ANGIOGRAPHY POST IMPLANTATION SHOWED MILD RESTENOSIS IN THE MID RCA, WITH NO INDICATION FOR TREATMENT. 532 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED RECURRENT MYOCARDIAL INFARCTION WITH VERY LATE SCAFFOLD THROMBOSIS (VLSCT) AND SUBTOTAL THROMBOTIC OCCLUSION WITHIN THE SCAFFOLDED SEGMENT OF THE MID RCA. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SCAFFOLD DISCONTINUITY IN THE DISTAL BRS WITH OVERLYING THROMBUS. IN ADDITION, THERE WAS RESTENOSIS WITH AN OCT-DERIVED PERCENT LUMEN AREA STENOSIS OF 54%. THE LESION WAS TREATED WITH BALLOON DILATION FOLLOWED BY IMPLANTATION OF A DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" }, { "mdr_text_key": "315543965", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318652708", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS, STENOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/06/2020;08/03/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04942", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "2 ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145936", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195368222", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE 2 ADDITIONAL ABSORB DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ATTACHMENT: ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195368223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STEMI AND SUBTOTAL OCCLUSION OF THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED WITH THREE ABSORB BIORESORBABLE SCAFFOLDS (BRS). TWO 3.5X28 MM AND ONE 3.5X15 MM WERE IMPLANTED. POST IMPLANT, A DISTAL EDGE DISSECTION WAS NOTED ON THE DISTAL BRS, AND A DRUG ELUTING STENT WAS IMPLANTED TO COVER THE DISSECTION. ANGIOGRAPHY POST IMPLANTATION SHOWED MILD RESTENOSIS IN THE MID RCA, WITH NO INDICATION FOR TREATMENT. 532 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED RECURRENT MYOCARDIAL INFARCTION WITH VERY LATE SCAFFOLD THROMBOSIS (VLSCT) AND SUBTOTAL THROMBOTIC OCCLUSION WITHIN THE SCAFFOLDED SEGMENT OF THE MID RCA. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SCAFFOLD DISCONTINUITY IN THE DISTAL BRS WITH OVERLYING THROMBUS. IN ADDITION, THERE WAS RESTENOSIS WITH AN OCT-DERIVED PERCENT LUMEN AREA STENOSIS OF 54%. THE LESION WAS TREATED WITH BALLOON DILATION FOLLOWED BY IMPLANTATION OF A DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" }, { "mdr_text_key": "318840827", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318652949", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS, STENOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/06/2020;08/03/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04952", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20100101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230517", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146308", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200527", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315069003", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "194919997", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE: AVERAGE SEX: MAJORITY OUTCOMES TO ADVERSE EVENT, DATE OF EVENT, IMPLANT DATE: ESTIMATED. THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT. LITERATURE: BIORESORBABLE POLYMER-COATED THIN STRUT SIROLIMUS-ELUTING STENT VS DURABLE POLYMER-COATED EVEROLIMUS-ELUTING STENT IN DAILY CLINICAL PRACTICE: PROPENSITY MATCHED ONE-YEAR RESULTS FROM INTERVENTIONAL CARDIOLOGY NETWORK REGISTRY. (B)(4)." }, { "mdr_text_key": "194919998", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE XIENCE STENT MAY BE RELATED TO DEATH, ST ELEVATION, MYOCARDIAL INFARCTION, STENT THROMBOSIS (ACUTE, SUBACUTE, AND LATE), ISCHEMIA, REQUIRING HOSPITALIZATION, SURGICAL BYPASS, AND TARGET VESSEL REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \" BIORESORBABLE POLYMER-COATED THIN STRUT SIROLIMUS-ELUTING STENT VS DURABLE POLYMER-COATED EVEROLIMUS-ELUTING STENT IN DAILY CLINICAL PRACTICE: PROPENSITY MATCHED ONE-YEAR RESULTS FROM INTERVENTIONAL CARDIOLOGY NETWORK REGISTRY.\u00bf" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04953", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20100101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Non specific EKG/ECG Changes", "Ischemia", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146328", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200527", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318695750", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "194962142", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE OF PATIENT: AVERAGE. GENDER OF PATIENT: MAJORITY. THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, ISCHEMIA, AND THROMBOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE, AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE PATIENT DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. LITERATURE: BIORESORBABLE POLYMER-COATED THIN STRUT SIROLIMUS-ELUTING STENT VS DURABLE POLYMER-COATED EVEROLIMUS-ELUTING STENT IN DAILY CLINICAL PRACTICE: PROPENSITY MATCHED ONE-YEAR RESULTS FROM INTERVENTIONAL CARDIOLOGY NETWORK REGISTRY." }, { "mdr_text_key": "194962423", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE XIENCE STENT MAY BE RELATED TO DEATH, ST ELEVATION, MYOCARDIAL INFARCTION, STENT THROMBOSIS (ACUTE, SUBACUTE, AND LATE), ISCHEMIA, REQUIRING HOSPITALIZATION, SURGICAL BYPASS, AND TARGET VESSEL REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \" BIORESORBABLE POLYMER-COATED THIN STRUT SIROLIMUS-ELUTING STENT VS DURABLE POLYMER-COATED EVEROLIMUS-ELUTING STENT IN DAILY CLINICAL PRACTICE: PROPENSITY MATCHED ONE-YEAR RESULTS FROM INTERVENTIONAL CARDIOLOGY NETWORK REGISTRY.\u00bf" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04954", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "53 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200804", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146412", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195368476", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ATTACHMENT: ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195368477", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT HAD INTERVENTION OF THE RIGHT CORONARY ARTERY (RCA) WITH A 3.0X18 MM ABSORB BIORESORBABLE SCAFFOLD (BRS). FOLLOW UP 6 MONTHS LATER SHOWED A GOOD RESULT. 393 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND VERY LATE SCAFFOLD THROMBOSIS (VLSCT). INTRAPROCEDURAL OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SCAFFOLD DISCONTINUITY WITH MALPOSED STRUTS IN THE VESSEL LUMEN AND OVERLYING THROMBUS. FLOW WAS RESTORED WITH THROMBUS ASPIRATION AND BALLOON DILATATION. 46 DAYS LATER, THE PATIENT SUFFERED RECURRENT VLSCT. OCT WAS PERFORMED AND SHOWED MORE MARKED SCAFFOLD DISCONTINUITY WITH OVERLYING THROMBUS. THE PATIENT WAS TREATED WITH A DRUG ELUTING STENT (DES) WITH GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." }, { "mdr_text_key": "318840796", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHMENT ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/04/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04955", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170609", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2020", "manufacturer_contact_country": "", "date_changed": "20230817", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200804", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146495", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319014124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION, STENOSIS AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHMENT ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." }, { "mdr_text_key": "194963808", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHYNA." }, { "mdr_text_key": "194963809", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NSTEMI AND WAS TREATED WITH A 3.5X18 MM ABSORB BIORESORBABLE SCAFFOLD (BRS). 890 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED STEMI AND ANGIOGRAPHY SHOWED VERY LATE SCAFFOLD THROMBOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND SHOWED A FOCAL AREA OF MILD TO MODERATE RESTENOSIS, A TISSUE BRIDGE POSSIBLY CONSEQUENT ON MALPOSITION AND FOCAL SCAFFOLD DISCONTINUITY WITH THROMBOSIS. BALLOON DILATATION AND DRUG ELUTING STENT IMPLANTATION WAS PERFORMED WITH GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/04/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04957", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "71 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146595", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318766270", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." }, { "mdr_text_key": "318652874", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "194957544", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHYNA." }, { "mdr_text_key": "194957545", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT HAD A 3.5X12 MM ABSORB BIORESORBABLE SCAFFOLD IMPLANTED IN THE RIGHT CORONARY ARTERY. FOLLOW UP ANGIOGRAPHY SHOWED GOOD RESULT WITHOUT SIGNIFICANT RESTENOSIS. 478 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND VERY LATE THROMBOSIS IN THE PROXIMAL PORTION OF THE BRS. THE AREA WAS TREATED WITH THROMBUS ASPIRATION AND BALLOON DILATATION AND A DRUG ELUTING STENT WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/06/2020;07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04959", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20181211", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aneurysm", "Myocardial Infarction", "Tachycardia", "Thrombosis", "Ventricular Tachycardia" ] } ], "distributor_city": "", "date_report": "20200731", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146638", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195266103", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATE, DIAGNOSIS, IMPLANT: DATES ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195266104", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST- ELEVATED MYOCARDIAL INFARCTION (STEMI) AND HAD A 3.5X28 MM ABSORB BIORESORBABLE SCAFFOLD (BRS) IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. SIX MONTHS FOLLOW UP SHOWED A FAVORABLE RESULT. 1440 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH A NSTEMI AND RECURRENT NON-SUSTAINED VENTRICULAR TACHYCARDIA. ANGIOGRAPHY WITH OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED VERY LATE SCAFFOLD THROMBOSIS WITH THROMBOTIC MATERIAL AND FORMATION OF A LARGE ANEURYSM IN THE REGION OF THE IMPLANTED BRS. THE LESION WAS TREATED WITH A DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" }, { "mdr_text_key": "318840891", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318663216", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION, ANEURYSM, THROMBOSIS AND TACHYCARDIA, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.H6: PATIENT CODE 2132 REMOVED - ATTACHMENT: [ARTICLE SCAFFOLD THROMBOSIS.PDF]." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/07/2020;07/31/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04960", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170605", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "ABSORB BRS", " ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10148266", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318860628", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION, STENOSIS AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.B1 - ATTACHMENT: [CN-033801 ARTICLE.PDF]." }, { "mdr_text_key": "194966466", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE TITLED, VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "194966467", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND WAS TREATED WITH TWO 3.5X28 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IN THE RIGHT CORONARY ARTERY (RCA). FOLLOW UP ANGIOGRAPHY AT 15 MONTHS POST IMPLANT SHOWED A SATISFACTORY RESULT. 866 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI CAUSED BY VERY LATE SCAFFOLD THROMBOSIS. HEPARIN WAS GIVEN. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED THROMBOTIC MATERIAL SURROUNDING MALPOSED STRUTS IN THE LUMEN OF THE DISTAL RCA AT THE SITE OF SCAFFOLD DISCONTINUITY. THE AREA WAS TREATED WITH A DRUG ELUTING STENT WITH A GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04965", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190203", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "ABSORB BRS", " ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10148581", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318867540", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." }, { "mdr_text_key": "194971750", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "194971751", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A 3.0X18 MM AND A 3.5X12 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IN THE LEFT CIRCUMFLEX CORONARY ARTERY. SIX MONTH FOLLOW UP SHOWED A FAVORABLE RESULT. 1494 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND ANGIOGRAPHY SHOWED VERY LATE SCAFFOLD THROMBOSIS WITH THROMBOTIC OCCLUSION OF THE BRS. THE AREA WAS TREATED WITH BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT (SES). NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04966", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190203", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "ABSORB BRS", " ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10148611", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318766695", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [CN-033974.PDF]" }, { "mdr_text_key": "195022701", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195022702", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A 3.0X18 MM AND A 3.5X12 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IN THE LEFT CIRCUMFLEX CORONARY ARTERY. SIX MONTH FOLLOW UP SHOWED A FAVORABLE RESULT. 1494 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND ANGIOGRAPHY SHOWED VERY LATE SCAFFOLD THROMBOSIS WITH THROMBOTIC OCCLUSION OF THE BRS. THE AREA WAS TREATED WITH BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT (SES). NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04976", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170605", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230822", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "ABSORB BRS." ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10148904", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318871947", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318659413", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "195098065", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHYNA." }, { "mdr_text_key": "195098066", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND WAS TREATED WITH 2 3.5X28 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IN THE RIGHT CORONARY ARTERY (RCA). FOLLOW UP ANGIOGRAPHY AT 15 MONTHS POST IMPLANT SHOWED A SATISFACTORY RESULT. 866 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI CAUSED BY VERY LATE SCAFFOLD THROMBOSIS. HEPARIN WAS GIVEN. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED THROMBOTIC MATERIAL SURROUNDING MALAPPOSED STRUTS IN THE LUMEN OF THE DISTAL RCA AT THE SITE OF SCAFFOLD DISCONTINUITY. THE AREA WAS TREATED WITH A DRUG ELUTING STENT WITH A GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/01/2020;07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05136", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200618", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200618", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200618", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/18/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230818", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection", "Ischemia", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10167460", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200609", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318694914", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "195561388", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, ISCHEMIA AND DISSECTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE XIENCE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT#. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. LITERATURE TITLE: BIORESORBABLE VASCULAR SCAFFOLDS VERSUS DRUG-ELUTING STENTS FOR DIFFUSE LONG CORONARY NARROWINGS." }, { "mdr_text_key": "195561389", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK ABSORB THAT MAY BE RELATED TO THE FOLLOWING: DELIVERY FAILURE, DISSECTION, MYOCARDIAL INFARCTION, THROMBOSIS, ISCHEMIA, AND REVASCULARIZATION. ADDITIONALLY, THE ARTICLE IDENTIFIED UNK XIENCE THAT MAY BE RELATED TO THE FOLLOWING: DELIVERY FAILURE, DEATH, MYOCARDIAL INFRACTION, THROMBOSIS, ISCHEMIA, AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED: BIORESORBABLE VASCULAR SCAFFOLDS VERSUS DRUG-ELUTING STENTS FOR DIFFUSE LONG CORONARY NARROWINGS." }, { "mdr_text_key": "318664456", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NAH6: METHOD CODE 4111 REMOVED - [(B)(4)]." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/08/2020;07/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-05137", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20200618", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20180101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200618", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200618", "brand_name": "UNKNOWN XIENCEXIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10168023", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200609", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195571327", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, IMPLANT: DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ABSORB DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT#. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. ARTICLE TITLE: BIORESORBABLE VASCULAR SCAFFOLDS VERSUS DRUG-ELUTING STENTS FOR DIFFUSE LONG CORONARY NARROWINGS." }, { "mdr_text_key": "195571328", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK XIENCE THAT MAY BE RELATED TO THE FOLLOWING: DELIVERY FAILURE, DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, ISCHEMIA, AND REVASCULARIZATION. ADDITIONALLY, THE ARTICLE IDENTIFIED UNK ABSORB THAT MAY BE RELATED TO THE FOLLOWING: DELIVERY FAILURE, DISSECTION, MYOCARDIAL INFARCTION, THROMBOSIS, ISCHEMIA, AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED: BIORESORBABLE VASCULAR SCAFFOLDS VERSUS DRUG-ELUTING STENTS FOR DIFFUSE LONG CORONARY NARROWINGS." }, { "mdr_text_key": "311599897", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [CN-035257.PDF]" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05138", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20200618", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20180101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200618", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200618", "brand_name": "XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10168088", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200609", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195573311", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT, IMPLANT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF ISCHEMIA, THROMBOSIS, AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED ISCHEMIA, THROMBOSIS, AND MYOCARDIAL INFARCTION AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT#. THE ADDITIONAL ABSORB DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. ARTICLE TITLE: BIORESORBABLE VASCULAR SCAFFOLDS VERSUS DRUG-ELUTING STENTS FOR DIFFUSE LONG CORONARY NARROWINGS." }, { "mdr_text_key": "195573312", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK XIENCE THAT MAY BE RELATED TO THE FOLLOWING: DELIVERY FAILURE, DEATH, MYOCARDIAL INFRACTION, THROMBOSIS, ISCHEMIA, AND REVASCULARIZATION. ADDITIONALLY, THE ARTICLE IDENTIFIED UNK ABSORB THAT MAY BE RELATED TO THE FOLLOWING: DELIVERY FAILURE, DISSECTION, MYOCARDIAL INFARCTION, THROMBOSIS, ISCHEMIA, AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED: BIORESORBABLE VASCULAR SCAFFOLDS VERSUS DRUG-ELUTING STENTS FOR DIFFUSE LONG CORONARY NARROWINGS." }, { "mdr_text_key": "318666324", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-05199", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Off-Label Use" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/06/2020", "manufacturer_contact_country": "", "date_changed": "20230512", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "64 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis" ] } ], "distributor_city": "", "date_report": "20200723", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10178962", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315066405", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. IN THIS ARTICLE, THE BVS WAS USED IN THE LOWER EXTREMITIES. IT SHOULD BE NOTED THAT THE DEVICE IFU STATES: THE ABSORB BVS IS A TEMPORARY SCAFFOLD INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER THAT WILL EVENTUALLY RESORB AND POTENTIALLY FACILITATE NORMALIZATION OF VESSEL FUNCTION IN PATIENTS WITH ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI # IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. PATIENT CODE: SEPSIS ADDED. (B)(4)." }, { "mdr_text_key": "195929320", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF DEATH ESTIMATED AS (B)(6) 2018. DATE OF EVENT ESTIMATED AS (B)(6) 2018. DATE OF IMPLANT ESTIMATED AS (B)(6) 2017. (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL ADVERSE EVENTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. ARTICLE TITLE: EARLY AND MIDTERM EXPERIENCE WITH THE ABSORB EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD IN ASIAN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA: ONE-YEAR CLINICAL AND IMAGING OUTCOMES FROM THE DISAPPEAR REGISTRY." }, { "mdr_text_key": "195929321", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED EARLY AND MIDTERM EXPERIENCE WITH THE ABSORB EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD IN ASIAN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA: ONE-YEAR CLINICAL AND IMAGING OUTCOMES FROM THE DISAPPEAR REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/23/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05200", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Off-Label Use" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/06/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "64 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stenosis" ] } ], "distributor_city": "", "date_report": "20200723", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10178985", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318843641", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. IT SHOULD BE NOTED THAT THE IFU STATES: THE ABSORB BVS IS A TEMPORARY SCAFFOLD INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER THAT WILL EVENTUALLY RESORB AND POTENTIALLY FACILITATE NORMALIZATION OF VESSEL FUNCTION IN PATIENTS WITH ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED DIFFICULTY. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AND THE PART AND LOT # WERE NOT PROVIDED." }, { "mdr_text_key": "195925695", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT ESTIMATED AS (B)(6) 2018. DATE OF IMPLANT ESTIMATED AS (B)(6) 2017. (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE PATIENT DEATH(S) REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. LITERATURE ARTICLE TITLE: EARLY AND MIDTERM EXPERIENCE WITH THE ABSORB EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD IN ASIAN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA: ONE-YEAR CLINICAL AND IMAGING OUTCOMES FROM THE DISAPPEAR REGISTRY." }, { "mdr_text_key": "195925696", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED EARLY AND MIDTERM EXPERIENCE WITH THE ABSORB EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD IN ASIAN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA: ONE-YEAR CLINICAL AND IMAGING OUTCOMES FROM THE DISAPPEAR REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/23/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05209", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180706", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20180401", "model_number": "1235300-18", "catalog_number": "1235300-18", "lot_number": "6100461", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "08717648213045", "udi_public": "08717648213045", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/31/2020;11/02/2020;12/15/2020", "manufacturer_contact_country": "", "date_changed": "20230807", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "1 IMPLANTED ABSORB SCAFFOLD." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "77 YR", "patient_sex": "", "patient_weight": "62", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Stenosis" ] } ], "distributor_city": "", "date_report": "20201222", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10179822", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200529", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196074605", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "196074606", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2017, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE DISTAL RIGHT CORONARY ARTERY (RCA) LESION. FOLLOWING PRE-DILATATION, A 3.0X18MM ABSORB GT1 SCAFFOLD (1235300-18, 6100461) WAS SUCCESSFULLY IMPLANTED IN THE DISTAL RCA. ON (B)(6) 2017, ANOTHER PCI WAS PERFORMED. FOLLOWING PRE-DILATATION, A 3.0X23MM ABSORB SCAFFOLD (1235300-23, 6101161) WAS SUCCESSFULLY IMPLANTED IN THE 1ST DIAGONAL CORONARY ARTERY. THERE WERE NO ADVERSE EVENTS AND THERE WAS NO DEVICE MALFUNCTION. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED. A CORONARY ANGIOGRAM WAS PERFORMED AND SILENT MYOCARDIAL ISCHEMIA DIAGNOSED. THE DISTAL RCA, 3.0X18MM ABSORB SCAFFOLD, WAS OBSERVED WITH RESTENOSIS AND A FLARED STRUT. AS TREATMENT, AN ATHERECTOMY WAS PERFORMED. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO RESTENOSIS AND NO DEVICE ISSUE REGARDING THE 1ST DIAGONAL, 3.0X23MM ABSORB SCAFFOLD. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE." }, { "mdr_text_key": "320504764", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: THIS PATIENT EVENT WAS ALSO CAPTURED IN A PUBLISHED ARTICLE TITLED \" OVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION\u00bf IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE 3.0X18MM ABSORB GT1 SCAFFOLD WAS IMPLANTED WITHOUT A DEVICE ISSUE. PER OPTICAL COHERENCE TOMOGRAPHY, THE SCAFFOLD WAS COMPLETELY EMBEDDED IN THE VASCULAR ENDOTHELIUM. 12 MONTHS LATER AND PER IMAGING, THERE WAS NO RESTENOSIS, HOWEVER, THERE WAS DISCONTINUITY OF THE BVS AND SOME STRUTS APART FROM THE VESSEL. TORN STRUTS OVERHANGING INTO THE VASCULAR LUMEN, REMAINING STATIONARY ON THE ENDOTHELIUM AND RESISTANT TO CORONARY BLOOD FLOW WERE ALSO OBSERVED. DURING A FOLLOW-UP CATHERIIZATION, THE VESSEL WALL OF THE PROXIMAL SITE OF THE OVERHANGING BVS SHOWED POSITIVE REMODELING AND THERE WERE NO ATTACHED STRUTS. THE PHYSICIANS SPECULATE THAT PROMPT POSITIVE REMODELING CAUSED EARLY DISLODGEMENT AND SCHEDULED DEGENERATION OF THE DISLODGED STRUTS CAUSING THEM TO ROLL UP AND FALL ONTO THE DISTAL SIDE. DUAL ANTIPLATELET THERAPY WAS PROVIDED WITHOUT ANY ADVERSE EVENTS FOR 2 YEARS AFTER PCI.. DETAILS ARE FOUND IN THE ATTACHED ARTICLE: \u00bfOVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION\u00bf" }, { "mdr_text_key": "320504765", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE REMAINED IMPLANTED AND IS NOT RETURNING FOR ANALYSIS. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED REPORTING ADDITIONAL, RELEVANT INFORMATION. LITERATURE ATTACHED: \u00bfOVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION\u00bfB3: ESTIMATED DATE. THE ARTICLE REPORTS A NEW DATE OF OCCURRENCE AS ONE YEAR FOLLOWING THE INDEX PROCEDURE WHICH WAS PERFORMED ON (B)(6)2017. THE DATE OF OCCURRENCE HAS BEEN ESTIMATED AS (B)(6)2018." }, { "mdr_text_key": "320505031", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED:(B)(6)2018 DISCONTINUITY OF THE BVS AND SOME STRUTS APART FROM THE VESSEL WERE OBSERVED." }, { "mdr_text_key": "320505032", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.B3: ACTUAL DATE OF EVENT." }, { "mdr_text_key": "319286115", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND RESTENOSIS AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD SYSTEM, ABSORB, INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.B6:(B)(6)2019 : CORONARY ANGIOGRAM REMOVED AND REPLACED WITH THE CORRECT YEAR, (B)(6)2017 ." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/04/2020;11/19/2020;12/22/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05227", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140106", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Improper or Incorrect Procedure or Method", "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/24/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10181608", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318840498", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: MEAN AGE. A3: MAJORITY. B3, D6: ESTIMATED. D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS AND RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. IT SHOULD BE NOTED THAT THE IFU STATES: SIZE THE REFERENCE TARGET LESION DIAMETER APPROPRIATELY TO AVOID OVER EXPANDING THE SCAFFOLD TO ENSURE ADEQUATE SCAFFOLD APPOSITION. THIS WILL REDUCE THE RISK OF CAUSING SCAFFOLD DAMAGE. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT: \"EVEROLIMUS-ELUTING BIORESORBABLE STENT VS. DURABLE POLYMER EVEROLIMUS-ELUTING METALLIC STENT IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: RESULTS OF THE RANDOMIZED ABSORB ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION\u00bf TROFI II TRIAL\"." }, { "mdr_text_key": "196073978", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE: MEAN AGE, SEX: MAJORITY, DATE OF EVENT AND IMPLANT: ESTIMATED. THE DEVICE REMAINS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED WITH ADDITIONAL, RELEVANT INFORMATION. THE ABSORB DEVICE IS NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE XIENCE XPEDITION DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "196073979", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD AND THE XIENCE XPEDITION STENT MAY BE RELATED TO RESTENOSIS, MALAPPOSITION, AND TARGET LESION REVASCULARIZATION. ABSORB ONLY: A SUBACUTE THROMBOSIS WHICH LEAD TO A MYOCARDIAL INFARCTION (MI) AND REVASCULARIZATION. REPORTEDLY, THIS WAS DUE TO INADEQUATE MATCHING OF THE VESSEL SIZE AND DEVICE SELECTED (VESSEL SIZE WAS 1.92MM AND SCAFFOLD SELECTED WAS 2.5MM). SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \u00bfEVEROLIMUS-ELUTING BIORESORBABLE STENT VS. DURABLE POLYMER EVEROLIMUS-ELUTING METALLIC STENT IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: RESULTS OF THE RANDOMIZED ABSORB ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION\u00bf TROFI II TRIAL.\u00bf" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05230", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P110019", "date_of_event": "20140106", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK RX XPEDITION", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/08/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stenosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10181773", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318741970", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: MEAN AGE. A3: MAJORITY. B3, D6: ESTIMATED. D4: THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF STENOSIS, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE, IS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED WALL APPOSITION; HOWEVER, FACTORS THAT MAY CONTRIBUTE TO PATIENT-DEVICE INCOMPATIBILITY (WALL APPOSITION) INCLUDE, BUT ARE NOT LIMITED TO, INCORRECT DEVICE SIZE FOR LESION, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE AND INSUFFICIENT POST DILATION. THE REPORTED PATIENT EFFECT OF RESTENOSIS AND THERAPY APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT: \"ARTICLE TITLE - EVEROLIMUS-ELUTING BIORESORBABLE STENT VS. DURABLE POLYMER EVEROLIMUS-ELUTING METALLIC STENT IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: RESULTS OF THE RANDOMIZED ABSORB ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION\u00bf TROFI II TRIAL\"." }, { "mdr_text_key": "196066317", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE OF PATIENT: MEAN AGE. GENDER: MAJORITY. THE DEVICE REMAINS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED WITH ADDITIONAL, RELEVANT INFORMATION. THE ABSORB DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. LITERATURE: \"ARTICLE TITLE - EVEROLIMUS-ELUTING BIORESORBABLE STENT VS. DURABLE POLYMER EVEROLIMUS-ELUTING METALLIC STENT IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: RESULTS OF THE RANDOMIZED ABSORB ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION\u00bf TROFI II TRIAL.\"" }, { "mdr_text_key": "196066318", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD AND THE XIENCE XPEDITION STENT MAY BE RELATED TO RESTENOSIS, MALAPPOSITION, AND TARGET LESION REVASCULARIZATION. NOTE, ABSORB ONLY: A SUBACUTE THROMBOSIS WHICH LEAD TO A MYOCARDIAL INFARCTION (MI) AND REVASCULARIZATION. REPORTEDLY, THIS WAS DUE TO INADEQUATE MATCHING OF THE VESSEL SIZE AND DEVICE SELECTED (VESSEL SIZE WAS 1.92MM AND SCAFFOLD SELECTED WAS 2.5MM). SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ARTICLE TITLED: \u00bfEVEROLIMUS-ELUTING BIORESORBABLE STENT VS. DURABLE POLYMER EVEROLIMUS-ELUTING METALLIC STENT IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: RESULTS OF THE RANDOMIZED ABSORB ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION\u00bf TROFI II TRIAL.\u00bf" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05254", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200623", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20200201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200623", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200623", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "UNK", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Migration" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/08/2020", "manufacturer_contact_country": "", "date_changed": "20230718", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200623", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "77 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Vessel Or Plaque, Device Embedded In", "Angina", "Embolism", "Ischemia" ] } ], "distributor_city": "", "date_report": "20200813", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10185089", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196115333", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE REMAINED IMPLANTED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION. THE ABSORB DEVICE IS NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. LITERATURE, TITLED: MIGRATED REMNANT BIORESORBABLE SCAFFOLDS IN A LEFT MAIN BIFURCATION LESION: INSIGHTS FROM OPTICAL COHERENCE TOMOGRAPHY." }, { "mdr_text_key": "196115334", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN INDIVIDUAL CASE REPORT WAS OBTAINED FROM AN ARTICLE TITLED \u00bfMIGRATED REMNANT BIORESORBABLE SCAFFOLDS IN A LEFT MAIN BIFURCATION LESION: INSIGHTS FROM OPTICAL COHERENCE TOMOGRAPHY\u00bf. IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, A 3.5X28MM AND 3.0X28MM ABSORB SCAFFOLDS WERE IMPLANTED IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. A 3.0X18MM ABSORB SCAFFOLD WAS IMPLANTED IN THE DISTAL LEFT CIRCUMFLEX (CX) CORONARY ARTERY LESION. THREE YEARS LATER, THE PATIENT PRESENTED WITH EXERTIONAL CHEST PAIN. IMAGING WAS PERFORMED. THE LAD REMAINED PATENT, HOWEVER, SEVERE STENOSIS WAS OBSERVED IN THE PROXIMAL LCX WITH VERTICAL FILING DEFECT WITHIN THE LEFT MAIN (LM) CORONARY ARTERY. SCAFFOLD REMNANTS WERE OBSERVED IN THE LM BIFURCATED LESION. AS TREATMENT, TWO XIENCE SIERRA STENTS WERE SUCCESSFULLY IMPLANTED. FINAL ANGIOGRAPHY DISPLAYED GOOD DISTAL FLOW WITHOUT RESIDUAL STENOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE." }, { "mdr_text_key": "319227220", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3, D6: ESTIMATED DATE. D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF ANGINA, ISCHEMIA AND EMBOLISM, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHMENT: LITERATURE, TITLED: MIGRATED REMNANT BIORESORBABLE SCAFFOLDS IN A LEFT MAIN BIFURCATION LESION: INSIGHTS FROM OPTICAL COHERENCE TOMOGRAPHY.NA - ATTACHMENT: [E-29130 ARTICLE NMS.PDF]." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/13/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-05263", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200623", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200623", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200623", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230623", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200623", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10185918", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196144642", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, DIAGNOSIS, AND IMPLANT: DATES ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, IS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #." }, { "mdr_text_key": "196144783", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB BIORESORBABLE VASCULAR SCAFFOLDS (BVS) THAT MAY BE RELATED TO THE PATIENT EFFECTS OF DEATH, MYOCARDIAL INFARCTION (MI), TARGET LESION REVASCULARIZATION AND LATE SCAFFOLD THROMBOSIS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF EVEROLIMUS- AND BIOLIMUS-ELUTING CORONARY STENTS WITH EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS: TWO-YEAR CLINICAL OUTCOMES OF THE EVERBIO II TRIAL\" ." }, { "mdr_text_key": "315220012", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05265", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200623", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200623", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200623", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200623", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10185925", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318868055", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [CN-034160.PDF]." }, { "mdr_text_key": "196224913", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION, ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. ARTICLE TITLED \"COMPARISON OF EVEROLIMUS- AND BIOLIMUS-ELUTING CORONARY STENTS WITH EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS: TWO-YEAR CLINICAL OUTCOMES OF THE EVERBIO II TRIAL\"." }, { "mdr_text_key": "196224914", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB BIORESORBABLE VASCULAR SCAFFOLDS (BVS) THAT MAY BE RELATED TO THE PATIENT EFFECTS OF DEATH, MYOCARDIAL INFARCTION (MI), TARGET LESION REVASCULARIZATION AND LATE SCAFFOLD THROMBOSIS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF EVEROLIMUS- AND BIOLIMUS-ELUTING CORONARY STENTS WITH EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS: TWO-YEAR CLINICAL OUTCOMES OF THE EVERBIO II TRIAL\" ." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-05424", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200630", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20150607", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200630", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200630", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200630", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10212023", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200611", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "311603842", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "196948455", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENTS VERSUS THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY REVASCULARISATION (BIOFLOW V): A RANDOMISED TRIALNA." }, { "mdr_text_key": "196948456", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, THROMBOSIS, MYOCARDIAL INFARCTION, REVASCULARIZATION, REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 450 PATIENTS THAT WERE TREATED WITH XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENTS VERSUS THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY REVASCULARISATION (BIOFLOW V): A RANDOMISED TRIAL\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05426", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200630", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20150607", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200630", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200630", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200630", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10212044", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200611", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318890290", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ATTACHMENT: [E-29101 ARTICLE.PDF]." }, { "mdr_text_key": "196953490", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PATIENT DEATHS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED THROMBOSIS AND MYOCARDIAL INFARCTION AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENTS VERSUS THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY REVASCULARISATION (BIOFLOW V): A RANDOMISED TRIAL." }, { "mdr_text_key": "196953491", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, THROMBOSIS, MYOCARDIAL INFARCTION, REVASCULARIZATION, REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 450 PATIENTS THAT WERE TREATED WITH XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ULTRATHIN, BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENTS VERSUS THIN, DURABLE POLYMER EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY REVASCULARISATION (BIOFLOW V): A RANDOMISED TRIAL\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05978", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296006", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199499373", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199499374", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED 3X18MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS THAT SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05980", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE V", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296100", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199502666", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON. [(B)(4)]." }, { "mdr_text_key": "199502667", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN XIENCE V STENT THAT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED 3X18MM XIENCE V STENT WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS THAT SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05983", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121202", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296212", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199539101", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199539102", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED 3.5X18MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 1 DAY LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05991", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130307", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296272", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199550261", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199550262", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. AN UNSPECIFIED 3X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 96 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05996", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20130105", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE V", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296409", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199539978", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199539979", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE V STENT THAT WAS IMPLANTED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. AN UNSPECIFIED 3.5X23MM XIENCE V STENT WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 35 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06040", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200721", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200721", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200721", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200721", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10301430", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199690480", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: DATES ARE ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199690481", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. AN UNSPECIFIED 3.5X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS THAT SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06041", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200721", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121214", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200721", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200721", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200721", "sequence_number_treatment": [ "3.5X12MM ABSORB" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10301894", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199704936", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199704937", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. TWO UNSPECIFIED 3.5X12MM ABSORB BIODEGRADABLE SCAFFOLDS WERE IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 13 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-06124", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200722", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200722", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200725", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10311134", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199983700", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL XIENCE V AND RX MULTILINK DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "199983701", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE V, AND MULTILINK THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 870 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS, XIENCE V, AND MULTILINK STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06127", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200722", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200722", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10311258", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199985645", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PATIENT DEATHS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL XIENCE V AND RX MULTILINK DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED THROMBOSIS AND MYOCARDIAL INFARCTION AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "199985646", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE V, AND MULTILINK THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 870 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS, XIENCE V, AND MULTILINK STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-06132", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200722", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200722", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE V", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200725", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10311395", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199976925", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: DATES ESTIMATED. THE ADDITIONAL ADVERSE PATIENT EFFECTS WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL ABSORB AND RX MULTILINK DEVICES ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISONNA." }, { "mdr_text_key": "199976926", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE V, AND MULTILINK THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 870 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS, XIENCE V, AND MULTILINK STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06133", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200722", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200722", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE V", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10311419", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199989429", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED. THE PATIENT DEATHS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL ABSORB AND RX MULTILINK DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISONNA." }, { "mdr_text_key": "199989430", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE V, AND MULTILINK THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 870 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS, XIENCE V, AND MULTILINK STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-06180", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200724", "manufacturer_address_2": "", "pma_pmn_number": "P020047", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200724", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200724", "brand_name": "MULTI-LINK 8", "generic_name": "CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK RX MULTILINK", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/18/2020", "manufacturer_contact_country": "", "date_changed": "20230623", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200724", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200908", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10320488", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "200238521", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL XIENCE V AND ABSORB DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WILL NOT BE RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "200238522", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE V, AND MULTILINK THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THOMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 870 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS, XIENCE V, AND MULTILINK STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" }, { "mdr_text_key": "315221058", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B5: THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. B5: THE ADDITIONAL XIENCE V AND ABSORB DEVICES REFERENCED IN B5 ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE MULTI-LINK VISION RAPID EXCHANGE (RX) AND OVER THE WIRE (OTW) CORONARY STENT SYSTEMS (CSS), INTERNATIONAL, INSTRUCTIONS FOR USE IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/08/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-06184", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200724", "manufacturer_address_2": "", "pma_pmn_number": "P020047", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200724", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200724", "brand_name": "MULTI-LINK 8", "generic_name": "CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK RX MULTILINK", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/18/2020", "manufacturer_contact_country": "", "date_changed": "20230719", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200724", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200908", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10320668", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "200262530", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PATIENT DEATHS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL XIENCE V AND ABSORB DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WILL NOT BE RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "200262531", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE V, AND MULTILINK THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 870 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS, XIENCE V, AND MULTILINK STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" }, { "mdr_text_key": "319285751", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3, D6: DATES ESTIMATED. B5: THE PATIENT DEATHS REFERENCED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. B5: THE ADDITIONAL XIENCE V AND ABSORB DEVICES REFERENCED IN B5 ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS AS LISTED IN THE MULTI-LINK VISION RAPID EXCHANGE (RX) AND OVER THE WIRE (OTW) CORONARY STENT SYSTEMS (CSS), INTERNATIONAL, INSTRUCTIONS FOR USE ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED THROMBOSIS AND MYOCARDIAL INFARCTION AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/08/2020" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06408", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200803", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20200721", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "951", "date_added": "20200803", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200803", "brand_name": "ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20161107", "model_number": "", "catalog_number": "1234300-12", "lot_number": "5051361", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200803", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina", "Stenosis", "Test Result" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10355882", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200721", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201873242", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ABSORB GT1 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "201873243", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text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} ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06409", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200803", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20200721", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "951", "date_added": "20200803", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200803", "brand_name": "ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20160726", "model_number": "", "catalog_number": "1234350-18", "lot_number": "5072861", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200803", "sequence_number_treatment": [ "3X12MM ABSORB GT1" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina", "Stenosis", "Test Result" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10356069", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200721", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201369234", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ABSORB GT1 REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "201369235", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text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} ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "GA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "LOUISVILLE", "manufacturer_contact_address_1": "8195 INDUSTRIAL BLVD", "manufacturer_contact_pcity": "77078461", "event_type": "Malfunction", "report_number": "1018233-2020-05549", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200828", "manufacturer_address_2": "", "pma_pmn_number": "K161602", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "30014", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "7707846100", "noe_summarized": "1", "manufacturer_contact_l_name": "ANDERSON", "source_type": [ "HEALTH PROFESSIONAL", "OTHER", "USE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "80027", "manufacturer_g1_state": "CO", "reporter_country_code": "US", "manufacturer_contact_area_code": "770", "date_added": "20200828", "manufacturer_contact_f_name": "YONIC", "device_date_of_manufacturer": "20131201", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200828", "brand_name": "ARCTIC SUN 5000", "generic_name": "ARCTIC SUN DEVICE", "manufacturer_d_name": "MEDIVANCE, INC. \u00bf 1725056", "manufacturer_d_address_1": "321 S TAYLOR AVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "LOUISVILLE", "manufacturer_d_state": "CO", "manufacturer_d_zip_code": "80027", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "80027", "device_operator": "HEALTH PROFESSIONAL", "model_number": "50000000", "catalog_number": "50000000", "lot_number": "NA", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200609", "device_report_product_code": "DWJ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00801741080142", "udi_public": "(01)00801741080142", "openfda": { "device_name": "System, Thermal Regulating", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5900", "device_class": "2" } } ], "product_problems": [ "Defective Component" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210105", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7707", "patient": [ { "patient_sequence_number": "1", "date_received": "20200828", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200828", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "COVINGTON", "mdr_report_key": "10469067", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200806", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "80027", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDIVANCE, INC. \u00bf 1725056", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205359657", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS A FAULTY PROCESSOR CARD AND POWER CARD. THE DEVICE WAS EVALUATED UPON RECEIPT AND THE ALARM 61 WAS CONFIRMED AT STARTUP. THE PROCESSOR CARD AND POWER CARD WERE REPLACED. AFTER THE REPAIR, THE DEVICE UNDERWENT FUNCTIONAL EVALUATION. THE AS5000 WAS FUNCTIONALLY TESTED AND CALIBRATED ON THE AUTOMATED CALIBRATION AND TESTING SYSTEM. THE DEVICE PASSED ALL TESTING PER SERVICING PROCEDURES AND IS READY FOR USE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: \u00bfTHE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM IS INTENDED FOR MONITORING AND CONTROLLING PATIENT TEMPERATURE. WARNINGS AND CAUTIONS. WARNINGS: DO NOT USE THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM IN THE PRESENCE OF FLAMMABLE AGENTS BECAUSE AN EXPLOSION AND/OR FIRE MAY RESULT. DO NOT USE HIGH FREQUENCY SURGICAL INSTRUMENTS OR ENDOCARDIAL CATHETERS WHILE THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM IS IN USE. THERE IS A RISK OF ELECTRICAL SHOCK AND HAZARDOUS MOVING PARTS. THERE ARE NO USER SERVICEABLE PARTS INSIDE. DO NOT REMOVE COVERS. REFER SERVICING TO QUALIFIED PERSONNEL. POWER CORD HAS A HOSPITAL GRADE PLUG. GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED \u00bfHOSPITAL USE\u00bf OR \u00bfHOSPITAL GRADE\u00bf. WHEN USING THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM, NOTE THAT ALL OTHER THERMAL CONDUCTIVE SYSTEMS, SUCH AS WATER BLANKETS AND WATER GELS, IN USE WHILE WARMING OR COOLING WITH THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM MAY ACTUALLY ALTER OR INTERFERE WITH PATIENT TEMPERATURE CONTROL. DO NOT PLACE ARCTICGEL\u00bf PADS OVER TRANSDERMAL MEDICATION PATCHES AS WARMING CAN INCREASE DRUG DELIVERY, RESULTING IN POSSIBLE HARM TO THE PATIENT. CAUTIONS THIS PRODUCT IS TO BE USED BY OR UNDER THE SUPERVISION OF TRAINED, QUALIFIED MEDICAL PERSONNEL. FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, BY OR ON THE ORDER OF A PHYSICIAN. USE ONLY DISTILLED OR STERILE WATER. THE USE OF OTHER FLUIDS WILL DAMAGE THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM SYSTEM. WHEN MOVING THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM ALWAYS USE THE HANDLE TO LIFT THE CONTROLLER OVER AN OBSTACLE TO AVOID OVER BALANCING. THE PATIENT BED SURFACE SHOULD BE LOCATED BETWEEN 30 AND 60 INCHES (75 CM AND 150 CM) ABOVE THE FLOOR TO ENSURE PROPER FLOW AND MINIMIZE RISK OF LEAKS. THE CLINICIAN IS RESPONSIBLE TO DETERMINE THE APPROPRIATENESS OF CUSTOM PARAMETERS. WHEN THE SYSTEM IS POWERED OFF, ALL CHANGES TO PARAMETERS WILL REVERT TO THE DEFAULT UNLESS THE NEW SETTINGS HAVE BEEN SAVED AS NEW DEFAULTS IN THE ADVANCED SETUP SCREEN. FOR SMALL PATIENTS (=30 KG) IT IS RECOMMENDED TO USE THE FOLLOWING SETTINGS: WATER TEMPERATURE HIGH LIMIT =40\u00b0C (104\u00b0F); WATER TEMPERATURE LOW LIMIT =10\u00b0C (50 \u00b0F); CONTROL STRATEGY =2. THE OPERATOR MUST CONTINUOUSLY MONITOR PATIENT TEMPERATURE WHEN USING MANUAL CONTROL AND ADJUST THE TEMPERATURE OF THE WATER FLOWING THROUGH THE PADS ACCORDINGLY. PATIENT TEMPERATURE WILL NOT BE CONTROLLED BY THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM IN MANUAL CONTROL. DUE TO THE SYSTEMS HIGH EFFICIENCY, MANUAL CONTROL IS NOT RECOMMENDED FOR LONG DURATION USE. THE OPERATOR IS ADVISED TO USE THE AUTOMATIC THERAPY MODES (E.G. CONTROL PATIENT, COOL PATIENT, REWARM PATIENT) FOR AUTOMATIC PATIENT TEMPERATURE MONITORING AND CONTROL. THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM WILL MONITOR AND CONTROL PATIENT CORE TEMPERATURE BASED ON THE TEMPERATURE PROBE ATTACHED TO THE SYSTEM. THE CLINICIAN IS RESPONSIBLE FOR CORRECTLY PLACING THE TEMPERATURE PROBE AND VERIFYING THE ACCURACY AND PLACEMENT OF THE PATIENT PROBE AT THE START OF THE PROCEDURE. MEDIVANCE RECOMMENDS MEASURING PATIENT TEMPERATURE FROM A SECOND SITE TO VERIFY PATIENT TEMPERATURE. MEDIVANCE RECOMMENDS THE USE OF A SECOND PATIENT TEMPERATURE PROBE CONNECTED TO THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM TEMPERATURE 2 INPUT AS IT PROVIDES CONTINUOUS MONITORING AND SAFETY ALARM FEATURES. ALTERNATIVELY, PATIENT TEMPERATURE MAY BE VERIFIED PERIODICALLY WITH INDEPENDENT INSTRUMENTATION. THE DISPLAYED TEMPERATURE GRAPH IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO REPLACE STANDARD MEDICAL RECORD DOCUMENTATION FOR USE IN THERAPY DECISIONS. PATIENT TEMPERATURE WILL NOT BE CONTROLLED AND ALARMS ARE NOT ENABLED IN STOP MODE. PATIENT TEMPERATURE MAY INCREASE OR DECREASE WITH THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM IN STOP MODE. CAREFULLY OBSERVE THE SYSTEM FOR AIR LEAKS BEFORE AND DURING USE. IF THE PADS FAIL TO PRIME OR A SIGNIFICANT CONTINUOUS AIR LEAK IS OBSERVED IN THE PAD RETURN LINE, CHECK CONNECTIONS. IF NEEDED, REPLACE THE LEAKING PAD. LEAKAGE MAY RESULT IN LOWER FLOW RATES AND POTENTIALLY DECREASE THE PERFORMANCE OF THE SYSTEM. THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM IS FOR USE ONLY WITH THE ARCTICGEL\u00bf PADS. THE ARCTICGEL\u00bf PADS ARE ONLY FOR USE WITH THE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEMS. THE ARCTICGEL\u00bf PADS ARE NON-STERILE FOR SINGLE PATIENT USE. DO NOT REPROCESS OR STERILIZE. IF USED IN A STERILE ENVIRONMENT, PADS SHOULD BE PLACED ACCORDING TO THE PHYSICIAN REQUEST, EITHER PRIOR TO THE STERILE PREPARATION OR STERILE DRAPING. ARCTICGEL\u00bf PADS SHOULD NOT BE PLACED ON A STERILE FIELD. USE PADS IMMEDIATELY AFTER OPENING. DO NOT STORE PADS ONCE THE KIT HAS BEEN OPENED. DO NOT PLACE ARCTICGEL\u00bf PADS ON SKIN THAT HAS SIGNS OF ULCERATION, BURNS, HIVES, OR RASH. WHILE THERE ARE NO KNOWN ALLERGIES TO HYDROGEL MATERIALS, CAUTION SHOULD BE EXERCISED WITH ANY PATIENT WHO HAS A HISTORY OF SKIN ALLERGIES OR SENSITIVITIES. DO NOT ALLOW CIRCULATING WATER TO CONTAMINATE THE STERILE FIELD WHEN PATIENT LINES ARE DISCONNECTED. THE WATER CONTENT OF THE HYDROGEL AFFECTS THE PAD ADHESION TO THE SKIN AND CONDUCTIVITY, AND THEREFORE, THE EFFICIENCY OF CONTROLLING PATIENT TEMPERATURE. PERIODICALLY CHECK THAT PADS REMAIN MOIST AND ADHERENT. REPLACE PADS WHEN THE HYDROGEL NO LONGER UNIFORMLY ADHERES TO THE SKIN. REPLACING PADS AT LEAST EVERY 5 DAYS IS RECOMMENDED. DO NOT PUNCTURE THE ARCTICGEL\u00bf PADS WITH SHARP OBJECTS. PUNCTURES WILL RESULT IN AIR ENTERING THE FLUID PATHWAY AND MAY REDUCE PERFORMANCE. IF ACCESSIBLE, EXAMINE THE PATIENT SKIN UNDER THE ARCTICGEL\u00bf PADS OFTEN, ESPECIALLY THOSE AT HIGHER RISK OF SKIN INJURY. SKIN INJURY MAY OCCUR AS A CUMULATIVE RESULT OF PRESSURE, TIME AND TEMPERATURE. DO NOT PLACE BEAN BAG OR OTHER FIRM POSITIONING DEVICES UNDER THE ARCTICGEL\u00bf PADS. DO NOT PLACE POSITIONING DEVICES UNDER THE PAD MANIFOLDS OR PATIENT LINES. THE RATE OF TEMPERATURE CHANGE AND POTENTIALLY THE FINAL ACHIEVABLE PATIENT TEMPERATURE IS AFFECTED BY MANY FACTORS. TREATMENT APPLICATION, MONITORING AND RESULTS ARE THE RESPONSIBILITY OF THE ATTENDING PHYSICIAN. IF THE PATIENT DOES NOT REACH TARGET TEMPERATURE IN A REASONABLE TIME OR THE PATIENT IS NOT ABLE TO BE MAINTAINED AT THE TARGET TEMPERATURE, THE SKIN MAY BE EXPOSED TO LOW OR HIGH WATER TEMPERATURES FOR AN EXTENDED PERIOD OF TIME WHICH MAY INCREASE THE RISK FOR SKIN INJURY. ENSURE THAT PAD SIZING / COVERAGE AND CUSTOM PARAMETER SETTINGS ARE CORRECT FOR THE PATIENT AND TREATMENT GOALS, WATER FLOW IS GREATER THAN OR EQUAL TO 2.3 LITERS PER MINUTE AND THE PATIENT TEMPERATURE PROBE IS IN THE CORRECT PLACE. FOR PATIENT COOLING, ENSURE ENVIRONMENTAL FACTORS SUCH AS EXCESSIVELY HOT ROOMS, HEAT LAMPS, AND HEATED NEBULIZERS ARE ELIMINATED, AND PATIENT SHIVERING IS CONTROLLED. OTHERWISE, CONSIDER INCREASING MINIMUM WATER TEMPERATURE, MODIFYING TARGET TEMPERATURE TO AN ATTAINABLE SETTING OR DISCONTINUING TREATMENT. FOR PATIENT WARMING, CONSIDER DECREASING MAXIMUM WATER TEMPERATURE, MODIFYING TARGET TEMPERATURE TO AN ATTAINABLE SETTING OR DISCONTINUING TREATMENT. DUE TO UNDERLYING MEDICAL OR PHYSIOLOGICAL CONDITIONS, SOME PATIENTS ARE MORE SUSCEPTIBLE TO SKIN DAMAGE FROM PRESSURE AND HEAT OR COLD. PATIENTS AT RISK INCLUDE THOSE WITH POOR TISSUE PERFUSION OR POOR SKIN INTEGRITY DUE TO DIABETES, PERIPHERAL VASCULAR DISEASE, POOR NUTRITIONAL STATUS, STEROID USE OR HIGH DOSE VASOPRESSOR THERAPY. IF WARRANTED, USE PRESSURE RELIEVING OR PRESSURE REDUCING DEVICES UNDER THE PATIENT TO PROTECT FROM SKIN INJURY. DO NOT ALLOW URINE, ANTIBACTERIAL SOLUTIONS OR OTHER AGENTS TO POOL UNDERNEATH THE ARCTICGEL\u00bf PADS. URINE AND ANTIBACTERIAL AGENTS CAN ABSORB INTO THE PAD HYDROGEL AND CAUSE CHEMICAL INJURY AND LOSS OF PAD ADHESION. REPLACE PADS IMMEDIATELY IF THESE FLUIDS COME INTO CONTACT WITH THE HYDROGEL. DO NOT PLACE ARCTICGEL\u00bf PADS OVER AN ELECTROSURGICAL GROUNDING PAD. THE COMBINATION OF HEAT SOURCES MAY RESULT IN SKIN BURNS. IF NEEDED, PLACE DEFIBRILLATION PADS BETWEEN THE ARCTICGEL\u00bf PADS AND THE PATIENT\u00bfS SKIN. CAREFULLY REMOVE ARCTICGEL\u00bf PADS FROM THE PATIENT\u00bfS SKIN AT THE COMPLETION OF USE. DISCARD USED ARCTICGEL\u00bf PADS IN ACCORDANCE WITH HOSPITAL PROCEDURES FOR MEDICAL WASTE. THE USB DATA PORT IS TO BE USED ONLY WITH A STANDALONE USB FLASH DRIVE. DO NOT CONNECT TO ANOTHER MAINS POWERED DEVICE DURING PATIENT TREATMENT. USERS SHOULD NOT USE CLEANING OR DECONTAMINATION METHODS DIFFERENT FROM THOSE RECOMMENDED BY THE MANUFACTURER WITHOUT FIRST CHECKING WITH THE MANUFACTURER THAT THE PROPOSED METHODS WILL NOT DAMAGE THE EQUIPMENT. DO NOT USE BLEACH (SODIUM HYPOCHLORITE) AS IT MAY DAMAGE THE SYSTEM. MEDIVANCE WILL NOT BE RESPONSIBLE FOR PATIENT SAFETY OR EQUIPMENT PERFORMANCE IF THE PROCEDURES TO OPERATE, MAINTAIN, MODIFY OR SERVICE THE MEDIVANCE ARCTIC SUN\u00ae TEMPERATURE MANAGEMENT SYSTEM ARE OTHER THAN THOSE SPECIFIED BY MEDIVANCE. ANYONE PERFORMING THE PROCEDURES MUST BE APPROPRIATELY TRAINED AND QUALIFIED.\"" }, { "mdr_text_key": "205359658", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A RESEARCH ARTICLE THAT ABSORB AND XIENCE STENTS MAY BE RELATED TO DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS, AND REVASCULARIZATION. RESULTS WERE ASSESSED AT A 5 YEAR FOLLOW UP. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE IN THE ATTACHED ARTICLE NAMED \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "321 S TAYLOR AVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "30014", "manufacturer_contact_exchange": "770", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-07276", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20191217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200901", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE V", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200902", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200901", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10478569", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200811", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205359537", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE AND THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ARTICLE TITLE: \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS.EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY.\"" }, { "mdr_text_key": "205359538", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A RESEARCH ARTICLE THAT ABSORB AND XIENCE STENTS MAY BE RELATED TO DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS, AND REVASCULARIZATION. RESULTS WERE ASSESSED AT A 5 YEAR FOLLOW UP. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE IN THE ATTACHED ARTICLE NAMED \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-07278", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20191217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200901", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE V", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200901", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10478616", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200811", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205186289", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: DATES ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE TREATMENT(S) APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE AND THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. LITERATURE ATTACHMENT: VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVSEXAMINATION STUDY." }, { "mdr_text_key": "205186290", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A RESEARCH ARTICLE THAT ABSORB AND XIENCE STENTS MAY BE RELATED TO DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS, AND REVASCULARIZATION. RESULTS WERE ASSESSED AT A 5 YEAR FOLLOW UP. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE IN THE ATTACHED ARTICLE NAMED \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-07279", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20191217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200901", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201005", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200901", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10479485", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200811", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205190316", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S. THE XIENCE DEVICE AND THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS." }, { "mdr_text_key": "205190317", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A RESEARCH ARTICLE THAT ABSORB AND XIENCE STENTS MAY BE RELATED TO DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS, AND REVASCULARIZATION. RESULTS WERE ASSESSED AT A 5 YEAR FOLLOW UP. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE IN THE ATTACHED ARTICLE NAMED \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-07280", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20191217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200901", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201001", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200901", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10479528", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200811", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205281965", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S. THE XIENCE DEVICE AND THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. LITERATURE ATTACHMENT. ARTICLE TITLE \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"NA." }, { "mdr_text_key": "205281966", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A RESEARCH ARTICLE THAT ABSORB AND XIENCE STENTS MAY BE RELATED TO DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS, AND REVASCULARIZATION. RESULTS WERE ASSESSED AT A 5 YEAR FOLLOW UP. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE IN THE ATTACHED ARTICLE NAMED \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-07335", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200903", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20140423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200903", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200903", "brand_name": "XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK RX XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201005", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200903", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200903", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10488102", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200811", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205493099", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ESTIMATED DATE OF DEATH/EVENT. THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. ESTIMATED DATE OF IMPLANT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE EVENTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER." }, { "mdr_text_key": "205493100", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THAT XIENCE STENTS MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, STENT-THROMBOSIS, BLEEDING, DEATH, REHOSPITALIZATION AND REVASCULARIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 231 PATIENTS THAT WERE TREATED WITH XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF LONG-TERM CLINICAL OUTCOMES IN MULTIVESSEL CORONARY ARTERY DISEASE PATIENTS TREATED EITHER WITH BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENT OR PERMANENT POLYMER EVEROLIMUS-ELUTING STENT: 5-YEAR RESULTS OF THE CENTURY II RANDOMIZED CLINICAL TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-07337", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200903", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20140423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200903", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200903", "brand_name": "XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK RX XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200903", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200903", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10488166", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200811", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205499581", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ESTIMATED DATE OF EVENT. THE UDI # IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. ESTIMATED DATE OF IMPLANT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED THROMBOSIS, MYOCARDIAL INFARCTION AND HEMORRHAGE AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE PATIENT DEATHS ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. LITERATURE: COMPARISON OF LONG-TERM CLINICAL OUTCOMES IN MULTIVESSEL CORONARY ARTERY DISEASE PATIENTS TREATED EITHER WITH BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENT OR PERMANENT POLYMER EVEROLIMUS-ELUTING STENT: 5-YEAR RESULTS OF THE CENTURY II RANDOMIZED CLINICAL TRIAL. (B)(4)." }, { "mdr_text_key": "205499582", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THAT XIENCE STENTS MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, STENT-THROMBOSIS, BLEEDING, DEATH, REHOSPITALIZATION AND REVASCULARIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 231 PATIENTS THAT WERE TREATED WITH XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF LONG-TERM CLINICAL OUTCOMES IN MULTIVESSEL CORONARY ARTERY DISEASE PATIENTS TREATED EITHER WITH BIORESORBABLE POLYMER SIROLIMUS-ELUTING STENT OR PERMANENT POLYMER EVEROLIMUS-ELUTING STENT: 5-YEAR RESULTS OF THE CENTURY II RANDOMIZED CLINICAL TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-08110", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200929", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160829", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "NL", "manufacturer_contact_area_code": "951", "date_added": "20200929", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200929", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200929", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200929", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10603283", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200909", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "209122761", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WAS NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "209122762", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT ON (B)(6) 2016, AN ABSORB SCAFFOLD WAS IMPLANTED IN AN UNSPECIFIED ARTERY. TWO DAYS POST SCAFFOLD IMPLANTATION, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND IN-STENT THROMBOSIS WAS NOTED. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-08245", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201002", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "BE", "manufacturer_contact_area_code": "951", "date_added": "20201002", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201002", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201002", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201002", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10623825", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200915", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "209780370", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT: ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS, AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE \u00bfBIOSOLVE-IV-REGISTRY: SAFETY AND PERFORMANCE OF THE MAGMARIS SCAFFOLD: 12-MONTH OUTCOMES OF THE FIRST COHORT OF 1,075 PATIENTS\". THE PATIENT DEATHS MENTIONED ARE FILED UNDER ANOTHER MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "209780371", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS IS FILED FOR THE PATIENT EFFECTS. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO THE FOLLOWING: DEATH, THROMBOSIS, MYOCARDIAL INFARCTION, REVASCULARIZATION AND RE-HOSPITALIZATION. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED BIOSOLVE-IV-REGISTRY: SAFETY AND PERFORMANCE OF THE MAGMARIS SCAFFOLD: 12-MONTH OUTCOMES OF THE FIRST COHORT OF 1,075 PATIENTS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-08244", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201002", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "BE", "manufacturer_contact_area_code": "951", "date_added": "20201002", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201002", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201005", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201002", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20201002", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10623864", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200915", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "209743567", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF DEATH - ESTIMATED. DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT - ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE \u00bfBIOSOLVE-IV-REGISTRY: SAFETY AND PERFORMANCE OF THE MAGMARIS SCAFFOLD: 12-MONTH OUTCOMES OF THE FIRST COHORT OF 1,075 PATIENTS\". THE OTHER SERIOUS ADVERSE EFFECTS MENTIONED ARE FILED UNDER ANOTHER MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "209743568", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS IS FILED FOR THE PATIENT DEATHS: IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO THE FOLLOWING: DEATH, THROMBOSIS, MYOCARDIAL INFARCTION, REVASCULARIZATION AND RE-HOSPITALIZATION. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED BIOSOLVE-IV-REGISTRY: SAFETY AND PERFORMANCE OF THE MAGMARIS SCAFFOLD: 12-MONTH OUTCOMES OF THE FIRST COHORT OF 1,075 PATIENTS. PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-08455", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20201009", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20160401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "951", "date_added": "20201009", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201009", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201009", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia" ] } ], "distributor_city": "", "date_report": "20201009", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10658983", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200922", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "210715075", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ESTIMATED DATE OF EVENT. THE UDI IS UNKNOWN BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. ESTIMATED DATE OF IMPLANT THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED ISCHEMIA AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE REPORTED PATIENT EFFECT OF ISCHEMIA IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE: \"SCAFFOLD UNDEREXPANSION AND LATE LUMEN LOSS AFTER BIORESORBABLE SCAFFOLD IMPLANTATION: INSIGHTS FROM ABSORB JAPAN TRIAL.\" THE ABSORB SCAFFOLD REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "210715076", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH PRESENTATION IDENTIFYING ABSORB SCAFFOLDS AND XIENCE STENTS THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, THROMBOSIS, RESTENOSIS, ISCHEMIA, REVASCULARIZATION, REHOSPITALIZATION AND ISSUES WITH STRUT APPOSITION FOR ABSORB SCAFFOLDS. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 400 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS AND XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"SCAFFOLD UNDEREXPANSION AND LATE LUMEN LOSS AFTER BIORESORBABLE SCAFFOLD IMPLANTATION: INSIGHTS FROM ABSORB JAPAN TRIAL.\" +MEAN GENDER IS MALE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-08602", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201014", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20201014", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201014", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/10/2020", "manufacturer_contact_country": "", "date_changed": "20230809", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201014", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20201127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10680893", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200922", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320336011", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4: THE UNIQUE DEVICE IDENTIFIER (UDI) IS NOT AVAILABLE BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, RESTENOSIS AND ISCHEMIA, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, ELECTRONIC INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "211472821", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ESTIMATED DATE OF EVENT. ESTIMATED DATE OF IMPLANT. THE STENT REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE: \"SCAFFOLD UNDEREXPANSION AND LATE LUMEN LOSS AFTER BIORESORBABLE SCAFFOLD IMPLANTATION: INSIGHTS FROM ABSORB JAPAN TRIAL.\" THE XIENCE STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "211472822", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH PRESENTATION IDENTIFYING ABSORB SCAFFOLDS AND XIENCE STENTS THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, THROMBOSIS, RESTENOSIS, ISCHEMIA, REVASCULARIZATION, REHOSPITALIZATION AND ISSUES WITH STRUT APPOSITION FOR ABSORB SCAFFOLDS AND XIENCE STENTS. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 400 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS AND XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"SCAFFOLD UNDEREXPANSION AND LATE LUMEN LOSS AFTER BIORESORBABLE SCAFFOLD IMPLANTATION: INSIGHTS FROM ABSORB JAPAN TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/27/2020" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-08850", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201022", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20200928", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "951", "date_added": "20201022", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201022", "brand_name": "ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB GT1", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201022", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina", "Stenosis" ] } ], "distributor_city": "", "date_report": "20201022", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10722005", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200928", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "212699273", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF TREATMENT AND IMPLANT: ESTIMATED DATE. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED DEVICE COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE ABSORB GT1 INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE." }, { "mdr_text_key": "212699274", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE UNSPECIFIED ABSORB GT1 SCAFFOLD WAS IMPLANTED ABOUT 4 YEARS AGO AND RESTENOSIS WAS NOTED ON (B)(6) 2020. THE PATIENT HAD CHEST DISCOMFORT. THE AREA WAS RE-STENTED. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-09118", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201102", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "AS", "manufacturer_contact_area_code": "951", "date_added": "20201102", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201102", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201103", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201102", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "82 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20201102", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10773318", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201013", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214293289", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF DEATH: ESTIMATED. DATE OF EVENT: ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT: ESTIMATED. THERE WERE NO REPORTED DEVICE MALFUNCTIONS AND THE PRODUCTS WERE NOT RETURNED AS THE SCAFFOLDS REMAIN IN THE ANATOMIES. A REVIEW OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORIES COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED DEATHS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. ARTICLE TITLE: \"LONG-TERM RESULTS OF A PROSPECTIVE, SINGLE-ARM EVALUATION OF EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS IN INFRAPOPLITEAL ARTERIES.\" THE OTHER ADVERSE PATIENT EFFECTS REFERENCED ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "214293290", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING: DEATH, RESTENOSIS, SCAFFOLD THROMBOSIS, OCCLUSION, PSEUDOANEURYSM, TARGET LESION REVASCULARIZATION AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 48 PATIENTS, 55 LIMBS, TREATED WITH 71 ABSORB SCAFFOLDS. DETAILS ARE LISTED IN THE ARTICLE TITLED, \"LONG-TERM RESULTS OF A PROSPECTIVE, SINGLE-ARM EVALUATION OF EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS IN INFRAPOPLITEAL ARTERIES.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09119", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201102", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "AS", "manufacturer_contact_area_code": "951", "date_added": "20201102", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201102", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201102", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "82 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Occlusion", "Thrombosis", "Stenosis", "Pseudoaneurysm" ] } ], "distributor_city": "", "date_report": "20201102", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10773355", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201013", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214774766", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT - ESTIMATED. THERE WERE NO REPORTED DEVICE MALFUNCTIONS AND THE PRODUCTS WERE NOT RETURNED AS THE SCAFFOLDS REMAIN IN THE ANATOMIES. A REVIEW OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORIES COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF RESTENOSIS, THROMBOSIS, OCCLUSION AND PSEUDOANEURYSM, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. ARTICLE TITLE: \"LONG-TERM RESULTS OF A PROSPECTIVE, SINGLE-ARM EVALUATION OF EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS IN INFRAPOPLITEAL ARTERIES\". THE PATIENT EFFECT OF DEATH IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "214774767", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING: DEATH, RESTENOSIS, SCAFFOLD THROMBOSIS, OCCLUSION, PSEUDOANEURYSM, TARGET LESION REVASCULARIZATION AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 48 PATIENTS, 55 LIMBS, TREATED WITH 71 ABSORB SCAFFOLDS. DETAILS ARE LISTED IN THE ARTICLE TITLED, \"LONG-TERM RESULTS OF A PROSPECTIVE, SINGLE-ARM EVALUATION OF EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS IN INFRAPOPLITEAL ARTERIES.\" PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09186", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201103", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130805", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "NL", "manufacturer_contact_area_code": "951", "date_added": "20201103", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201103", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201103", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10779911", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214522489", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. SPECIFIC ABSORB DEVICE PART AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED. THE PATIENT DEATHS REFERENCED ARE BEING REPORTED ON A SEPARATE MEDWATCH REPORT #. LITERATURE: THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN REAL-WORLD PRACTICE: LONG-TERM FOLLOW-UP OF THE AMC SINGLE CENTRE REAL WORLD PCI REGISTRY. AS THIS IS A PUBLISHED ARTICLE AND IS ATTACHED TO THE REPORTS, PATIENT INFORMATION IS INCLUDED." }, { "mdr_text_key": "214522490", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD THAT MAY BE RELATED TO DEATH, THROMBUS, MYOCARDIAL INFARCTION AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED, THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN REAL-WORLD PRACTICE: LONG-TERM FOLLOW-UP OF THE AMC SINGLE CENTRE REAL WORLD PCI REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03949", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005730", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318794229", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ATTACHMENT: [E-24379 ARTICLE CN-030368.PDF]." }, { "mdr_text_key": "189243580", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE ADDITIONAL PATIENT DEATH REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL DEVICE MALFUNCTIONS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL UNK XIENCE REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, DISSECTION, AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF CORONARY SCAFFOLDS. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189243581", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS ALSO IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03950", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005781", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189206023", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THE ADDITIONAL PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE MALFUNCTIONS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE XIENCE REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF CORONARY SCAFFOLDS. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED." }, { "mdr_text_key": "189206024", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALAPPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALAPPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "311602206", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2024168-2020-03952", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005822", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189226673", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE PATIENT DEATHS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL XIENCE REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189226674", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, CARDIAC ARREST, REVASCULARIZATION, REHOSPITALIZATION, MALPOSITION, AND STENTS JAILING OR OCCLUDING VESSELS. ADDITIONALLY, IT WAS IDENTIFIED THAT ABSORB MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, DISSECTION, REVASCULARIZATION, REHOSPITALIZATION, AND MALPOSITION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE AND ABSORB STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "318670419", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03961", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20150204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230626", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10006104", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189214077", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF DEATH, MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIALNA." }, { "mdr_text_key": "189214078", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCATION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X20MM BALLOON AT 10 ATMOSPHERES (ATMS), AND THE 3.5X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X15MM BALLOON AT 12 ATMS. THE PATIENT DEVELOPED THROMBOSIS, MI, AND SUBSEQUENTLY DIED 430 DAYS LATER. TYPE OF TREATMENT, IF ANY, WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "315104135", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-03964", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140311", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230526", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10006287", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189215831", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF DEATH, MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED." }, { "mdr_text_key": "189215832", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X15MM BALLOON AT 12 ATMOSPHERES (ATMS), AND THE 3.5X12MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X8MM BALLOON AT 22 ATMS. THE PATIENT DEVELOPED THROMBOSIS, MI, AND SUBSEQUENTLY DIED 100 DAYS LATER. TYPE OF TREATMENT, IF ANY, WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "314986630", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04010", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200430", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20161201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200430", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200430", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230526", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200430", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10013459", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200409", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "314987063", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." }, { "mdr_text_key": "189454648", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ADDITIONAL PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. THE ABSORB DEVICE WAS NOT COMMERCIALLY AVAILABLE IN THE U.S. AT THE TIME OF IMPLANT; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. LITERATURE TITLE: ONE-YEAR CLINICAL PERFORMANCE OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN PATIENTS PRESENTING WITH ACUTE CORONARY SYNDROMES: RESULTS FROM THE RAI REGISTRY." }, { "mdr_text_key": "189454649", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB THAT MAY BE RELATED TO THE FOLLOWING: DEATH, TARGET LESION REVASCULARIZATION, MYOCARDIAL INFARCTION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED: ONE-YEAR CLINICAL PERFORMANCE OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN PATIENTS PRESENTING WITH ACUTE CORONARY SYNDROMES: RESULTS FROM THE RAI REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04011", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200430", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20161201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200430", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200430", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230811", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200430", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10013479", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200409", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318613592", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "190141257", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE PATIENT DEATHS WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. THE ABSORB DEVICE WAS NOT COMMERCIALLY AVAILABLE IN THE U.S. AT THE TIME OF IMPLANT; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. LITERATURE TITLE: ONE-YEAR CLINICAL PERFORMANCE OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN PATIENTS PRESENTING WITH ACUTE CORONARY SYNDROMES: RESULTS FROM THE RAI REGISTRY." }, { "mdr_text_key": "190141258", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB THAT MAY BE RELATED TO THE FOLLOWING: DEATH, TARGET LESION REVASCULARIZATION, MYOCARDIAL INFARCTION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: ONE-YEAR CLINICAL PERFORMANCE OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN PATIENTS PRESENTING WITH ACUTE CORONARY SYNDROMES: RESULTS FROM THE RAI REGISTRY" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2647580-2020-01459", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200501", "manufacturer_address_2": "", "pma_pmn_number": "K090470", "date_of_event": "20200115", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "L" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200501", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200501", "brand_name": "PROTACK", "generic_name": "LAPAROSCOPE, GENERAL & PLASTIC SURGERY", "manufacturer_d_name": "US SURGICAL PUERTO RICO", "manufacturer_d_address_1": "201 SABANETAS INDUSTRIAL PARK", "manufacturer_d_address_2": "", "manufacturer_d_city": "PONCE", "manufacturer_d_state": "PR", "manufacturer_d_zip_code": "00716", "manufacturer_d_zip_code_ext": "4401", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "007164401", "device_operator": "HEALTH PROFESSIONAL", "model_number": "174006", "catalog_number": "174006", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GCJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10884521070400", "udi_public": "10884521070400", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/27/2020", "manufacturer_contact_country": "", "date_changed": "20230725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200501", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Edema", "Thrombosis", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10017663", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200416", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319685866", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE PHOTOGRAPHS PROVIDED WERE FROM A LITERATURE STUDY. A COMPUTER TOMOGRAPHY ANGIOGRAM REVEALED A SURGICAL TACKER AT THE ANATOMIC LOCATION OF THE LEFT COMMON ILIAC VEIN. DISTAL TO THE TACKER, THE LEFT ILIAC VEIN WAS NARROW, AND THE PROXIMAL LEFT ILIAC VEIN WAS EXTENDED, WITHOUT EVIDENCE OF A LOCAL HEMATOMA. THE PATIENT WAS DIAGNOSED WITH LEFT COMMON ILIAC DVT (DEEP VEIN THROMBOSIS). IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A MEDICAL COMPLICATION AS A RESULT OF DEVICE USAGE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE ALSO THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: DO NOT USE THE INSTRUMENT ON TISSUE(S) WHICH CANNOT BE INSPECTED VISUALLY FOR HEMOSTASIS. A MINIMUM OF 4 MM TISSUE THICKNESS IS REQUIRED WHEN APPLYING THE HELICAL FASTENER OVER UNDERLYING BONE, VESSELS, OR VISCERA. THIS DEVICE SHOULD NOT BE USED IN TISSUES THAT HAVE A DIRECT ANATOMIC RELATIONSHIP TO MAJOR VASCULAR STRUCTURES. THIS WOULD INCLUDE THE DEPLOYMENT OF HELICAL FASTENERS IN THE DIAPHRAGM IN THE VICINITY OF THE PERICARDIUM, AORTA OR INFERIOR VENA CAVA DURING DIAPHRAGMATIC HERNIA REPAIR. DO NOT USE IN ISCHEMIC OR NECROTIC TISSUE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189769611", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "TITLE: LAPAROSCOPIC SACROCOLPOPEXY COMPLICATION: ILIO-FEMORAL DEEP VEIN THROMBOSIS SOURCE: CORRESPONDENCE / EUROPEAN JOURNAL OF OBSTETRICS <(>&<)> GYNECOLOGY AND REPRODUCTIVE BIOLOGY 247 (2020) 257\u00bf271 H6: PATIENT CODES-C64343 (SURGICAL INTERVENTION). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189769613", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ACCORDING TO THE LITERATURE SOURCE OF THE STUDY PERFORMED ON A PATIENT, POST OPERATIVE A LAPAROSCOPIC SACROCOLPOPEXY, THE MESH WAS SECURED TO THE ANTERIOR LONGITUDINAL LIGAMENT ON THE PROMONTORY USING 4 NON-ABSORBABLE TACKERS. AT THE END OF THE SURGERY, THE MESH WAS COVERED BY PERITONEUM USING THE COMPANY'S BARBED SUTURE. ON THE THIRD POSTOPERATIVE DAY, THE PATIENT COMPLAINED OF SWELLING OF THE LEFT LEG. PHYSICAL EXAMINATION REVEALED A MILD PITTING EDEMA ALONG THE ENTIRE LEG. A SONOGRAPHIC DOPPLER STUDY OF THE LEFT LEG DEMONSTRATED NO EVIDENCE OF DVT (DEEP VEIN THROMBOSIS) BUT RATHER A LOW FLOW VELOCITY IN THE COMMON-FEMORAL VEIN REGION. A COMPUTER TOMOGRAPHY ANGIOGRAM REVEALED A SURGICAL TACKER AT THE ANATOMIC LOCATION OF THE LEFT COMMON ILIAC VEIN. DISTAL TO THE TACKER, THE LEFT ILIAC VEIN WAS NARROW AND THE PROXIMAL LEFT ILIAC VEIN WAS EXTENDED, WITHOUT EVIDENCE OF A LOCAL HEMATOMA. THE PATIENT WAS DIAGNOSED WITH LEFT COMMON ILIAC DVT (DEEP VEIN THROMBOSIS) AND WAS TREATED WITH ENOXAPARIN. ON THE SEVENTH POSTOPERATIVE DAY, THE PATIENT UNDERWENT ENDOVASCULAR ASPIRATION AND REMOVAL OF THE THROMBUS. A STENT GRAFT WAS PLACED AT THE NARROW VEIN PORTION WITH GOOD MORPHOLOGICAL RECONSTRUCTION. THE SUBSEQUENT DAY, SIGNIFICANT CLINICAL IMPROVEMENT WAS NOTED, WITH COMPLETE RESOLUTION OF THE SWELLING. THE CASE DESCRIBES A RARE COMPLICATION OF SACROCOLPOPEXY. IF DVT (ILIO-FEMORAL DEEP VEIN THROMBOSIS MAY RESULT FROM LOCAL ANATOMICAL CHANGES CAUSED BY TACKER PLACEMENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/03/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "1810189-2020-00039", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200506", "manufacturer_address_2": "", "pma_pmn_number": "18-286", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "LITERATUR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200506", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200506", "brand_name": "GELFOAM", "generic_name": "SPONGE, STERILE; CLASS III", "manufacturer_d_name": "PFIZER, INC. (DEVICE)", "manufacturer_d_address_1": "7000 PORTAGE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "KALAMAZOO", "manufacturer_d_state": "MI", "manufacturer_d_zip_code": "49001", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "49001", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "LMF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "1810189" ], "fei_number": [ "1810189" ], "device_name": "Agent, Absorbable Hemostatic, Collagen Based", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4490", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "manufacturer_contact_country": "", "date_changed": "20230906", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200506", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss" ] } ], "distributor_city": "", "date_report": "20200429", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10031029", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "322702011", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "QA REVIEW & RATIONALE: CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, PRODUCT INFORMATION, JUSTIFICATION, AND THE SITE ASSIGNMENT GRID WERE REVIEWED, AND THEY ARE ACCURATE AND APPROPRIATE. THE FULL INVESTIGATION WAS NOT PERFORMED AS PROVIDING THE BATCH RECORD INFORMATION IS THE MANUFACTURING SITE'S REQUIREMENT; THEREFORE, A SUMMARY INVESTIGATION WAS PERFORMED. THE FIELD FOR DEVICE MALFUNCTION IN CITI IS REQUIRED TO CONDITIONALLY POPULATE THE SEVERITY RANKING. SUMMARY OF INVESTIGATION: A FULL INVESTIGATION WAS NOT PERFORMED AS PROVIDING THE BATCH RECORD INFORMATION IS THE MANUFACTURING SITE'S REQUIREMENT. THEREFORE, A SUMMARY INVESTIGATION WAS PERFORMED. BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE/ INTRAOPERATIVE BLEEDING/ HEMORRHAGE. REVIEW OF THE MANUFACTURING SITE INVESTIGATION CONCLUDES PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE (SITE). CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE/ INTRAOPERATIVE BLEEDING/ HEMORRHAGE. THE POTENTIAL ROOT CAUSE OF THIS ISSUE AFTER REVIEW OF THE MANUFACTURING SITE INVESTIGATION CONCLUDES (NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (NAME) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE). THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. REGULATORY REPORTABILITY WILL BE DETERMINED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE." }, { "mdr_text_key": "322702012", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "EVENT VERBATIM [PREFERRED TERM] THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION [OFF LABEL USE], ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION [PRODUCT USE IN UNAPPROVED INDICATION], , NARRATIVE: THIS IS LITERATURE SPONTANEOUS REPORT FROM THE JOURNAL VASC INTERV RADIOL, [2019, VOL 30, PAGES 1060 - 1061 ENTITLED \"COMPLETE EXTERNAL ILIAC VEIN TRANSECTION DURING HIP ARTHROPLASTY REQUIRING STENT GRAFT RECONSTRUCTION WITH LONG-TERM FOLLOW-UP\". A CONTACTABLE PHYSICIAN REPORTED FOR A 50-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF INFECTED LEFT TOTAL HIP ARTHROPLASTY UNDERWENT LEFT TOTAL HIP PROSTHESIS REIMPLANTATION. THE PATIENT DEVELOPED MASSIVE BLEEDING INTRAOPERATIVELY, AND AN EMERGENT ANGIOGRAM WAS REQUESTED. PELVIC ARTERIOGRAPHY DEMONSTRATED MULTIPLE AREAS OF ACTIVE HEMORRHAGE ARISING FROM BRANCHES OF THE LEFT GLUTEAL ARTERY AND PROFUNDA FEMORIS TREATED WITH ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION. DESPITE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE, REQUIRING A MASSIVE TRANSFUSION PROTOCOL. PELVIC VENOGRAPHY DEMONSTRATED COMPLETE TRANSECTION OF THE LEFT EXTERNAL ILIAC VEIN SECONDARY TO A SCREW FROM THE TOTAL HIP ARTHROPLASTY. TRANSECTION OF THE EXTERNAL ILIAC VEIN COULD NOT BE CROSSED IN AN ANTEGRADE OR RETROGRADE FASHION. A DECISION WAS MADE TO PERFORM A RENDEZVOUS TECHNIQUE WITHIN THE RETROPERITONEUM. A \"0.035-INCH GLIDEWIRE\" WAS ADVANCED FROM A RIGHT COMMON FEMORAL APPROACH AND SNARED IN THE LEFT PELVIC RETROPERITONEAL SPACE BY USING A 9 X 15-MM EN SNARE. THE TRANSECTION WAS SPANNED WITH OVERLAPPING 10 X 100 MM AND 13 X 50 MM VIABAHN STENT GRAFTS. VENOGRAPHY CONFIRMED SUCCESSFUL REPAIR OF THE LEFT EXTERNAL ILIAC VEIN TRANSECTION. POSTOPERATIVELY THE PATIENT WAS GIVEN ENOXAPARIN SUBCUTANEOUSLY AND CONVERTED TO A 6-MONTH COURSE OF WARFARIN PRIOR TO DISCHARGE. THE PATIENT REMAINS ASYMPTOMATIC WITHOUT LEG SWELLING, PAIN, OR HEAVINESS WITH PROLONGED STANDING. PELVIC ULTRASOUND 7 YEARS AFTER THE INITIAL PROCEDURE CONFIRMED STENT GRAFT PATENCY. FOLLOW-UP (B)(6) 2020: THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT GROUP. THIS REPORT INCLUDED INVESTIGATIONAL RESULTS. OFF LABEL USE ADDED AS ADDITIONAL EVENTS. SUMMARY OF INVESTIGATION: A FULL INVESTIGATION WAS NOT PERFORMED AS PROVIDING THE BATCH RECORD INFORMATION IS THE MANUFACTURING SITE'S REQUIREMENT. THEREFORE, A SUMMARY INVESTIGATION WAS PERFORMED. BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE/ INTRAOPERATIVE BLEEDING/ HEMORRHAGE. REVIEW OF THE MANUFACTURING SITE INVESTIGATION CONCLUDES PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE (SITE). REGULATORY MARKET ASSESSMENT: REGULATORY IMPACT WAS NO. ROOT CAUSE/ CAPA: PROCESS RELATED WAS NO. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE/ INTRAOPERATIVE BLEEDING/ HEMORRHAGE. THE POTENTIAL ROOT CAUSE OF THIS ISSUE AFTER REVIEW OF THE MANUFACTURING SITE INVESTIGATION CONCLUDES (NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (NAME) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE). THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. REGULATORY REPORTABILITY WILL BE DETERMINED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. SAMPLES AVAILABLE WAS UNKNOWN.SITE SAMPLE STATUS WAS NOT RECEIVED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED, PELVIC ARTERIOGRAPHY DEMONSTRATED MULTIPLE AREAS OF ACTIVE HEMORRHAGE ARISING FROM BRANCHES OF THE LEFT GLUTEAL ARTERY AND PROFUNDA FEMORIS TREATED WITH ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION. DESPITE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE, REQUIRING A MASSIVE TRANSFUSION PROTOCOL. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SERIOUS INJURY TO PATIENT AND RESULT IN DETERIORATION IN STATE OF HEALTH OF THE PATIENT, IF IT WERE TO RECUR." }, { "mdr_text_key": "320375965", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "QA REVIEW & RATIONALE: CLASSIFICATION, SUB-CLASSIFICATION, PRIORITY, PRODUCT INFORMATION, JUSTIFICATION, AND THE SITE ASSIGNMENT GRID WERE REVIEWED, AND THEY ARE ACCURATE AND APPROPRIATE. THE FULL INVESTIGATION WAS NOT PERFORMED AS PROVIDING THE BATCH RECORD INFORMATION IS THE MANUFACTURING SITE'S REQUIREMENT; THEREFORE, A SUMMARY INVESTIGATION WAS PERFORMED. THE FIELD FOR DEVICE MALFUNCTION IN CITI IS REQUIRED TO CONDITIONALLY POPULATE THE SEVERITY RANKING. SUMMARY OF INVESTIGATION: A FULL INVESTIGATION WAS NOT PERFORMED AS PROVIDING THE BATCH RECORD INFORMATION IS THE MANUFACTURING SITE'S REQUIREMENT. THEREFORE, A SUMMARY INVESTIGATION WAS PERFORMED. BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE/ INTRAOPERATIVE BLEEDING/ HEMORRHAGE. REVIEW OF THE MANUFACTURING SITE INVESTIGATION CONCLUDES PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE (SITE). CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE/ INTRAOPERATIVE BLEEDING/ HEMORRHAGE. THE POTENTIAL ROOT CAUSE OF THIS ISSUE AFTER REVIEW OF THE MANUFACTURING SITE INVESTIGATION CONCLUDES (NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (NAME) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE). THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. REGULATORY REPORTABILITY WILL BE DETERMINED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. FOLLOW-UP (01JUN2020): OTHER TREND ASSESSMENT & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL' AND 'DELIVERY SYSTEM'HAS BEEN REVIEWED. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (APRIL 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (3); HOWEVER, THIS WAS DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SERIOUS/UNKNOWN', AND THERE WAS ONE MONTH (APRIL 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (2); HOWEVER, THESE WERE ALSO DUE TO A REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. SUMMARY OF INVESTIGATION FROM KALAMAZOO (EP)DIVISION WAS: DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. APRR REVIEW:A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATING TO THE REPORTED COMPLAINT. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. INVESTIGATIONAL REPORT CONCLUSION FROM KALAMAZOO (EP) DIVISION WAS: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. THE DCHU WILL DETERMINE THE NEED FOR REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER KALAMAZOO IS NOT REQUIRED." }, { "mdr_text_key": "320375966", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION [OFF LABEL USE], ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION [PRODUCT USE IN UNAPPROVED INDICATION]. NARRATIVE: THIS IS LITERATURE SPONTANEOUS REPORT FROM THE JOURNAL VASC INTERV RADIOL, 2019, VOL 30, PAGES 1060 - 1061 ENTITLED \"COMPLETE EXTERNAL ILIAC VEIN TRANSECTION DURING HIP ARTHROPLASTY REQUIRING STENT GRAFT RECONSTRUCTION WITH LONG-TERM FOLLOW-UP\". A CONTACTABLE PHYSICIAN REPORTED FOR A 50-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF INFECTED LEFT TOTAL HIP ARTHROPLASTY UNDERWENT LEFT TOTAL HIP PROSTHESIS REIMPLANTATION. THE PATIENT DEVELOPED MASSIVE BLEEDING INTRAOPERATIVELY, AND AN EMERGENT ANGIOGRAM WAS REQUESTED. PELVIC ARTERIOGRAPHY DEMONSTRATED MULTIPLE AREAS OF ACTIVE HEMORRHAGE ARISING FROM BRANCHES OF THE LEFT GLUTEAL ARTERY AND PROFUNDA FEMORIS TREATED WITH ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION. DESPITE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE, REQUIRING A MASSIVE TRANSFUSION PROTOCOL. PELVIC VENOGRAPHY DEMONSTRATED COMPLETE TRANSECTION OF THE LEFT EXTERNAL ILIAC VEIN SECONDARY TO A SCREW FROM THE TOTAL HIP ARTHROPLASTY. TRANSECTION OF THE EXTERNAL ILIAC VEIN COULD NOT BE CROSSED IN AN ANTEGRADE OR RETROGRADE FASHION. A DECISION WAS MADE TO PERFORM A RENDEZVOUS TECHNIQUE WITHIN THE RETROPERITONEUM. A \"0.035-INCH GLIDEWIRE\" WAS ADVANCED FROM A RIGHT COMMON FEMORAL APPROACH AND SNARED IN THE LEFT PELVIC RETROPERITONEAL SPACE BY USING A 9 X 15-MM EN SNARE. THE TRANSECTION WAS SPANNED WITH OVERLAPPING 10 X 100 MM AND 13 X 50 MM VIABAHN STENT GRAFTS. VENOGRAPHY CONFIRMED SUCCESSFUL REPAIR OF THE LEFT EXTERNAL ILIAC VEIN TRANSECTION. POSTOPERATIVELY THE PATIENT WAS GIVEN ENOXAPARIN SUBCUTANEOUSLY AND CONVERTED TO A 6-MONTH COURSE OF WARFARIN PRIOR TO DISCHARGE. THE PATIENT REMAINS ASYMPTOMATIC WITHOUT LEG SWELLING, PAIN, OR HEAVINESS WITH PROLONGED STANDING. PELVIC ULTRASOUND 7 YEARS AFTER THE INITIAL PROCEDURE CONFIRMED STENT GRAFT PATENCY. FOLLOW-UP (10AUG2020): THIS IS A FOLLOW-UP SPONTANEOUS REPORT RECEIVED FROM A PRODUCT QUALITY COMPLAINT GROUP. THIS REPORT INCLUDED INVESTIGATIONAL RESULTS. OFF LABEL USE ADDED AS ADDITIONAL EVENTS. SUMMARY OF INVESTIGATION: A FULL INVESTIGATION WAS NOT PERFORMED AS PROVIDING THE BATCH RECORD INFORMATION IS THE MANUFACTURING SITE'S REQUIREMENT. THEREFORE, A SUMMARY INVESTIGATION WAS PERFORMED. BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE/ INTRAOPERATIVE BLEEDING/ HEMORRHAGE. REVIEW OF THE MANUFACTURING SITE INVESTIGATION CONCLUDES PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE (SITE). REGULATORY MARKET ASSESSMENT: REGULATORY IMPACT WAS NO. ROOT CAUSE/ CAPA: PROCESS RELATED WAS NO. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT EXPERIENCED DEVICE INEFFECTIVE/ INTRAOPERATIVE BLEEDING/ HEMORRHAGE. THE POTENTIAL ROOT CAUSE OF THIS ISSUE AFTER REVIEW OF THE MANUFACTURING SITE INVESTIGATION CONCLUDES (NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (NAME) PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER (SITE). THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. REGULATORY REPORTABILITY WILL BE DETERMINED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO (NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. SAMPLES AVAILABLE WAS UNKNOWN.SITE SAMPLE STATUS WAS NOT RECEIVED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (01JUN2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INVESTIGATION RESULTS. OTHER TREND ASSESSMENT & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL' AND 'DELIVERY SYSTEM' HAS BEEN REVIEWED. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (APRIL 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (3); HOWEVER, THIS WAS DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SERIOUS/UNKNOWN', AND THERE WAS ONE MONTH (APRIL 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (2); HOWEVER, THESE WERE ALSO DUE TO A REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. SUMMARY OF INVESTIGATION FROM KALAMAZOO (EP)DIVISION WAS: DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. APRR REVIEW:A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATING TO THE REPORTED COMPLAINT. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. INVESTIGATIONAL REPORT CONCLUSION FROM KALAMAZOO (EP) DIVISION WAS: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. THE DCHU WILL DETERMINE THE NEED FOR REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER KALAMAZOO IS NOT REQUIRED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO ADDITIONAL INFORMATION IS EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED, PELVIC ARTERIOGRAPHY DEMONSTRATED MULTIPLE AREAS OF ACTIVE HEMORRHAGE ARISING FROM BRANCHES OF THE LEFT GLUTEAL ARTERY AND PROFUNDA FEMORIS TREATED WITH ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION. DESPITE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE, REQUIRING A MASSIVE TRANSFUSION PROTOCOL. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SERIOUS INJURY TO PATIENT AND RESULT IN DETERIORATION IN STATE OF HEALTH OF THE PATIENT, IF IT WERE TO RECUR." }, { "mdr_text_key": "194938014", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "EVENT VERBATIM [PREFERRED TERM]. THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE [DEVICE INEFFECTIVE], NARRATIVE: THIS IS LITERATURE SPONTANEOUS REPORT FROM THE JOURNAL VASC INTERV RADIOL, [2019, VOL 30, PAGES 1060 - 1061 ENTITLED \"COMPLETE EXTERNAL ILIAC VEIN TRANSECTION DURING HIP ARTHROPLASTY REQUIRING STENT GRAFT RECONSTRUCTION WITH LONG-TERM FOLLOW-UP\". A CONTACTABLE PHYSICIAN REPORTED FOR A 50-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF INFECTED LEFT TOTAL HIP ARTHROPLASTY UNDERWENT LEFT TOTAL HIP PROSTHESIS REIMPLANTATION. THE PATIENT DEVELOPED MASSIVE BLEEDING INTRAOPERATIVELY, AND AN EMERGENT ANGIOGRAM WAS REQUESTED. PELVIC ARTERIOGRAPHY DEMONSTRATED MULTIPLE AREAS OF ACTIVE HEMORRHAGE ARISING FROM BRANCHES OF THE LEFT GLUTEAL ARTERY AND PROFUNDA FEMORIS TREATED WITH ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION. DESPITE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE, REQUIRING A MASSIVE TRANSFUSION PROTOCOL. PELVIC VENOGRAPHY DEMONSTRATED COMPLETE TRANSECTION OF THE LEFT EXTERNAL ILIAC VEIN SECONDARY TO A SCREW FROM THE TOTAL HIP ARTHROPLASTY. TRANSECTION OF THE EXTERNAL ILIAC VEIN COULD NOT BE CROSSED IN AN ANTEGRADE OR RETROGRADE FASHION. A DECISION WAS MADE TO PERFORM A RENDEZVOUS TECHNIQUE WITHIN THE RETROPERITONEUM. A \"0.035-INCH GLIDEWIRE\" WAS ADVANCED FROM A RIGHT COMMON FEMORAL APPROACH AND SNARED IN THE LEFT PELVIC RETROPERITONEAL SPACE BY USING A 9 X 15-MM EN SNARE. THE TRANSECTION WAS SPANNED WITH OVERLAPPING 10 X 100 MM AND 13 X 50 MM VIABAHN STENT GRAFTS. VENOGRAPHY CONFIRMED SUCCESSFUL REPAIR OF THE LEFT EXTERNAL ILIAC VEIN TRANSECTION. POSTOPERATIVELY THE PATIENT WAS GIVEN ENOXAPARIN SUBCUTANEOUSLY AND CONVERTED TO A 6-MONTH COURSE OF WARFARIN PRIOR TO DISCHARGE. THE PATIENT REMAINS ASYMPTOMATIC WITHOUT LEG SWELLING, PAIN, OR HEAVINESS WITH PROLONGED STANDING. PELVIC ULTRASOUND 7 YEARS AFTER THE INITIAL PROCEDURE CONFIRMED STENT GRAFT PATENCY., COMMENT: BASED ON THE INFORMATION PROVIDED, PELVIC ARTERIOGRAPHY DEMONSTRATED MULTIPLE AREAS OF ACTIVE HEMORRHAGE ARISING FROM BRANCHES OF THE LEFT GLUTEAL ARTERY AND PROFUNDA FEMORIS TREATED WITH ABSORBABLE GELATIN (GELFOAM) AND COIL EMBOLIZATION. DESPITE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE, REQUIRING A MASSIVE TRANSFUSION PROTOCOL. THIS IS A SINGLE POTENTIAL DEVICE MALFUNCTION WHICH HAS A THEORETICAL RISK TO CAUSE SERIOUS INJURY TO PATIENT AND RESULT IN DETERIORATION IN STATE OF HEALTH OF THE PATIENT, IF IT WERE TO RECUR." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/24/2020;09/11/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1810189-2020-00041", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200511", "manufacturer_address_2": "", "pma_pmn_number": "18-286", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "L" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200511", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200511", "brand_name": "GELFOAM", "generic_name": "SPONGE, STERILE; CLASS III", "manufacturer_d_name": "PFIZER, INC.", "manufacturer_d_address_1": "235 EAST 42 STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "NEW YORK", "manufacturer_d_state": "NY", "manufacturer_d_zip_code": "10017", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "10017", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "LMF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "1810189" ], "fei_number": [ "1810189" ], "device_name": "Agent, Absorbable Hemostatic, Collagen Based", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4490", "device_class": "3" } } ], "product_problems": [ "Clumping in Device or Device Ingredient", "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "manufacturer_contact_country": "", "date_changed": "20230629", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200511", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " O", " R" ], "patient_age": "47 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula" ] } ], "distributor_city": "", "date_report": "20200429", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10043160", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318102320", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS FOLLOW-UP IS FROM THE PRODUCT QUALITY COMPLAINTS GROUP FOR GELFOAM STERILE SPONGE SIZE 50 X 4. DESCRIPTION OF COMPLAINT: PRODUCT COMPLAINT EXCHANGE: [ELEVATED FEVER WITHOUT DEMONSTRABLE INFECTION, MOST PROBABLY BECAUSE A PIECE OF GELFOAM MIGHT FORM A NIDUS OF INFECTION AND POTENTIATE BACTERIAL GROWTH]. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION WITH SEVERITY OF HARM S4. THE ROOT CAUSE ANALYSIS INDICATED THAT THE PFIZER SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE SAMPLE AVAILABILITY STATUS WAS UNKNOWN. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. A MEDICAL DEVICE TREND ANALYSIS WAS COMPLETED AND WAS ACCEPTABLE. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, IT WAS REPORTED POSTOPERATIVE REBLEEDING AND BILE LEAKAGE. THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE." }, { "mdr_text_key": "318102321", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "EVENT VERBATIM [PREFERRED TERM] HEPATOCUTANEOUS BILIARY FISTULA ORIGINATING FROM THE RIGHT LIVER LOBE [BILIARY FISTULA], A PIECE OF GEL FORM WITH NO SIGNS OF ABSORPTION/THE PIECE OF GELFOAM WAS NOT ABSORBED IN THAT TIME PERIOD [DEVICE ISSUE], , NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL OF ENDOVASCULAR RESUSCITATION AND TRAUMA MANAGEMENT, 2019, VOL. 3, NO. 2; PP. 77-79, ENTITLED 'GOSSYPIBOMA: IS IT ALWAYS WHAT IT APPEARS TO BE? A RARE COMPLICATION IN EVERYDAY PRACTIC.' ONE OF THE MOST WELL-KNOWN LOCAL AGENTS IS ABSORBABLE GELATIN (GELFOAM), WHICH IS USED IN MULTIPLE FIELDS OF SURGERY. HERE THE AUTHORS WE PRESENT A CASE OF A VERY RARE COMPLICATION WHILE USING GELFOAM, MIMICKING GOSSYPIBOMA. A 47-YEAR-OLD MALE PATIENT WAS ADMITTED TO THE TRAUMA UNIT AFTER BEING STABBED IN THE LOWER SEGMENT OF HIS RIGHT CHEST. HE ALSO HAD ADDITIONAL MULTIPLE STAB WOUNDS TO THE BACK, AND UPPER AND LOWER EXTREMITIES. ON ADMISSION, THE PATIENT LOOKED PALE AND AGITATED, HIS INITIAL BLOOD PRESSURE WAS 80/40, PULSE OVER 130 PER MINUTE. ON AUSCULTATION, BREATH SOUNDS WERE SLIGHTLY DIMINISHED ON THE RIGHT, WHERE A WOUND WITH EVISCERATION OF OMENTUM WAS SEEN 3 CM ABOVE THE RIGHT CHEST CAGE. AFTER INSERTION OF A CHEST TUBE INTO THE RIGHT THORAX, AND EVACUATION OF A SMALL AMOUNT OF AIR AND BLOOD, THE PATIENT WAS THEN IMMEDIATELY TAKEN TO THE OPERATING ROOM. DURING SURGERY, 1.5 L OF BLOOD WERE FOUND INSIDE THE ABDOMINAL CAVITY, A DEEP LIVER, SEGMENT IV, LACERATION WAS DEMONSTRATED, WITH ACTIVE ARTERIAL BLEEDING. IN ADDITION, A 3 CM DIAPHRAGMATIC TEAR WAS ALSO DEMONSTRATED. THE BLEEDING FROM THE LIVER WAS STOPPED BY THE INSERTION OF A PIECE OF GELFOAM INTO THE WOUND AND BY SUTURING OF THE LIVER ABOVE IN ORDER TO CREATE A LOCAL TAMPONADE EFFECT. THE PROCEDURE WAS COMPLETED WITH FORMAL LIVER PACKING, DIAPHRAGM REPAIR, AND THE ABDOMEN WAS CLOSED WITH A BOGOTA BAG, AS IS ACCEPTABLE IN \"DAMAGE CONTROL\". IN THE POST-SURGERY PERIOD, THE PATIENT WAS STABLE AND WAS THEN TRANSFERRED TO THE ANGIOGRAPHIC UNIT. ON ANGIOGRAPHY, EXTRAVASATION WAS DEMONSTRATED FROM ONE OF THE INTRAHEPATIC ARTERIES, AND SUCCESSFUL ANGIOEMBOLIZATION WAS ACHIEVED. FORTY-EIGHT HOURS LATER, A RELAPAROTOMY WAS PERFORMED AND THE LIVER PACKING WAS REMOVED. NO BLEEDING OR BILE LEAKAGE WERE OBSERVED, DRAINS WERE LEFT INSIDE THE ABDOMEN, AND THE ABDOMEN WAS SUTURED CLOSED. IN ADDITION, ALL SURGICAL INSTRUMENTS AND TAGGED PADS WERE ACCOUNTED FOR. AT POST-OPERATIVE DAY 6, AFTER THE SECOND OPERATION, BILE LEAKAGE WAS VISUALIZED IN A DRAIN LOCATED IN THE MORRISON POUCH, AND DUE TO CONTINUOUS BILE LEAKAGE AN ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERCP) WAS PERFORMED WITH STENT INSERTION INTO THE COMMON BILE DUCT. A FEW DAYS LATER THE LEAK STOPPED, AND THE DRAIN WAS REMOVED AT POST-OPERATIVE DAY 13. AT POST-OPERATIVE DAY 17, THE PATIENT DEVELOPED CHILLS AND AN ELEVATED FEVER. ABDOMINAL CT SCAN REVEALED AN INTRAHEPATIC COLLECTION IN SEGMENT IV, BUT TRANSCUTANEOUS CT GUIDED DRAINAGE DID NOT CONTAIN PUS OR OTHER INFECTED FLUIDS. THE PATIENT CONTINUED TO SUFFER FROM AN ELEVATED FEVER AND ELEVATED WBC COUNT DESPITE WIDE SPECTRUM ANTIBIOTIC ADMINISTRATION. ANOTHER CT SCAN WAS PERFORMED ON POST-OPERATIVE DAY 21, AND IT SHOWED SIMILAR FINDINGS. ANOTHER ATTEMPT OF PERCUTANEOUS DRAINAGE WAS PERFORMED, BUT NO PUS OR OTHER FLUID WAS OBTAINED. THIS WAS FOLLOWED BY A GALLIUM SCAN, WHICH WAS INTERPRETED AS NEGATIVE. GRADUALLY, THE CONDITION OF THE PATIENT IMPROVED, HIS TEMPERATURE NORMALIZED, AND HE WAS DISCHARGED AT POST-OPERATIVE DAY 31. TWO WEEKS LATER, THE PATIENT WAS READMITTED WITH COMPLAINTS OF BILIARY DISCHARGE VIA THE MIDLINE SCAR. AN ABDOMINAL CT FISTULOGRAPHY SCAN REVEALED A HEPATOCUTANEOUS BILIARY FISTULA ORIGINATING FROM THE RIGHT LOBE OF THE LIVER, AND A STRONG SUSPICION OF A FOREIGN BODY. HOWEVER, NO SIGNS OF MARKED PADS WERE OBSERVED. DUE TO THE PRESENCE OF RECURRENT BILIARY FISTULA ORIGINATING FROM THE RIGHT LIVER LOBE, AND HIGH SUSPICION OF GOSSYPIBOMA IN PLACE, THE PATIENT WAS TRANSFERRED TO A TERTIARY MEDICAL CENTER WITH A HEPATOBILIARY DEPARTMENT. THE PATIENT UNDERWENT SURGERY IN WHICH A GRAY ABSCESSLIKE MASS WAS DEMONSTRATED. AFTER THE OPENING OF THE MASS, A FOREIGN BODY SIZED 8 X 3 CM2 WAS RESECTED FROM SEGMENT IV, AND A DRAIN WAS LEFT IN THE PERIHEPATIC SPACE. AFTER THE SURGERY, THE PATIENT WAS UNEVENTFULLY DISCHARGED AT POST-OPERATIVE DAY 9. A FINAL PATHOLOGIC REPORT SHOWED NO TEXTILE IN THE SPECIMEN, AND FINDINGS WERE COMPATIBLE WITH A PIECE OF GEL FORM WITH NO SIGNS OF ABSORPTION. DISCUSSION: THE LIVER IS ONE OF THE MOST COMMONLY INJURED ORGANS IN ABDOMINAL TRAUMA. MOST HEPATIC INJURIES ARE MINOR AND HEAL SPONTANEOUSLY WITH NON-OPERATIVE MANAGEMENT, WHICH CONSISTS OF OBSERVATION AND THE ADJUNCTIVE USE OF ARTERIOGRAPHY AND EMBOLIZATION. A STUDY ON 99 PATIENTS, IN WHOM NON-OPERATIVE MANAGEMENT WAS INITIATED, FOUND ONLY 5% FAILURE OF CONSERVATIVE MANAGEMENT, NOT RELATED TO THE GRADE OF THE INJURY. HOWEVER, OTHER STUDIES REPORT THAT ABOUT 17% OF PATIENTS WITH HEPATIC INJURY WILL REQUIRE SURGICAL INTERVENTION. WHEN SURGERY IS REQUIRED, A SYSTEMATIC APPROACH IS USED TO CONTROL BLEEDING WHILE CONSERVING LIVER PARENCHYMA, HEPATIC RESECTION IS RESERVED FOR SEVERE INJURIES. THE USE OF DAMAGE CONTROL TECHNIQUES DURING THE INITIAL LAPAROTOMY, SPECIFICALLY PERIHEPATIC PACKING, REDUCES THE EXTENT OF SUBSEQUENT SURGICAL PROCEDURES. SEVERAL COMMERCIAL HEMOSTATIC AGENTS ARE READILY AVAILABLE AND CAN BE USED AS AN ADJUNCT AFTER REPAIR OF LIVER INJURIES. THE MOST COMMONLY USED AGENTS ARE GELATIN GELFOAMS, OXIDIZED CELLULOSE, MICROFIBRILLAR COLLAGEN, THROMBIN, THROMBIN WITH GELATIN (\"FLOSEAL\"), AND FIBRIN SEALANT. GELATIN (\"GELFOAM\", \"SURGIFOAM\") IS A HYDROCOLLOID MADE FROM ACID PARTIAL HYDROLYSIS OF PORCINE-DERIVED COLLAGEN THAT IS WHIPPED INTO FOAM AND THEN DRIED. IT IS AVAILABLE IN SPONGE OR POWDER FORM. GELATIN SPONGE ABSORBS BLOOD OR FLUID UP TO 40 TIMES ITS WEIGHT AND CAN EXPAND UP TO 200% IN DIMENSION. THE SPONGE CAN BE LEFT IN PLACE AND SHOULD BE COMPLETELY ABSORBED AFTER FOUR TO SIX WEEKS. THERE ARE SEVERAL REPORTS OF ADVERSE REACTIONS IN THE USE OF GELFOAM. A PHYSICIAN IN HIS REVIEW ON ABSORBABLE HEMOSTATIC AGENTS REPORTED CASES OF ELEVATED FEVER WITHOUT DEMONSTRABLE INFECTION, MOST PROBABLY BECAUSE A PIECE OF GELFOAM MIGHT FORM A NIDUS OF INFECTION AND POTENTIATE BACTERIAL GROWTH. FOREIGN BODY REACTIONS, \"ENCAPSULATION\" OF FLUID, AND HEMATOMA HAVE ALSO BEEN REPORTED. REVIEWING RELEVANT MEDICAL LITERATURE, THE AUTHORS FOUND ONLY ONE CASE OF GELFOAM USE RELATED TO GRANULOMA FORMATION. IN THIS SPECIFIC CASE, A GIANT CELL OCCURRED IN THE BRAIN, MOST PROBABLY DUE TO THE BLOCKAGE OF CEREBROSPINAL FLUID. IN THIS CASE, THE RADIOLOGIC FINDINGS IN THE LIVER WERE INTERPRETED AS AN ABSCESS. THE SUSPICION FOR A FOREIGN BODY WAS RAISED ONLY ON THE SECOND ADMISSION AND THIS FORCED US TO RE-OPERATE ON THE PATIENT. THE AUTHOR CAN ONLY SPECULATE WHY THE PIECE OF GELFOAM WAS NOT ABSORBED IN THAT TIME PERIOD. THE AUTHOR'S OPINION IS THAT POST-ANGIOGRAPHY LIVER ISCHEMIA MAY HAVE DISTURBED THE PROCESS OF FIBRIN DESTRUCTION. THE MAJOR TAKE-HOME MESSAGE IS THAT LACK OF GELFOAM ABSORPTION MAY MIMIC ABDOMINAL FOREIGN BODY, AND THIS NEEDS TO BE CONSIDERED IN LATE POST-OPERATIVE CARE. FOLLOW-UP ((B)(6) 2020): THIS FOLLOW-UP IS FROM THE PRODUCT QUALITY COMPLAINTS GROUP FOR GELFOAM STERILE SPONGE SIZE 50 X 4. DESCRIPTION OF COMPLAINT: PRODUCT COMPLAINT EXCHANGE: [ELEVATED FEVER WITHOUT DEMONSTRABLE INFECTION, MOST PROBABLY BECAUSE A PIECE OF GELFOAM MIGHT FORM A NIDUS OF INFECTION AND POTENTIATE BACTERIAL GROWTH]. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION WITH SEVERITY OF HARM S4. THE ROOT CAUSE ANALYSIS INDICATED THAT THE PFIZER SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. THE SAMPLE AVAILABILITY STATUS WAS UNKNOWN. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. A MEDICAL DEVICE TREND ANALYSIS WAS COMPLETED AND WAS ACCEPTABLE. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, IT WAS REPORTED POSTOPERATIVE REBLEEDING AND BILE LEAKAGE. THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED SERIOUS EVENT OF \"HEPATOCUTANEOUS BILIARY FISTULA ORIGINATING FROM THE RIGHT LIVER LOBE\" WAS CONSIDERED AS A VERY RARE COMPLICATION WHILE USING GELFOAM FOR HEPATIC BLEEDING DUE TO LIVER TRAUMA. THE PIECE OF GELFOAM WAS NOT ABSORBED IN THAT TIME PERIOD, AND THE AUTHOR SPECULATED THE REASON WAS DUE TO POST-ANGIOGRAPHY LIVER ISCHEMIA WHICH MAY HAVE DISTURBED THE PROCESS OF FIBRIN DESTRUCTION. THE COMPANY CONDUCTED PRODUCT QUALITY INVESTIGATION AND NO ROOT CAUSE WAS IDENTIFIED. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED.Z, COMMENT: THE REPORTED SERIOUS EVENT OF \"HEPATOCUTANEOUS BILIARY FISTULA ORIGINATING FROM THE RIGHT LIVER LOBE\" WAS CONSIDERED AS A VERY RARE COMPLICATION WHILE USING GELFOAM FOR HEPATIC BLEEDING DUE TO LIVER TRAUMA. THE PIECE OF GELFOAM WAS NOT ABSORBED IN THAT TIME PERIOD, AND THE AUTHOR SPECULATED THE REASON WAS DUE TO POST-ANGIOGRAPHY LIVER ISCHEMIA WHICH MAY HAVE DISTURBED THE PROCESS OF FIBRIN DESTRUCTION. THE COMPANY CONDUCTED PRODUCT QUALITY INVESTIGATION AND NO ROOT CAUSE WAS IDENTIFIED. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS." }, { "mdr_text_key": "200980099", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A PIECE OF GEL FORM WITH NO SIGNS OF ABSORPTION/THE PIECE OF GELFOAM WAS NOT ABSORBED IN THAT TIME PERIOD [DEVICE ISSUE], HEPATOCUTANEOUS BILIARY FISTULA ORIGINATING FROM THE RIGHT LIVER LOBE [BILIARY FISTULA], NARRATIVE: THIS IS A LITERATURE-SPONTANEOUS REPORT FROM THE JOURNAL OF ENDOVASCULAR RESUSCITATION AND TRAUMA MANAGEMENT, 2019, VOL. 3, NO. 2, PAGES 77-79 ENTITLED \"GOSSYPIBOMA: IS IT ALWAYS WHAT IT APPEARS TO BE? A RARE COMPLICATION IN EVERYDAY PRACTICE\". THE LIVER IS ONE OF THE MOST COMMONLY INJURED ORGANS IN ABDOMINAL TRAUMA. MOST CASES OF HEPATIC INJURIES ARE MANAGED CONSERVATIVELY WITH A SUCCESS RATE OF 90%. IN CASES WHICH REQUIRE SURGERY, DIFFERENT TECHNIQUES ARE DESCRIBED FOR HEMOSTASIS. SEVERAL COMMERCIAL HEMOSTATIC AGENTS ARE READILY AVAILABLE AND CAN BE USED AS AN ADJUNCT AFTER THE REPAIR OF LIVER INJURIES. ONE OF THE MOST WELL-KNOWN LOCAL AGENTS IS ABSORBABLE GELATIN (GELFOAM), WHICH IS USED IN MULTIPLE FIELDS OF SURGERY. HERE THE AUTHORS WE PRESENT A CASE OF A VERY RARE COMPLICATION WHILE USING GELFOAM, MIMICKING GOSSYPIBOMA. A (B)(6)-YEAR-OLD MALE PATIENT WAS ADMITTED TO THE TRAUMA UNIT AFTER BEING STABBED IN THE LOWER SEGMENT OF HIS RIGHT CHEST. HE ALSO HAD ADDITIONAL MULTIPLE STAB WOUNDS TO THE BACK, AND UPPER AND LOWER EXTREMITIES. ON ADMISSION, THE PATIENT LOOKED PALE AND AGITATED, HIS INITIAL BLOOD PRESSURE WAS 80/40, PULSE OVER 130 PER MINUTE. ON AUSCULTATION, BREATH SOUNDS WERE SLIGHTLY DIMINISHED ON THE RIGHT, WHERE A WOUND WITH EVISCERATION OF OMENTUM WAS SEEN 3 CM ABOVE THE RIGHT CHEST CAGE. AFTER INSERTION OF A CHEST TUBE INTO THE RIGHT THORAX, AND EVACUATION OF A SMALL AMOUNT OF AIR AND BLOOD, THE PATIENT WAS THEN IMMEDIATELY TAKEN TO THE OPERATING ROOM. DURING SURGERY, 1.5 L OF BLOOD WERE FOUND INSIDE THE ABDOMINAL CAVITY, A DEEP LIVER, SEGMENT IV, LACERATION WAS DEMONSTRATED, WITH ACTIVE ARTERIAL BLEEDING. IN ADDITION, A 3 CM DIAPHRAGMATIC TEAR WAS ALSO DEMONSTRATED. THE BLEEDING FROM THE LIVER WAS STOPPED BY THE INSERTION OF A PIECE OF GELFOAM INTO THE WOUND AND BY SUTURING OF THE LIVER ABOVE IN ORDER TO CREATE A LOCAL TAMPONADE EFFECT. THE PROCEDURE WAS COMPLETED WITH FORMAL LIVER PACKING, DIAPHRAGM REPAIR, AND THE ABDOMEN WAS CLOSED WITH A BOGOTA BAG, AS IS ACCEPTABLE IN \"DAMAGE CONTROL\". IN THE POST-SURGERY PERIOD, THE PATIENT WAS STABLE AND WAS THEN TRANSFERRED TO THE ANGIOGRAPHIC UNIT. ON ANGIOGRAPHY, EXTRAVASATION WAS DEMONSTRATED FROM ONE OF THE INTRAHEPATIC ARTERIES, AND SUCCESSFUL ANGIOEMBOLIZATION WAS ACHIEVED. FORTY-EIGHT HOURS LATER, A RELAPAROTOMY WAS PERFORMED AND THE LIVER PACKING WAS REMOVED. NO BLEEDING OR BILE LEAKAGE WERE OBSERVED, DRAINS WERE LEFT INSIDE THE ABDOMEN, AND THE ABDOMEN WAS SUTURED CLOSED. IN ADDITION, ALL SURGICAL INSTRUMENTS AND TAGGED PADS WERE ACCOUNTED FOR. AT POST-OPERATIVE DAY 6, AFTER THE SECOND OPERATION, BILE LEAKAGE WAS VISUALIZED IN A DRAIN LOCATED IN THE MORRISON POUCH, AND DUE TO CONTINUOUS BILE LEAKAGE AN ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERCP) WAS PERFORMED WITH STENT INSERTION INTO THE COMMON BILE DUCT. A FEW DAYS LATER THE LEAK STOPPED, AND THE DRAIN WAS REMOVED AT POST-OPERATIVE DAY 13. AT POST-OPERATIVE DAY 17, THE PATIENT DEVELOPED CHILLS AND AN ELEVATED FEVER. ABDOMINAL CT SCAN REVEALED AN INTRAHEPATIC COLLECTION IN SEGMENT IV, BUT TRANSCUTANEOUS CT GUIDED DRAINAGE DID NOT CONTAIN PUS OR OTHER INFECTED FLUIDS. THE PATIENT CONTINUED TO SUFFER FROM AN ELEVATED FEVER AND ELEVATED WBC COUNT DESPITE WIDE SPECTRUM ANTIBIOTIC ADMINISTRATION. ANOTHER CT SCAN WAS PERFORMED ON POST-OPERATIVE DAY 21, AND IT SHOWED SIMILAR FINDINGS. ANOTHER ATTEMPT OF PERCUTANEOUS DRAINAGE WAS PERFORMED, BUT NO PUS OR OTHER FLUID WAS OBTAINED. THIS WAS FOLLOWED BY A GALLIUM SCAN, WHICH WAS INTERPRETED AS NEGATIVE. GRADUALLY, THE CONDITION OF THE PATIENT IMPROVED, HIS TEMPERATURE NORMALIZED, AND HE WAS DISCHARGED AT POST-OPERATIVE DAY 31. TWO WEEKS LATER, THE PATIENT WAS READMITTED WITH COMPLAINTS OF BILIARY DISCHARGE VIA THE MIDLINE SCAR. AN ABDOMINAL CT FISTULOGRAPHY SCAN REVEALED A HEPATOCUTANEOUS BILIARY FISTULA ORIGINATING FROM THE RIGHT LOBE OF THE LIVER, AND A STRONG SUSPICION OF A FOREIGN BODY. HOWEVER, NO SIGNS OF MARKED PADS WERE OBSERVED. DUE TO THE PRESENCE OF RECURRENT BILIARY FISTULA ORIGINATING FROM THE RIGHT LIVER LOBE, AND HIGH SUSPICION OF GOSSYPIBOMA IN PLACE, THE PATIENT WAS TRANSFERRED TO A TERTIARY MEDICAL CENTER WITH A HEPATOBILIARY DEPARTMENT. THE PATIENT UNDERWENT SURGERY IN WHICH A GRAY ABSCESS-LIKE MASS WAS DEMONSTRATED. AFTER THE OPENING OF THE MASS, A FOREIGN BODY SIZED 8 X 3 CM2 WAS RESECTED FROM SEGMENT IV, AND A DRAIN WAS LEFT IN THE PERIHEPATIC SPACE. AFTER THE SURGERY, THE PATIENT WAS UNEVENTFULLY DISCHARGED AT POST-OPERATIVE DAY 9. A FINAL PATHOLOGIC REPORT SHOWED NO TEXTILE IN THE SPECIMEN, AND FINDINGS WERE COMPATIBLE WITH A PIECE OF GEL FORM WITH NO SIGNS OF ABSORPTION. DISCUSSION: THE LIVER IS ONE OF THE MOST COMMONLY INJURED ORGANS IN ABDOMINAL TRAUMA. MOST HEPATIC INJURIES ARE MINOR AND HEAL SPONTANEOUSLY WITH NON-OPERATIVE MANAGEMENT, WHICH CONSISTS OF OBSERVATION AND THE ADJUNCTIVE USE OF ARTERIOGRAPHY AND EMBOLIZATION. A STUDY ON 99 PATIENTS, IN WHOM NON-OPERATIVE MANAGEMENT WAS INITIATED, FOUND ONLY 5% FAILURE OF CONSERVATIVE MANAGEMENT, NOT RELATED TO THE GRADE OF THE INJURY. HOWEVER, OTHER STUDIES REPORT THAT ABOUT 17% OF PATIENTS WITH HEPATIC INJURY WILL REQUIRE SURGICAL INTERVENTION. WHEN SURGERY IS REQUIRED, A SYSTEMATIC APPROACH IS USED TO CONTROL BLEEDING WHILE CONSERVING LIVER PARENCHYMA, HEPATIC RESECTION IS RESERVED FOR SEVERE INJURIES. THE USE OF DAMAGE CONTROL TECHNIQUES DURING THE INITIAL LAPAROTOMY, SPECIFICALLY PERIHEPATIC PACKING, REDUCES THE EXTENT OF SUBSEQUENT SURGICAL PROCEDURES. SEVERAL COMMERCIAL HEMOSTATIC AGENTS ARE READILY AVAILABLE AND CAN BE USED AS AN ADJUNCT AFTER REPAIR OF LIVER INJURIES. THE MOST COMMONLY USED AGENTS ARE GELATIN GELFOAMS, OXIDIZED CELLULOSE, MICROFIBRILLAR COLLAGEN, THROMBIN, THROMBIN WITH GELATIN (\"FLOSEAL\"), AND FIBRIN SEALANT. GELATIN (\"GELFOAM\", \"SURGIFOAM\") IS A HYDROCOLLOID MADE FROM ACID PARTIAL HYDROLYSIS OF PORCINE-DERIVED COLLAGEN THAT IS WHIPPED INTO FOAM AND THEN DRIED. IT IS AVAILABLE IN SPONGE OR POWDER FORM. GELATIN SPONGE ABSORBS BLOOD OR FLUID UP TO 40 TIMES ITS WEIGHT AND CAN EXPAND UP TO 200% IN DIMENSION. THE SPONGE CAN BE LEFT IN PLACE AND SHOULD BE COMPLETELY ABSORBED AFTER FOUR TO SIX WEEKS. THERE ARE SEVERAL REPORTS OF ADVERSE REACTIONS IN THE USE OF GELFOAM. A PHYSICIAN IN HIS REVIEW ON ABSORBABLE HEMOSTATIC AGENTS REPORTED CASES OF ELEVATED FEVER WITHOUT DEMONSTRABLE INFECTION, MOST PROBABLY BECAUSE A PIECE OF GELFOAM MIGHT FORM A NIDUS OF INFECTION AND POTENTIATE BACTERIAL GROWTH. FOREIGN BODY REACTIONS, \"ENCAPSULATION\" OF FLUID, AND HEMATOMA HAVE ALSO BEEN REPORTED. REVIEWING RELEVANT MEDICAL LITERATURE, THE AUTHORS FOUND ONLY ONE CASE OF GELFOAM USE RELATED TO GRANULOMA FORMATION. IN THIS SPECIFIC CASE, A GIANT CELL OCCURRED IN THE BRAIN, MOST PROBABLY DUE TO THE BLOCKAGE OF CEREBROSPINAL FLUID. IN THIS CASE, THE RADIOLOGIC FINDINGS IN THE LIVER WERE INTERPRETED AS AN ABSCESS. THE SUSPICION FOR A FOREIGN BODY WAS RAISED ONLY ON THE SECOND ADMISSION AND THIS FORCED US TO RE-OPERATE ON THE PATIENT. THE AUTHOR CAN ONLY SPECULATE WHY THE PIECE OF GELFOAM WAS NOT ABSORBED IN THAT TIME PERIOD. THE AUTHOR'S OPINION IS THAT POST-ANGIOGRAPHY LIVER ISCHEMIA MAY HAVE DISTURBED THE PROCESS OF FIBRIN DESTRUCTION. THE MAJOR TAKE-HOME MESSAGE IS THAT LACK OF GELFOAM ABSORPTION MAY MIMIC ABDOMINAL FOREIGN BODY, AND THIS NEEDS TO BE CONSIDERED IN LATE POST-OPERATIVE CARE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, IN THIS CASE PATIENT WAS ADMITTED TO THE TRAUMA UNIT AFTER BEING STABBED IN THE LOWER SEGMENT OF HIS RIGHT CHEST. HE ALSO HAD ADDITIONAL MULTIPLE STAB WOUNDS TO THE BACK, AND UPPER AND LOWER EXTREMITIES. AS NOTED IN THIS REPORT, A GIANT CELL OCCURRED IN THE BRAIN, MOST PROBABLY DUE TO THE BLOCKAGE OF CEREBROSPINAL FLUID. THE RADIOLOGIC FINDINGS IN THE LIVER WERE INTERPRETED AS AN ABSCESS. AN ABDOMINAL CT FISTULOGRAPHY SCAN REVEALED A HEPATOCUTANEOUS BILIARY FISTULA ORIGINATING FROM THE RIGHT LOBE OF THE LIVER, AND A STRONG SUSPICION OF A FOREIGN BODY. DUE TO THE PRESENCE OF RECURRENT BILIARY FISTULA ORIGINATING FROM THE RIGHT LIVER LOBE, AND HIGH SUSPICION OF GOSSYPIBOMA, THIS PATIENT WAS TRANSFERRED TO A TERTIARY MEDICAL CENTER WITH A HEPATOBILIARY DEPARTMENT. PATIENT UNDERWENT SURGERY IN WHICH A GRAY ABSCESS LIKE MASS WAS DEMONSTRATED. AFTER THE OPENING OF THE MASS, A FOREIGN BODY SIZE 8 X 3 CM2 WAS RESECTED FROM SEGMENT IV, AND A DRAIN WAS LEFT IN THE PERIHEPATIC SPACE. AFTER THE SURGERY, THE PATIENT WAS UNEVENTFULLY DISCHARGED AT POST-OPERATIVE DAY 9. A FINAL PATHOLOGIC REPORT WERE COMPATIBLE WITH A PIECE OF GEL FORM WITH NO SIGNS OF ABSORPTION. THE SUSPICION FOR A FOREIGN BODY WAS RAISED ONLY ON THE SECOND ADMISSION AND THE PATIENT WAS RE-OPERATED. THE AUTHOR SPECULATED THE REASON PIECE OF GELFOAM WAS NOT ABSORBED DUE TO POST-ANGIOGRAPHY LIVER ISCHEMIA WHICH MAY HAVE DISTURBED THE PROCESS OF FIBRIN DESTRUCTION. HENCE, LACK OF GELFOAM ABSORPTION MAY MIMIC ABDOMINAL FOREIGN BODY, AND SHOULD BE CONSIDERED IN LATE POST-OPERATIVE CARE. CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED, IN THIS CASE PATIENT WAS ADMITTED TO THE TRAUMA UNIT AFTER BEING STABBED IN THE LOWER SEGMENT OF HIS RIGHT CHEST. HE ALSO HAD ADDITIONAL MULTIPLE STAB WOUNDS TO THE BACK, AND UPPER AND LOWER EXTREMITIES. AS NOTED IN THIS REPORT, A GIANT CELL OCCURRED IN THE BRAIN, MOST PROBABLY DUE TO THE BLOCKAGE OF CEREBROSPINAL FLUID. THE RADIOLOGIC FINDINGS IN THE LIVER WERE INTERPRETED AS AN ABSCESS. AN ABDOMINAL CT FISTULOGRAPHY SCAN REVEALED A HEPATOCUTANEOUS BILIARY FISTULA ORIGINATING FROM THE RIGHT LOBE OF THE LIVER, AND A STRONG SUSPICION OF A FOREIGN BODY. DUE TO THE PRESENCE OF RECURRENT BILIARY FISTULA ORIGINATING FROM THE RIGHT LIVER LOBE, AND HIGH SUSPICION OF GOSSYPIBOMA, THIS PATIENT WAS TRANSFERRED TO A TERTIARY MEDICAL CENTER WITH A HEPATOBILIARY DEPARTMENT. PATIENT UNDERWENT SURGERY IN WHICH A GRAY ABSCESS LIKE MASS WAS DEMONSTRATED. AFTER THE OPENING OF THE MASS, A FOREIGN BODY SIZE 8 X 3 CM2 WAS RESECTED FROM SEGMENT IV, AND A DRAIN WAS LEFT IN THE PERIHEPATIC SPACE. AFTER THE SURGERY, THE PATIENT WAS UNEVENTFULLY DISCHARGED AT POST-OPERATIVE DAY 9. A FINAL PATHOLOGIC REPORT WERE COMPATIBLE WITH A PIECE OF GEL FORM WITH NO SIGNS OF ABSORPTION. THE SUSPICION FOR A FOREIGN BODY WAS RAISED ONLY ON THE SECOND ADMISSION AND THE PATIENT WAS RE-OPERATED. THE AUTHOR SPECULATED THE REASON PIECE OF GELFOAM WAS NOT ABSORBED DUE TO POST-ANGIOGRAPHY LIVER ISCHEMIA WHICH MAY HAVE DISTURBED THE PROCESS OF FIBRIN DESTRUCTION. HENCE, LACK OF GELFOAM ABSORPTION MAY MIMIC ABDOMINAL FOREIGN BODY, AND SHOULD BE CONSIDERED IN LATE POST-OPERATIVE CARE. CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/25/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04254", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200512", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20161128", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200512", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200512", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/15/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200512", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200731", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10049164", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200423", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190755469", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT AND IMPLANT: ESTIMATED DATE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE SCAFFOLD WAS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION." }, { "mdr_text_key": "190755470", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CASE REPORT WAS IDENTIFIED THROUGH AN ARTICLE, \u00bfA CASE REPORT OF A RECURRENT EARLY AND LATE BIORESORBABLE VASCULAR SCAFFOLD THROMBOSIS: SERIAL ANGIOGRAPHY AND OPTICAL COHERENCE TOMOGRAPHY FINDINGS\u00bf. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI). PER IMAGING THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY HAD A TOTAL OCCLUSION. AFTER PRE-DILATATION, A 2.5X28MM ABSORB GT1 SCAFFOLD WAS IMPLANTED. ACUTE MALAPPOSITION, LIKELY DUE TO SCAFFOLD UNDER-SIZING, WAS OBSERVED AND POST-DILATATION WAS PERFORMED. AFTER, THE MALAPPOSITION WAS NO LONGER SIGNIFICANT. ASPIRIN AND CLOPIDOGREL WERE PRESCRIBED AND THE PATIENT WAS DISCHARGED. 16 DAYS LATER, THE PATIENT STOPPED TAKING ASPIRIN AND CLOPIDOGREL DUE TO A COLONOSCOPY. 20 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN. AN NSTEMI WAS DIAGNOSED AND MID SCAFFOLD THROMBOSIS OBSERVED. BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT. THE PATIENT WAS PRESCRIBED ASPIRIN AND TICAGRELOR AT DISCHARGE. 1 YEAR FOLLOW-UP, MILD STENOSIS MID-SCAFFOLD WAS OBSERVED, ALONG WITH PERI-STRUT LOW INTENSITY AREA (PLIA) AT THE PROXIMAL SCAFFOLD. THE MINIMAL LUMEN AREA (MLA) WAS 2.66MM2 AND NEOINTIMAL HYPERPLASIA WAS 55% WITHOUT SYMPTOMS ASSOCIATED. MEDICATION (ASPIRIN AND CLOPIDOGREL) WAS CONTINUED. 2-YEARS AFTER BVS IMPLANTATION, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN AT REST. A ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) WAS DIAGNOSED. PER IMAGING, LATE SCAFFOLD THROMBOSIS WITHIN THE PROXIMAL SCAFFOLD PORTION AND WITHIN AT THE SAME AREA AS THE PLIA, AND DISRUPTED SCAFFOLD STRUTS WERE ALSO OBSERVED. BALLOON ANGIOPLASTY WAS PERFORMED AND A 2.75X33MM XIENCE ALPINE STENT WAS IMPLANTED, COVERING THE ENTIRE SCAFFOLD SEGMENT. IMAGING SHOWED GOOD APPOSITION AS THE INTRA-LUMINAL DISMANTLED BVS STRUTS WERE COMPRESSED TOWARDS THE VESSEL WALL. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE." }, { "mdr_text_key": "318886258", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3, D6: ESTIMATED. D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THIS REPORT IS BEING RE-SUBMITTED TO PROVIDE THE ATTACHMENT BELOW AGAIN: ATTACHMENT: LITERATURE TITLED \"A CASE REPORT OF A RECURRENT EARLY AND LATE BIORESORBABLE VASCULAR SCAFFOLD THROMBOSIS: SERIAL ANGIOGRAPHY AND OPTICAL COHERENCE TOMOGRAPHY FINDINGS.\"NA - ATTACHMENT: [E-25913 ARTICLE NMS.PDF]." }, { "mdr_text_key": "316320892", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, RESTENOSIS AND ANGINA, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/29/2020;07/31/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1810189-2020-00049", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200514", "manufacturer_address_2": "", "pma_pmn_number": "18-286", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "CONSUM" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200514", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200514", "brand_name": "GELFOAM", "generic_name": "SPONGE, STERILE; CLASS III", "manufacturer_d_name": "PFIZER, INC.", "manufacturer_d_address_1": "235 EAST 42 STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "NEW YORK", "manufacturer_d_state": "NY", "manufacturer_d_zip_code": "10017", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "10017", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "LMF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "1810189" ], "fei_number": [ "1810189" ], "device_name": "Agent, Absorbable Hemostatic, Collagen Based", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4490", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "manufacturer_contact_country": "", "date_changed": "20230818", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Perforation", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200507", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10057200", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321413131", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REASONABLY SUGGEST DEVICE MALFUNCTION: YES. SEVERITY OF HARM: S5. SITE SAMPLE STATUS: NOT RECEIVED. ROOT CAUSE: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE KALAMAZOO MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE." }, { "mdr_text_key": "321413132", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "EVENT VERBATIM [PREFERRED TERM]. ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE [OFF LABEL USE], ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE [PRODUCT USE IN UNAPPROVED INDICATION], SOME OF THE ABSORBABLE GELATIN REACHED ANOTHER BLOOD VESSEL. SINCE A LARGE AMOUNT OF ABSORBABLE GELATIN WAS USED FOR HEMOSTASIS, BACKFLOW OCCURRED AND IT ADHERED TO THE STENT. SO ABSORBABLE GELATIN WAS INHALED, BUT IT COULD NOT REMOVE EVERYTHING. [VASCULAR STENT THROMBOSIS], , NARRATIVE: A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR HAEMOSTASIS. MEDICAL HISTORY INCLUDED ONGOING VESSEL PERFORATION. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, SINCE CARDIOVASCULAR OF PATIENT EXPERIENCED VESSEL PERFORATION AND THE BLOOD BEGAN TO OVERFLOW, ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE. DUE TO THE LARGE AMOUNT USED, SOME OF THE ABSORBABLE GELATIN REACHED ANOTHER BLOOD VESSEL. PERFORATION OCCURRED DURING THE TREATMENT USING A STENT BY THE CARDIOLOGIST. SINCE A LARGE AMOUNT OF ABSORBABLE GELATIN WAS USED FOR HEMOSTASIS, BACKFLOW OCCURRED AND IT ADHERED TO THE STENT. SO ABSORBABLE GELATIN WAS INHALED, BUT IT COULD NOT REMOVE EVERYTHING. THE OUTCOME OF EVENT WAS UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. ON (B)(6)2020, THE PRODUCT QUALITY COMPLAINT GROUP PROVIDED THE FOLLOWING INVESTIGATION RESULTS THAT YIELDED NO PRODUCT QUALITY ISSUES. PRODUCT: GELFOAM STERILE SPONGE. LOT NUMBER AND EXPIRATION DATE: NOT AVAILABLE. DESCRIPTION OF COMPLIANT: ABSORBABLE GELATIN WAS ADMINISTERED TO INTRAVASCULAR AT OVERDOSE AS OFF LABEL USE. REASONABLY SUGGEST DEVICE MALFUNCTION: YES. SEVERITY OF HARM: S5. SITE SAMPLE STATUS: NOT RECEIVED. ROOT CAUSE: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE KALAMAZOO MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE OR THE PRODUCT WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. A PRELIMINARY INVESTIGATION WAS NOT PERFORMED FOR THE REPORTED COMPLAINT. THE COMPLAINT WAS RECEIVED AS A NORMAL PRIORITY COMPLAINT, AND TWO WEEKS INTO INVESTIGATION, THE PRIORITY WAS UPDATED TO EXPEDITE. THERE IS NO IMPACT TO QUALITY. NOTIFICATION TO THE MDCP TEAM WAS PERFORMED WITHIN PROCEDURALLY REQUIRED TIMELINES. THE DCHU WAS NOTIFIED OF PREVIOUS MDR RELATED TO THE REPORTED COMPLAINT WITHIN THE REQUIRED TIMEFRAME. ADDITIONAL INFORMATION WAS NOT PROVIDED AT THE TIME THE UPDATE TO EXPEDITE WAS MADE THAT WOULD HAVE IMPACTED THE ONGOING COMPLAINT INVESTIGATION FOR THE REPORTED COMPLAINT. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER KALAMAZOO IS NOT REQUIRED. LOT-SPECIFIC TREND IDENTIFIED: NO. A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF \"ABSORBABLE MATERIAL'\" WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF \"DELIVERY SYSTEM\" WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF \"PRODUCT USE ATTRIBUTES\". THERE WAS ONE MONTH ((B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (4); HOWEVER, THIS WAS DUE TO A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF \"PRODUCT USE ATTRIBUTES DEFECT NOT CLASSIFIED\", AND THE COMPLAINTS WERE WITHIN NORMAL AND EXPECTED RANGES. NO TREND WAS IDENTIFIED REGARDING THE REPORTED SUB-CLASS. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. FINAL CONFIRMATION STATUS: NOT CONFIRMED. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: TO UPDATE DECHALLENGE/ RECHALLENGE RESULT AND UNCHECK PRODUCT PROBLEM FIELD. FOLLOW-UPS (01OCT2020): NEW INFORMATION FROM PRODUCT COMPLAINT GROUP INCLUDES INVESTIGATION RESULTS." }, { "mdr_text_key": "318574364", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "EVENT VERBATIM [PREFERRED TERM]: ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE [OFF LABEL USE], ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE [PRODUCT USE IN UNAPPROVED INDICATION], SOME OF THE ABSORBABLE GELATIN REACHED ANOTHER BLOOD VESSEL. SINCE A LARGE AMOUNT OF ABSORBABLE GELATIN WAS USED FOR HEMOSTASIS, BACKFLOW OCCURRED AND IT ADHERED TO THE STENT. SO ABSORBABLE GELATIN WAS INHALED, BUT IT COULD NOT REMOVE EVERYTHING. [VASCULAR STENT THROMBOSIS]. NARRATIVE: A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR HAEMOSTASIS. MEDICAL HISTORY INCLUDED ONGOING VESSEL PERFORATION. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, SINCE CARDIOVASCULAR OF PATIENT EXPERIENCED VESSEL PERFORATION AND THE BLOOD BEGAN TO OVERFLOW, ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE. DUE TO THE LARGE AMOUNT USED, SOME OF THE ABSORBABLE GELATIN REACHED ANOTHER BLOOD VESSEL. PERFORATION OCCURRED DURING THE TREATMENT USING A STENT BY THE CARDIOLOGIST. SINCE A LARGE AMOUNT OF ABSORBABLE GELATIN WAS USED FOR HEMOSTASIS, BACKFLOW OCCURRED AND IT ADHERED TO THE STENT. SO ABSORBABLE GELATIN WAS INHALED, BUT IT COULD NOT REMOVE EVERYTHING. THE OUTCOME OF EVENT WAS UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: TO UPDATE DECHALLENGE/ RECHALLENGE RESULT AND UNCHECK PRODUCT PROBLEM FIELD." }, { "mdr_text_key": "201211786", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE [OFF LABEL USE], ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE [PRODUCT USE IN UNAPPROVED INDICATION], SOME OF THE ABSORBABLE GELATIN REACHED ANOTHER BLOOD VESSEL. SINCE A LARGE AMOUNT OF ABSORBABLE GELATIN WAS USED FOR HEMOSTASIS, BACKFLOW OCCURRED AND IT ADHERED TO THE STENT. SO ABSORBABLE GELATIN WAS INHALED, BUT IT COULD NOT REMOVE EVERYTHING. [VASCULAR STENT THROMBOSIS]. NARRATIVE: A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT AN UNSPECIFIED DOSE FOR HAEMOSTASIS. MEDICAL HISTORY INCLUDED ONGOING VESSEL PERFORATION. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, SINCE CARDIOVASCULAR OF PATIENT EXPERIENCED VESSEL PERFORATION AND THE BLOOD BEGAN TO OVERFLOW, ABSORBABLE GELATIN WAS USED FOR CARDIOVASCULAR, ALTHOUGH IT WAS OFF LABEL USE. DUE TO THE LARGE AMOUNT USED, SOME OF THE ABSORBABLE GELATIN REACHED ANOTHER BLOOD VESSEL. PERFORATION OCCURRED DURING THE TREATMENT USING A STENT BY THE CARDIOLOGIST. SINCE A LARGE AMOUNT OF ABSORBABLE GELATIN WAS USED FOR HEMOSTASIS, BACKFLOW OCCURRED AND IT ADHERED TO THE STENT. SO ABSORBABLE GELATIN WAS INHALED, BUT IT COULD NOT REMOVE EVERYTHING. THE OUTCOME OF EVENT WAS UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/15/2020;10/15/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04296", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200514", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200514", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200514", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230627", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10057569", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190983243", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH. EVENT, AND IMPLANT: ESTIMATED DATES. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF DEATH IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "190983244", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING; DEATH, MYOCARDIAL INFARCTION, SCAFFOLD THROMBOSIS, TARGET LESION REVASCULARIZATION, TARGET VESSEL REVASCULARIZATION AND RE-HOSPITALIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"TWO YEAR EFFICACY AND SAFETY OF SMALL VERSUS LARGE ABSORB BIORESORBABLE VASCULAR SCAFFOLDS OF =18 MM DEVICE LENGTH: A SUBGROUP ANALYSIS OF THE (B)(6) REGISTRY ((B)(6))\"." }, { "mdr_text_key": "315183528", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04298", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200514", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200514", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200514", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10057657", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318844736", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "191403366", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF EVENT AND IMPLANT: ESTIMATED DATES. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "191403367", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING; DEATH, MYOCARDIAL INFARCTION, SCAFFOLD THROMBOSIS, TARGET LESION REVASCULARIZATION, TARGET VESSEL REVASCULARIZATION AND RE-HOSPITALIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"TWO YEAR EFFICACY AND SAFETY OF SMALL VERSUS LARGE ABSORB BIORESORBABLE VASCULAR SCAFFOLDS OF =18 MM DEVICE LENGTH: A SUBGROUP ANALYSIS OF THE GERMAN-AUSTRIAN ABSORB REGISTRY (GABI-R)\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04334", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200514", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200514", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200514", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/13/2020", "manufacturer_contact_country": "", "date_changed": "20230814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200514", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Occlusion", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10059831", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200508", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318768546", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: MEAN AGE. B3, D6: ESTIMATED DATES. D4: THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF THROMBOSIS, RESTENOSIS AND OCCLUSION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE WAS NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT WAS SIMILAR TO A DEVICE SOLD IN THE U.S. LITERATURE ATTACHMENT: \u00bfPERI-STRUT LOW INTENSITY AREAS AND IN-SCAFFOLD NEOINTIMA GROWTH AFTER BIORESORBABLE SCAFFOLD IMPLANTATION IN STEMI. A SERIAL OPTICAL COHERENCE TOMOGRAPHY STUDY.\u00bf" }, { "mdr_text_key": "191076028", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WILL NOT RETURN FOR ANALYSIS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION. THE ABSORB DEVICE WAS NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT WAS SIMILAR TO A DEVICE SOLD IN THE U.S. LITERATURE: \u00bfPERI-STRUT LOW INTENSITY AREAS AND IN-SCAFFOLD NEOINTIMA GROWTH AFTER BIORESORBABLE SCAFFOLD IMPLANTATION IN STEMI. A SERIAL OPTICAL COHERENCE TOMOGRAPHY STUDY\u00bf (B)(4)." }, { "mdr_text_key": "191076029", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD MAY BE RELATED TO PERI-STRUT LOW INTENSITY AREAS (PSLA)S, IN SCAFFOLD NEOINTIMA GROWTH (NEOATHEROSCLEROSIS, NEOVASCULARIZATION, THIN-CAPPED FIBROATHEROMA, CALCIUM, PLAQUE/LIPIDS AND MACROPHAGES), THROMBOSIS, RESTENOSIS, TOTAL OCCLUSION, AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \u00bfPERI-STRUT LOW INTENSITY AREAS AND IN-SCAFFOLD NEOINTIMA GROWTH AFTER BIORESORBABLE SCAFFOLD IMPLANTATION IN STEMI. A SERIAL OPTICAL COHERENCE TOMOGRAPHY STUDY\u00bf." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1810189-2020-00040", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200519", "manufacturer_address_2": "", "pma_pmn_number": "18-286", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "LITERATUR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200519", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200519", "brand_name": "GELFOAM", "generic_name": "SPONGE, STERILE; CLASS III", "manufacturer_d_name": "PFIZER, INC. (DEVICE)", "manufacturer_d_address_1": "7000 PORTAGE ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "KALAMAZOO, MI", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "I", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "LMF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "1810189" ], "fei_number": [ "1810189" ], "device_name": "Agent, Absorbable Hemostatic, Collagen Based", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4490", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/06/2020", "manufacturer_contact_country": "", "date_changed": "20230802", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200519", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Ischemia" ] } ], "distributor_city": "", "date_report": "20200429", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10071743", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200429", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320210583", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "EVENT VERBATIM [PREFERRED TERM] LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY) CASE SERIES USING GELATIN SPONGE [OFF LABEL USE], LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY) CASE SERIES USING GELATIN SPONGE [PRODUCT USE IN UNAPPROVED INDICATION], REBLEEDING [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], ISCHEMIC BOWEL [GASTROINTESTINAL ISCHAEMIA], SPLENIC INFARCTION [SPLENIC INFARCTION]. NARRATIVE: THIS CASE HAS BEEN CONSIDERED INVALID BASED ON RECEIPT OF THE FULL PUBLICATION ON (B)(6) 2020, IT WAS REPORTED THAT THE SUSPECT DRUG WAS A NON-PFIZER DRUG. THIS IS A LITERATURE REPORT FROM THE JOURNAL OF EUR RADIOL; 2000; 10(5); 802-5, ENTITLED, ' EMBOLIZATION FOR GASTROINTESTINAL HEMORRHAGES,' WHICH WAS REFERENCED IN ACG CASE REPORTS JOURNAL, 2019, ENTITLED, 'MANAGEMENT OF HEMODYNAMIC COLLAPSE AFTER LIVER TRANSPLANTATION FROM NATIVE BILE DUCT STUMP HEMORRHAGE WITH GELFOAM.' A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY). THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS REPORTED LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY) CASE SERIES USING GELATIN SPONGE SUSPENSION REPORT ADVERSE EVENTS OF REBLEEDING, ISCHEMIC BOWEL, AND PARTIAL SPLENIC INFARCTION, ALTHOUGH THESE DO NOT DISTINGUISH BETWEEN PATIENTS WHO RECEIVED GELFOAM AND OTHER HEMOSTATIC AGENTS OR COILS. THE PATIENT EXPERIENCED REBLEEDING, ISCHEMIC BOWEL, SPLENIC INFARCTION, ALL ON AN UNSPECIFIED DATE WITH OUTCOME OF UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR ABSORBABLE GELATIN WAS UNKNOWN. FOLLOW-UP (06MAY2020): THIS FOLLOW-UP IS THE FULL PUBLICATION FROM THE JOURNAL OF EUR RADIOL; 2000; 10(5); 802-5, ENTITLED; EMBOLIZATION FOR GASTROINTESTINAL HEMORRHAGES. INTRODUCTION: THE PRESENT RETROSPECTIVE STUDY EVALUATED THE EXPERIENCES OF OUR DEPARTMENT WITH INTERVENTIONAL TREATMENT FOR GI HEMORRHAGE OVER AN 8-YEAR PERIOD FROM 1989 TO 1997. PATIENTS AND METHODS: SINCE 1989 A TOTAL OF 35 PATIENTS WITH GI HEMORRHAGE HAVE BEEN REFERRED TO OUR DEPARTMENT FOR RADIOLOGICAL INTERVENTION. PATIENTS WERE EITHER REFERRED FOR PRIMARY TREATMENT OR FOLLOWING UNSUCCESSFUL ENDOSCOPIC OR SURGICAL THERAPY. THE PATIENTS (25 MEN AND 10 WOMEN; AVERAGE AGE 57 YEARS, AGE RANGE 18-89 YEARS) SUFFERED FROM ULCERS OF THE DISTAL ESOPHAGUS, STOMACH, OR DUODENUM (N =7),EROSION OF THE INTESTINAL WALL SECONDARY TO MALIGNANCIES IN THE UPPER (N = 3) OR LOWER GITRACT (N = 3),COLONIC DIVERTICULA (N = 3), VASCULAR MALFORMATIONS OF THE INTESTINE (N = 4), OR HEMORRHOIDS (N = 2). POSTOPERATIVE HEMORRHAGE WAS OBSERVED IN SIX CASES (UPPER GI TRACT: N = 4; LOWER GI TRACT: N = 2), POST INFLAMMATORY BLEEDING IN FOUR (POST PANCREATITIS, N = 2 EACH FOR UPPER AND LOWER GI BLEEDING), AND POSTTRAUMATIC LESIONS IN TWO OTHER PATIENTS N=1 EACH FOR UPPER AN LOWER GI HEMORRHAGE). IN ONE CASE THE CAUSE OF THE BLEEDING DISTAL TO THE LIGAMENT OF TREITZ COULD NOT BE DETERMINED. PATIENTS FIRST UNDERWENT ROUTINE DIAGNOSTIC ANGIOGRAPHY (POLYTRON 40, SIEMENS, ERLANGEN, GERMANY) WITH STANDARD 5-F TRANSFEMORAL ACCESS (TERUMO, FRANKFURT, GERMANY). IF THE SOURCE OF BLEEDING COULD NOT BE DETERMINED AT FIRST ANGIOGRAPHY, THE PROCEDURE WAS REPEATED IN THE CASE OF FURTHER DECREASE IN PATIENTS' HEMOGLOBIN AND HEMATOCRIT LEVELS. ONCE THE SOURCE OF BLEEDING WAS DETERMINED, SELECTIVE CATHETERIZATION (5-F COBRA OR SIDEWINDER CATHETER, MALLINCKRODT, HENNEF/SIEG, GERMANY) WITH SUBSEQUENT SUPER SELECTIVE CATHETERIZATION WITH A COAXIAL 2.7-F MICROCATHETER (TARGET, RATINGEN, GERMANY) WAS PERFORMED. EMBOLIZATION WAS PERFORMED AS DISTALLY AS POSSIBLE USING SOLID AND LIQUID MATERIALS AND VARIOUS COMBINATIONS. MOST FREQUENTLY, EMBOLIZATION WAS PERFORMED USING METAL COILS (N = 14; TARGET, RATINGEN, GERMANY) AND ETHIBLOC (N = 12; ETHICON, NORDERSTEDT, GERMANY). IN ADDITION, COMBINATION TREATMENTS USING GELFOAM (SPONGOSTAN STANDARD, FERROSAN, DENMARK) AND TISSUE ADHESIVE (N = 2; TISSUCOL DUO S, IMMUNO, HEIDELBERG, GERMANY); ETHIBLOC AND TISSUE ADHESIVE (N = 1); METAL COILS AND ETHIBLOC (N = 2); AND GELFOAM WITH COILS (N = 1). IN ONE CASE EACH, HEMORRHAGE WAS CHECKED USING POLYVINYL ALCOHOL PARTICLES (PVA, TRIGON ,MONCHENGLADBACH, GERMANY), PLANNED WIRE DISSECTION OF THE ARTERIAL WALL, AND PLACEMENT OF A COVERED STENT (TALENT, MUNICH, GERMANY). DOSAGE OF THE VARIOUS EMBOLISATES IN INDIVIDUAL TREATMENT SESSIONS RANGED UP TO A MAXIMUM 11 METAL COILS AND FROM 0.5 TO 3.0 ML OF ETHIBLOC. COMBINATION TREATMENTS USED SMALLER DOSES OF THE INDIVIDUAL COMPONENTS WITH UP TO TWO GELFOAM PARTICLES AND 0.5-1.0 ML OF TISSUE ADHESIVE. THE VASCULAR REGIONS TREATED RANGED FROM THE RIGHT GASTRIC ARTERY TO THE SUPERIOR RECTAL ARTERY. EMBOLIZATION'S WERE PERFORMED MOST FREQUENTLY IN THE REGION OF THE GASTRODUODENAL, SUPERIOR MESENTERIC AND INFERIOR MESENTERIC ARTERIES. EMBOLIZATION WITH METAL COILS WAS PERFORMED AFTER THE COILS WERE INTRODUCED INTO THE COAXIAL CATHETER USING AN INSERTION KIT. COILS WERE RELEASED BY MEANS OF PUSHER WIRE. LIQUID ETHIBLOC WAS WARMED TO BODY TEMPERATURE AND MIXED VIA A THREE-WAY TAP WITH LIPIODOL IN A PROPORTION OF 2:1. INJECTION WAS PERFORMED SUPER SELECTIVELY VIA MICROCATHETER UNDER FLUOROSCOPIC MONITORING WITH1-MLSYRINGES.GELFOAM PARTICLE SWERE SHAPED MANUALLY, INTRODUCED INTO THE CATHETER AND THEN RELEASED UNDER THE STREAM OF A 3-ML MIXTURE OF NORMAL SALINE AND CONTRAST MEDIUM (1:1). TISSUE ADHESIVE AND PVA PARTICLES WERE APPLIED DIRECTLY THROUGH THE COAXIAL SYSTEM. AFTER TREATMENT, THE MICROCATHETER WAS REMOVED AND CONTROL ANGIOGRAPHY PERFORMED VIA THE INDWELLING MOTHER CATHETER. THE REQUIRED VOLUME OF CONTRAST MEDIUM (SOLUTRAST 300, BYK-GULDEN, KONSTANZ, GERMANY) RANGED BETWEEN 150 AND 350 ML. INFORMED CONSENT WAS OBTAINED FROM EVERY PATIENT PRIOR TO THE PROCEDURE. RESULTS A TOTAL OF 43 EMBOLIZATION PROCEDURES WERE PERFORMED IN THE 35 PATIENTS INCLUDED IN THIS STUDY (TWO TREATMENTS IN 6 PATIENTS, THREE TREATMENTS IN1 PATIENT). HEMORRHAGE WAS STOPPED COMPLETELY IN 29 CASES (83%). SUCCESS IN UPPER GI BLEEDING WAS ACHIEVED IN 15 OF 17 PATIENTS (88%) AND IN 14 OF 19 CASES WITH LOWER GI HEMORRHAGES (78%). IN 27 PATIENTS (77%) THIS WAS ACHIEVED AT FIRST INTERVENTION, WHEREAS 2 PATIENTS (6%) WITH THE SITE DISTAL TO THE LIGAMENT OF TREITZ REQUIRED A SECOND TREATMENT. IN 5 PATIENTS HEMORRHAGE WAS EITHER REDUCED IN SEVERITY BUT PERSISTED OR RECURRED (UPPER GI TRACT: N = 2; LOWER GI TRACT: N = 3). COMPLETE HEMOSTASIS WAS NOT ACHIEVED IN A SECOND OR THIRD TREATMENT SESSION. IN 1 PATIENT (3%), DESPITE REPEATED ANGIOGRAPHY, THE SOURCE OF BLEEDING COULD NOT BE DETERMINED; THUS, NO EMBOLIZATION PROCEDURE WAS POSSIBLE. IN ANOTHER 62-YEAR-OLD MALE, A SECOND ANGIOGRAPHY FAILED TO SHOW CONTRAST MEDIUM ESCAPE. THE PRESENCE OF AVASCULAR MALFORMATION, ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY, WAS, HOWEVER, ASSUMED TO BE THE SOURCE OF BLEEDING. WE DID NOT PERFORM A PROVOCATION TEST USING FIBRINOLYSIS, AS HAS BEEN DESCRIBED ELSEWHERE, AND ELIMINATED THE DEFECT WITH A COMBINATION OF COILS AND ETHIBLOC. AN ATYPICALLY FORMED BRANCH LEADING TO THE SPLEEN DRAINED THE FLUID EMBOLISATE, WHICH RESULTED IN A PARTIAL INFARCTION OF THE SPLEEN. AFTER 2 DAYS OF SUB FEBRILE TEMPERATURES, THIS WAS VERIFIED AT CT. AFTER 8 DAYS, THE PATIENT'S TEMPERATURE NORMALIZED AND NO OTHER ADVERSE CONSEQUENCES WERE OBSERVED. IN THE YEARS 1990-1992, 4 PATIENTS EXPERIENCED INTESTINAL ISCHEMIAS WITH FATAL OUTCOMES IN EACH CASE. OTHER THAN THESE INCIDENTS, THERE WERE NO SERIOUS OR LIFE-THREATENING COMPLICATIONS. THE RATE OF COMPLICATIONS WAS 14%. ALL COMPLICATIONS WERE ASSOCIATED WITH THE USE OF ETHIBLOC, EITHER ALONE OR IN COMBINATION WITH OTHER AGENTS. DISCUSSION THE GRAVEST COMPLICATION ASSOCIATED WITH EMBOLIZATION REMAINS INTESTINAL ISCHEMIA. THREATS OF SUCH ISCHEMIA'S ARE REPORTED IN THE LITERATURE UP TO 20%. OUR OWN COLLECTIVE IS COMPARABLE WITH AN ISCHEMIA RATE OF 14%. BOWEL NECROSIS OCCURRED, AS HAS BEEN REPORTED ELSEWHERE, IN 4 OF 18 CASES (22%) WITH LOWER GI BLEEDING. DESPITE THIS HIGH RATE, THERE APPEARS TO BE A STEADY DECLINE IN THE RATE OF COMPLICATIONS ASSOCIATED WITH EMBOLIZATION. IN CONJUNCTION WITH INCREASING EXPERIENCE WITH THE METHOD, THE CHOICE OF EMBOLI SATE SEEMS TO BE OF DECISIVE IMPORTANCE. ALL INSTANCES OF BOWEL NECROSIS OCCURRED IN ASSOCIATION WITH THE USE OF ETHIBLOC. SIMILARLY, THE CASE OF INFARCTION OF THE SPLEEN OCCURRED FOLLOWING APPLICATION OF A COMBINATION OF METAL COILS AND ETHIBLOC. IN THE PAST 3 YEARS THE SPLENIC INFARCTION WAS THE ONLY SERIOUS COMPLICATION, ONE WHICH, FORTUNATELY, WAS WITHOUT FURTHER CONSEQUENCES FOR THE PATIENT. IN ADDITION TO TEMPORARY EMBOLISATES, SUCH AS GELFOAM PARTICLES, THE USE OF COILS WAS LESS FREQUENTLY ASSOCIATED WITH ISCHEMIC COMPLICATIONS THAN FLUID EMBOLISATES. RECENT STUDIES HAVE REPORTED THE INCIDENCE OF ISCHEMIC COMPLICATIONS FOR INTERVENTION IN THE COLON TO BE APPROXIMATELY 20%. THESE EVENTS, HOWEVER, GENERALLY REQUIRE NO FURTHER INTERVENTION AND THE ASSOCIATED 30-DAY MORTALITY IS 7%, WHICH IS LOWER THAN IN OUR COLLECTIVE. NEW TECHNIQUES WITH METAL COILS ATTACHED TO WIRE SALSOMINIMIZE THE DANGER OF ESCAPE OF THE EMBOLISATE. FLUID EMBOLISATES, HOWEVER, CANNOT, IN COMPARISON WITH COILS, BE SEEN AS AGENTS OF CHOICE. USING SUITABLE EMBOLIZATION MATERIALS, PERCUTANEOUS CATHETER TREATMENT REPRESENTS A LIFE-SAVING ALTERNATIVE TO SURGICAL TREATMENT IN CASES OF GI HEMORRHAGE NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED." }, { "mdr_text_key": "196757494", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY) CASE SERIES USING GELATIN SPONGE [OFF LABEL USE], LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY) CASE SERIES USING GELATIN SPONGE [PRODUCT USE IN UNAPPROVED INDICATION], REBLEEDING [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], ISCHEMIC BOWEL [GASTROINTESTINAL ISCHAEMIA], SPLENIC INFARCTION [SPLENIC INFARCTION] NARRATIVE: THIS IS A LITERATURE-SPONTANEOUS REPORT FROM JOURNAL OF EUR RADIOL; 2000; 10(5); 802-5. ENTITLED; EMBOLIZATION FOR GASTROINTESTINAL HEMORRHAGES. A CONTACTABLE OTHER HCP REPORTED FOR A PATIENT THAT: A PATIENT OF UNSPECIFIED AGE AND GENDER STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY). THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS REPORTED LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY) CASE SERIES USING GELATIN SPONGE SUSPENSION REPORT ADVERSE EVENTS OF REBLEEDING, ISCHEMIC BOWEL, AND PARTIAL SPLENIC INFARCTION, ALTHOUGH THESE DO NOT DISTINGUISH BETWEEN PATIENTS WHO RECEIVED GELFOAM AND OTHER HEMOSTATIC AGENTS OR COILS. THE PATIENT EXPERIENCED REBLEEDING, ISCHEMIC BOWEL, SPLENIC INFARCTION, ALL ON AN UNSPECIFIED DATE WITH OUTCOME OF UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENTS FOR ABSORBABLE GELATIN WAS UNKNOWN. COMPANY CLINICAL EVALUATION COMMENT: USING GELATIN SPONGE SUSPENSION DURING LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY) AS HEMOSTATIC AGENT IS CONSIDERED AS OFF LABEL USE FOR ABSORBABLE GELATIN (GELFOAM). AN ASSOCIATION BETWEEN THE REPORTED EVENTS REBLEEDING, ISCHEMIC BOWEL, AND PARTIAL SPLENIC INFARCTION, AND THE OFF LABEL USE OF GELFOAM CAN NOT BE EXCLUDED, ALTHOUGH THESE DO NOT DISTINGUISH BETWEEN PATIENTS WHO RECEIVED GELFOAM AND OTHER HEMOSTATIC AGENTS OR COILS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. COMMENT: USING GELATIN SPONGE SUSPENSION DURING LARGER VIR (VASCULAR INTERVENTIONAL RADIOLOGY) AS HEMOSTATIC AGENT IS CONSIDERED AS OFF LABEL USE FOR ABSORBABLE GELATIN (GELFOAM). AN ASSOCIATION BETWEEN THE REPORTED EVENTS REBLEEDING, ISCHEMIC BOWEL, AND PARTIAL SPLENIC INFARCTION, AND THE OFF LABEL USE OF GELFOAM CAN NOT BE EXCLUDED, ALTHOUGH THESE DO NOT DISTINGUISH BETWEEN PATIENTS WHO RECEIVED GELFOAM AND OTHER HEMOSTATIC AGENTS OR COILS. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/19/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04452", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200521", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200521", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200521", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230320", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200521", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10079172", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200506", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "311605301", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERAPY DATE ESTIMATED. THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "191707354", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF DEATH IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL PATIENT EFFECTS WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. \u00bfARTICLE TITLE-PROSPECTIVE, RANDOMIZED TRIAL OF BIORESORBABLE SCAFFOLDS VS. EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY STENTING FOR MYOCARDIAL INFARCTION: THE INTRACORONARY SCAFFOLD ASSESSMENT A RANDOMIZED EVALUATION OF ABSORB IN MYOCARDIAL INFARCTION (ISAR-ABSORB MI) TRIAL\u00bf. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. (B)(4)." }, { "mdr_text_key": "191707355", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK ABSORB THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, REVASCULARIZATION, THROMBOSIS, AND DEATH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: PROSPECTIVE, RANDOMIZED TRIAL OF BIORESORBABLE SCAFFOLDS VS. EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY STENTING FOR MYOCARDIAL INFARCTION: THE INTRACORONARY SCAFFOLD ASSESSMENT A RANDOMIZED EVALUATION OF ABSORB IN MYOCARDIAL INFARCTION (ISAR-ABSORB MI) TRIAL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04454", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200521", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200521", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200521", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230821", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200521", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10079197", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200506", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318854260", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "191732754", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE PATIENT DEATHS REFERENCED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. \u00bfARTICLE TITLE-PROSPECTIVE, RANDOMIZED TRIAL OF BIORESORBABLE SCAFFOLDS VS. EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY STENTING FOR MYOCARDIAL INFARCTION: THE INTRACORONARY SCAFFOLD ASSESSMENT A RANDOMIZED EVALUATION OF ABSORB IN MYOCARDIAL INFARCTION (ISAR-ABSORB MI) TRIAL\u00bf. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "191732755", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK ABSORB THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFRACTION, REVASCULARIZATION, THROMBOSIS, AND DEATH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: PROSPECTIVE, RANDOMIZED TRIAL OF BIORESORBABLE SCAFFOLDS VS. EVEROLIMUS-ELUTING STENTS IN PATIENTS UNDERGOING CORONARY STENTING FOR MYOCARDIAL INFARCTION: THE INTRACORONARY SCAFFOLD ASSESSMENT A RANDOMIZED EVALUATION OF ABSORB IN MYOCARDIAL INFARCTION (ISAR-ABSORB MI) TRIAL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04491", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200526", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200526", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200526", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "UNK", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230623", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200526", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10087792", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200505", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315219991", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4)." }, { "mdr_text_key": "192022980", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF DEATH/EVENT AND IMPLANT ARE ESTIMATED TO BE (B)(6) 2015. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF DEATH IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE." }, { "mdr_text_key": "192022981", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED, PREDICTORS OF LONG-TERM ADVERSE EVENTS AFTER ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: A 1,933-PATIENT POOLED ANALYSIS FROM INTERNATIONAL REGISTRIES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04492", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200526", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200526", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200526", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "UNK", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200526", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10087921", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200505", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318861402", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "C4: THERAPY DATE ESTIMATED. THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [ARTICLE CN-032113.PDF]." }, { "mdr_text_key": "192156914", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT AND IMPLANT IS ESTIMATED TO BE (B)(6) 2015. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE PATIENT DEATHS REFERENCED ARE BEING FILED ON A SEPARATE MEDWATCH REPORT #. LITERATURE. \u00bfARTICLE TITLE- PREDICTORS OF LONG-TERM ADVERSE EVENTS AFTER ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: A 1,933-PATIENT POOLED ANALYSIS FROM INTERNATIONAL REGISTRIES\"." }, { "mdr_text_key": "192156915", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED, PREDICTORS OF LONG-TERM ADVERSE EVENTS AFTER ABSORB BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: A 1,933-PATIENT POOLED ANALYSIS FROM INTERNATIONAL REGISTRIES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-04536", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200527", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170718", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200527", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200527", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/02/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230515", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200527", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10094093", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "311601158", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "315221463", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO 63 YEARS OF AGE. A3: THE MAJORITY OF PATIENTS WERE MALE. D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD SYSTEM, ABSORB, INSTRUCTIONS FOR USE, AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE." }, { "mdr_text_key": "192265804", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO 63 YEARS OF AGE. THE MAJORITY OF PATIENTS WERE MALE. DATES OF DEATH, EVENT, AND IMPLANT: ESTIMATED. THE DEVICE WAS IMPLANTED AND WILL NOT RETURN FOR ANALYSIS. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL PATIENT EFFECTS AND THE XIENCE STENT REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "192265805", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD AND XIENCE STENT MAY BE RELATED TO TARGET VESSEL MYOCARDIAL INFARCTION, DEVICE THROMBOSIS, CARDIAC DEATH, DEATH, ISCHEMIA-DRIVEN TARGET LESION REVASCULARIZATION, AND RESTENOSIS SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY.\u00bf" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/10/2020;07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04537", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200527", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170718", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200527", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200527", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/02/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200527", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10094094", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318685046", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "193065401", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO (B)(6) OF AGE. THE MAJORITY OF PATIENTS WERE MALE. THE DEVICE WAS IMPLANTED AND WILL NOT RETURN FOR ANALYSIS. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. LITERATURE ATTACHMENT: \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY.\" THE ADDITIONAL PATIENT EFFECTS AND THE XIENCE STENT REFERENCED, ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "193065402", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD AND XIENCE STENT MAY BE RELATED TO TARGET VESSEL MYOCARDIAL INFARCTION (MI), MI, DEVICE THROMBOSIS, CARDIAC DEATH, DEATH, ISCHEMIA-DRIVEN TARGET LESION REVASCULARIZATION, AND RESTENOSIS SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \"2-YEAR OUTCOMES WITH THE ABSORB BIORESORBABLE SCAFFOLD FOR TREATMENT OF CORONARY ARTERY DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF SEVEN RANDOMISED TRIALS WITH AN INDIVIDUAL PATIENT DATA SUBSTUDY.\u00bf" }, { "mdr_text_key": "316323309", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: THE MAJORITY OF PATIENTS WERE OVER OR EQUAL TO 63 YEARS OF AGE A3: THE MAJORITY OF PATIENTS WERE MALE B3, D6: ESTIMATED D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF THROMBOSIS, MYOCARDIAL INFARCTION, ISCHEMIA AND RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD SYSTEM, ABSORB, INSTRUCTIONS FOR USE, AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/10/2020;07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04582", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200528", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180824", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200528", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200528", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20130917", "model_number": "", "catalog_number": "1012464-18", "lot_number": "3032261", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/12/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200528", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "83", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stenosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10098722", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200507", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193305071", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT ESTIMATED. LITERATURE ATTACHMENT: CHRONIC TOTAL OCCLUSION 5 YEARS AFTER BIORESORBABLE VASCULAR SCAFFOLD IMPLANTATION: A SERIAL OPTICAL COHERENCE TOMOGRAPHY ASSESSMENT. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "193305072", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A LITERATURE ARTICLE THAT A PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION WITH THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD. ON 8/24/2013 THE ABSORB SCAFFOLD WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. AT THE 12 AND 24 MONTH FOLLOW-UP VISITS, CORONARY ANGIOGRAM AND OPTICAL COHERENCE TOMOGRAPHY WERE PERFORMED. THESE TESTS SHOWED PRESERVED VESSEL PATENCY WITH SIGNS OF PERISTRUT LOW-INTENSITY AREAS WITHIN THE NEOINTIMA AND FEATURES OF ATHEROSCLEROSIS PROGRESSION AT THE DISTAL EDGE OF THE SCAFFOLD. THERE WERE NO SIGNS OF RESTENOSIS AT 12 AND 24 MONTHS. A SCHEDULED FOLLOW-UP ANGIOGRAPHY AT 60 MONTHS REVEALED A TOTAL OCCLUSION AT THE DISTAL PART OF THE SCAFFOLD. THE PATIENT DID NOT HAVE ANY SYMPTOMS. WITHIN THE PROXIMAL EDGE, OPTICAL COHERENCE TOMOGRAPHY SHOWED A COMPLETE ABSORPTION OF STENT STRUTS WITH NEOINTIMAL PROLIFERATION AND A DECREASED SCAFFOLD AREA AND DIAMETER WAS OBSERVED. ALTHOUGH THE EXACT REASON FOR THE OCCLUSION IS UNKNOWN, THE LOCATION OF THE OCCLUSION POINTS TO THE STENT EDGE RESTENOSIS AS THE REASON FOR OCCLUSION. THE OCCLUSION WAS TREATED WITH FOUR EVEROLIMUS ELUTING STENTS. THERE WAS GOOD STENT EXPANSION AND APPOSITION. NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "318842963", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318653162", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.B1: THERE WAS NO PRODUCT PROBLEM FOR THIS PATIENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/06/2020;07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3010252479-2020-00069", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200610", "manufacturer_address_2": "", "pma_pmn_number": "P180025", "date_of_event": "20200518", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200610", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200610", "brand_name": "MANTA 18F", "generic_name": "VASCULAR CLOSURE DEVICE", "manufacturer_d_name": "ESSENTIAL MEDICAL, INC.", "manufacturer_d_address_1": "260 SIERRA DRIVE", "manufacturer_d_address_2": "SUITE 120", "manufacturer_d_city": "EXTON, PA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210715", "model_number": "2115", "catalog_number": "2115", "lot_number": "MN2001261", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MGB", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00856279007062", "udi_public": "00856279007062", "openfda": { "device_name": "Device, Hemostasis, Vascular", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Malposition of Device" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/20/2020", "manufacturer_contact_country": "", "date_changed": "20230825", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200610", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "87 YR", "patient_sex": "", "patient_weight": "63", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Extravasation" ] } ], "distributor_city": "", "date_report": "20200518", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10137360", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200520", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321975442", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. NO RETURN PRODUCT EVALUATION COULD BE COMPLETED. THE DEVICE LOT HISTORY RECORD REVIEWED INDICATED NO NON-CONFORMITIES RELATED TO THIS LOT THEREFORE SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION SUBMITTED, THE MANTA DEPLOYMENT STEPS WERE FOLLOWED APPROPRIATELY. HOWEVER, DURING THE FINAL STEPS OF DEPLOYMENT, THE SKIN TENTED WHILE WITHDRAWING THE DEVICE. THE SKIN TENTING WAS DUE TO THE ACCESS SITE NOT HAVING NEUTRAL DIGITAL PRESSURE APPLIED WHILE WITHDRAWING THE MANTA; ALTERING THE PUNCTURE LOCATION AND DEPLOYMENT DEPTH FROM THE INITIAL MEASUREMENT OF 2.5CM +1 CM AND RESULTING IN A SHALLOW TRACT DEPLOYMENT OF THE DEVICE. A SURGICAL CUT DOWN VISUALLY CONFIRMED THE COLLAGEN, TOGGLE, AND LOCK INTACT IN THE TISSUE TRACT." }, { "mdr_text_key": "195920974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN INVESTIGATION HAS BEEN OPENED TO REVIEW DEVICE HISTORY RECORD, RISK DOCUMENTATION, AND CASE IMAGING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY DURING A PROCEDURE WHERE A MANTA WAS USED FOR CLOSURE OF FEMORAL ACCESS. THE PATIENT REQUIRED SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE MANTA INSTRUCTIONS FOR USE ALSO PROVIDES PRECAUTIONS THAT INCLUDE: IN THE EVENT THAT BLEEDING FROM THE FEMORAL ACCESS SITE PERSISTS AFTER THE USE OF THE MANTA DEVICE, THE PHYSICIAN SHOULD ASSESS THE SITUATION. BASED ON THE PHYSICIAN ASSESSMENT OF THE AMOUNT OF BLEEDING, USE MANUAL OR MECHANICAL COMPRESSION, APPLICATION OF BALLOON PRESSURE FROM A SECONDARY ACCESS SITE, PLACEMENT OF A COVERED STENT, AND/OR SURGICAL REPAIR TO OBTAIN HEMOSTASIS. THE MANTA INSTRUCTIONS FOR USE LISTS POTENTIAL ADVERSE EVENTS RELATED TO THE DEPLOYMENT OF VASCULAR CLOSURE DEVICES INCLUDING ACCESS SITE COMPLICATIONS LEADING TO BLEEDING, HEMATOMA, PSEUDOANEURYSM, OR ARTERIO-VENOUS FISTULA, POSSIBLY REQUIRING BLOOD TRANSFUSION, SURGICAL REPAIR, AND/OR ENDOVASCULAR INTERVENTION. THE MANTA INSTRUCTIONS FOR USE LISTS PROCEDURE REQUIREMENTS THAT INCLUDE: IF THE MANTA CLOSURE DOES NOT DEPLOY PROPERLY IN THE ARTERY AND HEMOSTASIS IS NOT ACHIEVED, THE CLOSURE AND ALL ABSORBABLE COMPONENTS MAY BE REMOVED FROM THE PATIENT IF MEDICALLY NECESSARY." }, { "mdr_text_key": "195920975", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PATIENT HAD A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) ON (B)(6) 2020. THE PATIENT'S FEMORAL ARTERY MEASURED 9.0 MM IN DIAMETER AND WAS REPORTED TO HAVE MINOR CALCIFICATION PRESENT. THE HEART VALVE WAS DELIVERED USING A 16F SHEATH. THE REPORTER CONFIRMED THE OPERATOR HAD NO DIFFICULTIES ADVANCING OR WITHDRAWING PROCEDURE SHEATHS. THE MANTA 18F VASCULAR CLOSURE DEVICE (MANTA) DEPLOYMENT DEPTH WAS MEASURED AT 2.5 CM. + 1.0 CM. PROTAMINE WAS ADMINISTERED TO THE PATIENT 60-120 SECOND PRIOR TO THE DEPLOYMENT OF THE MANTA. THE REPORTER STATED PROPER STEPS WERE TAKEN FOR ACCESS, MEASUREMENT OF MANTA DEPLOYMENT DEPTH, TENSION DURING MANTA DEPLOYMENT AND EXECUTION OF THE LOCK COMPACTION. IT WAS REPORTED THAT WHEN THE MANTA WAS PULLED BACK TO DEPLOYMENT DEPTH, THE SKIN MAY HAVE \"TENTED\", ALTERING THE DEPLOYMENT DEPTH FROM WHAT WAS MEASURED. THE REPORTER STATED THAT THE DEPLOYMENT WAS MADE TOO SHALLOW RESULTING IN THE ENTIRE MANTA DEVICE BEING DEPLOYED PERFECTLY IN THE TISSUE TRACT. HEMOSTASIS WAS NOT ACHIEVED WITH MANTA. A BALLOON NOR COVERED STENT WAS ABLE TO BE ADVANCED TO THE CLOSURE SITE FROM THE CONTRALATERAL SIDE DUE TO TORTUOSITY OF THE ILIAC VESSELS. A SURGICAL CUT DOWN WAS DONE WHERE THE COLLAGEN, TOGGLE AND LOCK WERE LOCATED INTACT IN THE TISSUE TRACT. THE ENTIRE MANTA DEVICE WAS EXPLANTED FROM THE TISSUE TRACT. HEMOSTASIS WAS ACHIEVED THROUGH SURGICAL REPAIR." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "03/31/2021" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04919", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20161203", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "ABSORB BRS", " ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "68 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10143699", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318863850", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "194813797", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF THROMBOSIS IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. ARTICLE TITLED, VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "194813798", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT HAD TWO 2.5 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IMPLANTED IN THE RIGHT CORONARY ARTERY FOR A LENGTH OF 36 MM. ANGIOGRAPHIC FOLLOW UP CONFIRMED FAVORABLE RESULTS. 702 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH VERY LATE SCAFFOLD THROMBOSIS AND OCCLUSION IN THE DISTAL SCAFFOLD. THE AREA WAS TREATED WITH BALLOON DILATATION AND STENT IMPLANTATION. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04928", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160529", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230713", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "3.0X28 MM ABSORB", " 3.0X28 MM ABSORB" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10144852", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318964445", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "194864717", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "194864718", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND A 3.0X28 MM ABSORB BIORESORBABLE SCAFFOLD (BRS) WAS IMPLANTED IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. A STENOSIS OF THE MEDIAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WAS ALSO TREATED WITH A 3.0X28 MM ABOSORB BRS. SIX MONTH FOLLOW UP SHOWED A FAVORABLE RESULT IN BOTH AREAS. 514 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI AND THROMBOTIC OCCLUSION OF THE BRS IN THE LCX. FLOW WAS RESTORED AFTER BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT (DES). THE LAD LESION ALSO SHOWED DIFFUSE IN STENT RESTENOSIS WHICH WAS TREATED WITH A DES. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04929", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160529", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "3.0X28 MM ABSORB" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stenosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145096", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195369595", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT AND IMPLANT DATES ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF STENOSIS IS LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ATTACHMENT: ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195369596", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND A 3.0X28 MM ABSORB BIORESORBABLE SCAFFOLD (BRS) WAS IMPLANTED IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. A STENOSIS OF THE MEDIAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WAS ALSO TREATED WITH A 3.0X28 MM ABSORB BRS. SIX MONTH FOLLOW UP SHOWED A FAVORABLE RESULT IN BOTH AREAS. 514 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI AND THROMBOTIC OCCLUSION OF THE BRS IN THE LCX. FLOW WAS RESTORED AFTER BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT (DES). THE LAD LESION ALSO SHOWED DIFFUSE IN STENT RESTENOSIS WHICH WAS TREATED WITH A DES. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." }, { "mdr_text_key": "318665123", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04935", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20150101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2020", "manufacturer_contact_country": "", "date_changed": "20230717", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "2 ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145677", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319106260", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF DISSECTION, THROMBOSIS, STENOSIS, AND MYOCARDIAL INFARCTION ARE AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"NA" }, { "mdr_text_key": "195099257", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE 2 ADDITIONAL ABSORB DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHYNA." }, { "mdr_text_key": "195099258", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND SUBTOTAL OCCLUSION OF THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED WITH THREE ABSORB BIORESORBABLE SCAFFOLDS (BRS). TWO 3.5X28 MM AND ONE 3.5X15 MM WERE IMPLANTED. POST IMPLANT, A DISTAL EDGE DISSECTION WAS NOTED ON THE DISTAL BRS, AND A DRUG ELUTING STENT WAS IMPLANTED TO COVER THE DISSECTION. ANGIOGRAPHY POST IMPLANTATION SHOWED MILD RESTENOSIS IN THE MID RCA, WITH NO INDICATION FOR TREATMENT. 532 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED RECURRENT MYOCARDIAL INFARCTION WITH VERY LATE SCAFFOLD THROMBOSIS (VLSCT) AND SUBTOTAL THROMBOTIC OCCLUSION WITHIN THE SCAFFOLDED SEGMENT OF THE MID RCA. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SCAFFOLD DISCONTINUITY IN THE DISTAL BRS WITH OVERLYING THROMBUS. IN ADDITION, THERE WAS RESTENOSIS WITH AN OCT-DERIVED PERCENT LUMEN AREA STENOSIS OF 54%. THE LESION WAS TREATED WITH BALLOON DILATION FOLLOWED BY IMPLANTATION OF A DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/03/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04940", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230710", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "2 ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145807", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195369832", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE 2 ADDITIONAL ABSORB DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ATTACHMENT: ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195369833", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND SUBTOTAL OCCLUSION OF THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED WITH THREE ABSORB BIORESORBABLE SCAFFOLDS (BRS). TWO 3.5X28 MM AND ONE 3.5X15 MM WERE IMPLANTED. POST IMPLANT, A DISTAL EDGE DISSECTION WAS NOTED ON THE DISTAL BRS, AND A DRUG ELUTING STENT WAS IMPLANTED TO COVER THE DISSECTION. ANGIOGRAPHY POST IMPLANTATION SHOWED MILD RESTENOSIS IN THE MID RCA, WITH NO INDICATION FOR TREATMENT. 532 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED RECURRENT MYOCARDIAL INFARCTION WITH VERY LATE SCAFFOLD THROMBOSIS (VLSCT) AND SUBTOTAL THROMBOTIC OCCLUSION WITHIN THE SCAFFOLDED SEGMENT OF THE MID RCA. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SCAFFOLD DISCONTINUITY IN THE DISTAL BRS WITH OVERLYING THROMBUS. IN ADDITION, THERE WAS RESTENOSIS WITH AN OCT-DERIVED PERCENT LUMEN AREA STENOSIS OF 54%. THE LESION WAS TREATED WITH BALLOON DILATION FOLLOWED BY IMPLANTATION OF A DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" }, { "mdr_text_key": "315543965", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318652708", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS, STENOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/06/2020;08/03/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04942", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160616", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "2 ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10145936", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195368222", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE 2 ADDITIONAL ABSORB DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. ATTACHMENT: ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195368223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STEMI AND SUBTOTAL OCCLUSION OF THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS TREATED WITH THREE ABSORB BIORESORBABLE SCAFFOLDS (BRS). TWO 3.5X28 MM AND ONE 3.5X15 MM WERE IMPLANTED. POST IMPLANT, A DISTAL EDGE DISSECTION WAS NOTED ON THE DISTAL BRS, AND A DRUG ELUTING STENT WAS IMPLANTED TO COVER THE DISSECTION. ANGIOGRAPHY POST IMPLANTATION SHOWED MILD RESTENOSIS IN THE MID RCA, WITH NO INDICATION FOR TREATMENT. 532 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED RECURRENT MYOCARDIAL INFARCTION WITH VERY LATE SCAFFOLD THROMBOSIS (VLSCT) AND SUBTOTAL THROMBOTIC OCCLUSION WITHIN THE SCAFFOLDED SEGMENT OF THE MID RCA. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SCAFFOLD DISCONTINUITY IN THE DISTAL BRS WITH OVERLYING THROMBUS. IN ADDITION, THERE WAS RESTENOSIS WITH AN OCT-DERIVED PERCENT LUMEN AREA STENOSIS OF 54%. THE LESION WAS TREATED WITH BALLOON DILATION FOLLOWED BY IMPLANTATION OF A DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" }, { "mdr_text_key": "318840827", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318652949", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS, STENOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/06/2020;08/03/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04954", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "53 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200804", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146412", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195368476", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ATTACHMENT: ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195368477", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT HAD INTERVENTION OF THE RIGHT CORONARY ARTERY (RCA) WITH A 3.0X18 MM ABSORB BIORESORBABLE SCAFFOLD (BRS). FOLLOW UP 6 MONTHS LATER SHOWED A GOOD RESULT. 393 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND VERY LATE SCAFFOLD THROMBOSIS (VLSCT). INTRAPROCEDURAL OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED SCAFFOLD DISCONTINUITY WITH MALPOSED STRUTS IN THE VESSEL LUMEN AND OVERLYING THROMBUS. FLOW WAS RESTORED WITH THROMBUS ASPIRATION AND BALLOON DILATATION. 46 DAYS LATER, THE PATIENT SUFFERED RECURRENT VLSCT. OCT WAS PERFORMED AND SHOWED MORE MARKED SCAFFOLD DISCONTINUITY WITH OVERLYING THROMBUS. THE PATIENT WAS TREATED WITH A DRUG ELUTING STENT (DES) WITH GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." }, { "mdr_text_key": "318840796", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHMENT ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/04/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04955", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170609", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2020", "manufacturer_contact_country": "", "date_changed": "20230817", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200804", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146495", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319014124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION, STENOSIS AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHMENT ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." }, { "mdr_text_key": "194963808", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHYNA." }, { "mdr_text_key": "194963809", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NSTEMI AND WAS TREATED WITH A 3.5X18 MM ABSORB BIORESORBABLE SCAFFOLD (BRS). 890 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED STEMI AND ANGIOGRAPHY SHOWED VERY LATE SCAFFOLD THROMBOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED AND SHOWED A FOCAL AREA OF MILD TO MODERATE RESTENOSIS, A TISSUE BRIDGE POSSIBLY CONSEQUENT ON MALPOSITION AND FOCAL SCAFFOLD DISCONTINUITY WITH THROMBOSIS. BALLOON DILATATION AND DRUG ELUTING STENT IMPLANTATION WAS PERFORMED WITH GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/04/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04957", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "71 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146595", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318766270", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." }, { "mdr_text_key": "318652874", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "194957544", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHYNA." }, { "mdr_text_key": "194957545", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT HAD A 3.5X12 MM ABSORB BIORESORBABLE SCAFFOLD IMPLANTED IN THE RIGHT CORONARY ARTERY. FOLLOW UP ANGIOGRAPHY SHOWED GOOD RESULT WITHOUT SIGNIFICANT RESTENOSIS. 478 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND VERY LATE THROMBOSIS IN THE PROXIMAL PORTION OF THE BRS. THE AREA WAS TREATED WITH THROMBUS ASPIRATION AND BALLOON DILATATION AND A DRUG ELUTING STENT WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/06/2020;07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04959", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20181211", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200611", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200611", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aneurysm", "Myocardial Infarction", "Tachycardia", "Thrombosis", "Ventricular Tachycardia" ] } ], "distributor_city": "", "date_report": "20200731", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10146638", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195266103", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATE, DIAGNOSIS, IMPLANT: DATES ARE ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195266104", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST- ELEVATED MYOCARDIAL INFARCTION (STEMI) AND HAD A 3.5X28 MM ABSORB BIORESORBABLE SCAFFOLD (BRS) IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. SIX MONTHS FOLLOW UP SHOWED A FAVORABLE RESULT. 1440 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH A NSTEMI AND RECURRENT NON-SUSTAINED VENTRICULAR TACHYCARDIA. ANGIOGRAPHY WITH OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED VERY LATE SCAFFOLD THROMBOSIS WITH THROMBOTIC MATERIAL AND FORMATION OF A LARGE ANEURYSM IN THE REGION OF THE IMPLANTED BRS. THE LESION WAS TREATED WITH A DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ATTACHED ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" }, { "mdr_text_key": "318840891", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318663216", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION, ANEURYSM, THROMBOSIS AND TACHYCARDIA, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.H6: PATIENT CODE 2132 REMOVED - ATTACHMENT: [ARTICLE SCAFFOLD THROMBOSIS.PDF]." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/07/2020;07/31/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04960", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170605", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/16/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "ABSORB BRS", " ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10148266", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318860628", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION, STENOSIS AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.B1 - ATTACHMENT: [CN-033801 ARTICLE.PDF]." }, { "mdr_text_key": "194966466", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE TITLED, VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "194966467", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND WAS TREATED WITH TWO 3.5X28 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IN THE RIGHT CORONARY ARTERY (RCA). FOLLOW UP ANGIOGRAPHY AT 15 MONTHS POST IMPLANT SHOWED A SATISFACTORY RESULT. 866 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI CAUSED BY VERY LATE SCAFFOLD THROMBOSIS. HEPARIN WAS GIVEN. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED THROMBOTIC MATERIAL SURROUNDING MALPOSED STRUTS IN THE LUMEN OF THE DISTAL RCA AT THE SITE OF SCAFFOLD DISCONTINUITY. THE AREA WAS TREATED WITH A DRUG ELUTING STENT WITH A GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04965", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190203", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "ABSORB BRS", " ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10148581", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318867540", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. (B)(4)." }, { "mdr_text_key": "194971750", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "194971751", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A 3.0X18 MM AND A 3.5X12 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IN THE LEFT CIRCUMFLEX CORONARY ARTERY. SIX MONTH FOLLOW UP SHOWED A FAVORABLE RESULT. 1494 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND ANGIOGRAPHY SHOWED VERY LATE SCAFFOLD THROMBOSIS WITH THROMBOTIC OCCLUSION OF THE BRS. THE AREA WAS TREATED WITH BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT (SES). NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04966", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190203", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "ABSORB BRS", " ABSORB BRS" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10148611", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318766695", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [CN-033974.PDF]" }, { "mdr_text_key": "195022701", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. THE ADDITIONAL ABSORB DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY." }, { "mdr_text_key": "195022702", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A 3.0X18 MM AND A 3.5X12 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IN THE LEFT CIRCUMFLEX CORONARY ARTERY. SIX MONTH FOLLOW UP SHOWED A FAVORABLE RESULT. 1494 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND ANGIOGRAPHY SHOWED VERY LATE SCAFFOLD THROMBOSIS WITH THROMBOTIC OCCLUSION OF THE BRS. THE AREA WAS TREATED WITH BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT (SES). NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-04976", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200612", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170605", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200612", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200612", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/16/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230822", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200612", "sequence_number_treatment": [ "ABSORB BRS." ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10148904", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200519", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318871947", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "318659413", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "195098065", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. IT CANNOT BE CONFIRMED IF THE DEVICE WAS ABSORB OR ABSORB GT1. ARTICLE TITLED: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHYNA." }, { "mdr_text_key": "195098066", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING WAS REPORTED THROUGH A RESEARCH ARTICLE: IT WAS REPORTED THAT THE PATIENT PRESENTED WITH NON ST ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND WAS TREATED WITH 2 3.5X28 MM ABSORB BIORESORBABLE SCAFFOLDS (BRS) IN THE RIGHT CORONARY ARTERY (RCA). FOLLOW UP ANGIOGRAPHY AT 15 MONTHS POST IMPLANT SHOWED A SATISFACTORY RESULT. 866 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI CAUSED BY VERY LATE SCAFFOLD THROMBOSIS. HEPARIN WAS GIVEN. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED THROMBOTIC MATERIAL SURROUNDING MALAPPOSED STRUTS IN THE LUMEN OF THE DISTAL RCA AT THE SITE OF SCAFFOLD DISCONTINUITY. THE AREA WAS TREATED WITH A DRUG ELUTING STENT WITH A GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED. DETAILS ARE IN THE ARTICLE, TITLED: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/01/2020;07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05136", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200618", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200618", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200618", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/18/2020;07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230818", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection", "Ischemia", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200724", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10167460", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200609", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318694914", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "195561388", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, ISCHEMIA AND DISSECTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE XIENCE DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT#. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT #S WERE NOT PROVIDED. LITERATURE TITLE: BIORESORBABLE VASCULAR SCAFFOLDS VERSUS DRUG-ELUTING STENTS FOR DIFFUSE LONG CORONARY NARROWINGS." }, { "mdr_text_key": "195561389", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING UNK ABSORB THAT MAY BE RELATED TO THE FOLLOWING: DELIVERY FAILURE, DISSECTION, MYOCARDIAL INFARCTION, THROMBOSIS, ISCHEMIA, AND REVASCULARIZATION. ADDITIONALLY, THE ARTICLE IDENTIFIED UNK XIENCE THAT MAY BE RELATED TO THE FOLLOWING: DELIVERY FAILURE, DEATH, MYOCARDIAL INFRACTION, THROMBOSIS, ISCHEMIA, AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED: BIORESORBABLE VASCULAR SCAFFOLDS VERSUS DRUG-ELUTING STENTS FOR DIFFUSE LONG CORONARY NARROWINGS." }, { "mdr_text_key": "318664456", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NAH6: METHOD CODE 4111 REMOVED - [(B)(4)]." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/08/2020;07/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "NJ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "P.O. BOX 151, ROUTE 22 WEST", "manufacturer_contact_pcity": "90821834", "event_type": "Injury", "report_number": "2210968-2020-04645", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200618", "manufacturer_address_2": "", "pma_pmn_number": "N12159", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "08876", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9082183429", "noe_summarized": "1", "manufacturer_contact_l_name": "BELLO", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "908", "date_added": "20200618", "manufacturer_contact_f_name": "ELBA", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200618", "brand_name": "SURGICEL ORIGINAL 2INX14IN(5.1CMX35.6CM)", "generic_name": "AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED", "manufacturer_d_name": "ETHICON INC.", "manufacturer_d_address_1": "P.O. BOX 151, ROUTE 22 WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "SOMERVILLE", "manufacturer_d_state": "NJ", "manufacturer_d_zip_code": "08876", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "08876", "device_operator": "HEALTH PROFESSIONAL", "model_number": "1951", "catalog_number": "1951", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LMG", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10705031003019", "udi_public": "10705031003019", "openfda": { "registration_number": [ "2210968" ], "fei_number": [ "2210968" ], "device_name": "Agent, Absorbable Hemostatic, Non-Collagen Based", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4490", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200928", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9082", "patient": [ { "patient_sequence_number": "1", "date_received": "20200618", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "54 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Not Applicable", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200604", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SOMERVILLE", "mdr_report_key": "10169874", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ETHICON INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195729351", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DATE AND NAME OF INDEX SURGICAL PROCEDURE? THE DATE IS UNKNOWN. THE PROCEDURE IS RENAL TRANSPLANTATION. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? NO FURTHER INFORMATION IS AVAILABLE. RELEVANT PATIENT HISTORY? FOCAL SEGMENTAL GLOMERULOSCLEROSIS(FSGS). 20 YEARS OF DIALYSIS. ANY CONCURRENT USE OF OTHER PRODUCTS? TISSUE ADHESIVE SHEET (TACO SEAL). LOT #? NO FURTHER INFORMATION IS AVAILABLE. WHAT WAS THE INTENDED USE OF THE SURGICEL? USED FOR HEMOSTASIS AND NO FURTHER INFORMATION IS AVAILABLE. WHERE WAS THE SURGICEL USED (ON WHAT TISSUE)? NO FURTHER INFORMATION IS AVAILABLE. HOW MUCH SURGICEL WAS USED DURING THE PROCEDURE? NO FURTHER INFORMATION IS AVAILABLE. WAS THE SURGICEL PRODUCT LEFT IN PLACE? WAS THE EXCESS IRRIGATED AND REMOVED? NO FURTHER INFORMATION IS AVAILABLE. WHAT WERE CURRENT SYMPTOMS FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? NO FURTHER INFORMATION IS AVAILABLE. HAS ANY SURGICAL OR MEDICAL INTERVENTION BEEN PERFORMED? URETERAL STENT WAS PLACED AND URETERAL TRANSPLANT WAS PERFORMED. WHAT IS PHYSICIAN\u00bfS OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? THE SURGEON COMMENTED THAT STRICTURE DUE TO URETERAL ISCHEMIA MAY BE CONSIDERED, WHEN OBSERVED BY NAKED EYES. BUT \u00bfTHE SIDE EFFECT\u00bf OF THE PACKAGE INSERT ON THE SURGICEL IS DESCRIBED AS FOREIGN BODY REACTION SUCH AS URETERAL OBSTRUCTION, AND STRICTURE DUE TO THIS SURGICEL EFFECT WAS ALSO CONSIDERED. WAS THERE AN ALLEGED DEFICIENCY OF THE SURGICEL THAT CONTRIBUTED TO THE PATIENT\u00bfS POST-OPERATIVE URETERAL STENOSIS AND HYDRONEPHROSIS? NO FURTHER INFORMATION IS AVAILABLE. WHAT IS THE PATIENT\u00bfS CURRENT STATUS? NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION WILL BE PROVIDED." }, { "mdr_text_key": "195729352", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A PATIENT UNDERWENT A RENAL TRANSPLANTATION PROCEDURE ON UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. URETERAL STENOSIS AND HYDRONEPHROSIS WERE FOUND POSTOPERATIVELY, AND A URETERAL STENT WAS PLACED. THE URETERAL STENOSIS DID NOT IMPROVE EVEN AFTER TRANSURETHRAL DILATATION OF THE URETER, AND ONE YEAR AFTER THE TRANSPLANTATION, A TRANSPLANTED URETER AND AN AUTOURETERAL ANASTOMOSIS WERE PERFORMED. THE SURGEON OPINES STRICTURE DUE TO URETERAL ISCHEMIA MAY BE CONSIDERED, WHEN OBSERVED BY NAKED EYES. BUT THE SIDE EFFECT OF THE PACKAGE INSERT ON THE ABSORBABLE HEMOSTAT IS DESCRIBED AS FOREIGN BODY REACTION SUCH AS URETERAL OBSTRUCTION, AND STRICTURE DUE TO THIS ABSORBABLE HEMOSTAT EFFECT WAS ALSO CONSIDERED. ADDITIONAL INFORMATION WAS REQUESTED" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "08876", "manufacturer_contact_exchange": "908", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-05199", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Off-Label Use" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/06/2020", "manufacturer_contact_country": "", "date_changed": "20230512", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "64 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Sepsis" ] } ], "distributor_city": "", "date_report": "20200723", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10178962", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "315066405", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. IN THIS ARTICLE, THE BVS WAS USED IN THE LOWER EXTREMITIES. IT SHOULD BE NOTED THAT THE DEVICE IFU STATES: THE ABSORB BVS IS A TEMPORARY SCAFFOLD INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER THAT WILL EVENTUALLY RESORB AND POTENTIALLY FACILITATE NORMALIZATION OF VESSEL FUNCTION IN PATIENTS WITH ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI # IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. PATIENT CODE: SEPSIS ADDED. (B)(4)." }, { "mdr_text_key": "195929320", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF DEATH ESTIMATED AS (B)(6) 2018. DATE OF EVENT ESTIMATED AS (B)(6) 2018. DATE OF IMPLANT ESTIMATED AS (B)(6) 2017. (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL ADVERSE EVENTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. ARTICLE TITLE: EARLY AND MIDTERM EXPERIENCE WITH THE ABSORB EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD IN ASIAN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA: ONE-YEAR CLINICAL AND IMAGING OUTCOMES FROM THE DISAPPEAR REGISTRY." }, { "mdr_text_key": "195929321", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED EARLY AND MIDTERM EXPERIENCE WITH THE ABSORB EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD IN ASIAN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA: ONE-YEAR CLINICAL AND IMAGING OUTCOMES FROM THE DISAPPEAR REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/23/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05200", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Off-Label Use" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/06/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "64 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stenosis" ] } ], "distributor_city": "", "date_report": "20200723", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10178985", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318843641", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. IT SHOULD BE NOTED THAT THE IFU STATES: THE ABSORB BVS IS A TEMPORARY SCAFFOLD INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER THAT WILL EVENTUALLY RESORB AND POTENTIALLY FACILITATE NORMALIZATION OF VESSEL FUNCTION IN PATIENTS WITH ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED DIFFICULTY. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AND THE PART AND LOT # WERE NOT PROVIDED." }, { "mdr_text_key": "195925695", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT ESTIMATED AS (B)(6) 2018. DATE OF IMPLANT ESTIMATED AS (B)(6) 2017. (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE PATIENT DEATH(S) REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. LITERATURE ARTICLE TITLE: EARLY AND MIDTERM EXPERIENCE WITH THE ABSORB EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD IN ASIAN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA: ONE-YEAR CLINICAL AND IMAGING OUTCOMES FROM THE DISAPPEAR REGISTRY." }, { "mdr_text_key": "195925696", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO DEATH AND SERIOUS INJURY. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED EARLY AND MIDTERM EXPERIENCE WITH THE ABSORB EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD IN ASIAN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA: ONE-YEAR CLINICAL AND IMAGING OUTCOMES FROM THE DISAPPEAR REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/23/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05209", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180706", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20180401", "model_number": "1235300-18", "catalog_number": "1235300-18", "lot_number": "6100461", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "08717648213045", "udi_public": "08717648213045", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/31/2020;11/02/2020;12/15/2020", "manufacturer_contact_country": "", "date_changed": "20230807", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "1 IMPLANTED ABSORB SCAFFOLD." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "77 YR", "patient_sex": "", "patient_weight": "62", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Stenosis" ] } ], "distributor_city": "", "date_report": "20201222", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10179822", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200529", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196074605", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "196074606", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2017, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE DISTAL RIGHT CORONARY ARTERY (RCA) LESION. FOLLOWING PRE-DILATATION, A 3.0X18MM ABSORB GT1 SCAFFOLD (1235300-18, 6100461) WAS SUCCESSFULLY IMPLANTED IN THE DISTAL RCA. ON (B)(6) 2017, ANOTHER PCI WAS PERFORMED. FOLLOWING PRE-DILATATION, A 3.0X23MM ABSORB SCAFFOLD (1235300-23, 6101161) WAS SUCCESSFULLY IMPLANTED IN THE 1ST DIAGONAL CORONARY ARTERY. THERE WERE NO ADVERSE EVENTS AND THERE WAS NO DEVICE MALFUNCTION. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED. A CORONARY ANGIOGRAM WAS PERFORMED AND SILENT MYOCARDIAL ISCHEMIA DIAGNOSED. THE DISTAL RCA, 3.0X18MM ABSORB SCAFFOLD, WAS OBSERVED WITH RESTENOSIS AND A FLARED STRUT. AS TREATMENT, AN ATHERECTOMY WAS PERFORMED. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO RESTENOSIS AND NO DEVICE ISSUE REGARDING THE 1ST DIAGONAL, 3.0X23MM ABSORB SCAFFOLD. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE." }, { "mdr_text_key": "320504764", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: THIS PATIENT EVENT WAS ALSO CAPTURED IN A PUBLISHED ARTICLE TITLED \" OVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION\u00bf IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE 3.0X18MM ABSORB GT1 SCAFFOLD WAS IMPLANTED WITHOUT A DEVICE ISSUE. PER OPTICAL COHERENCE TOMOGRAPHY, THE SCAFFOLD WAS COMPLETELY EMBEDDED IN THE VASCULAR ENDOTHELIUM. 12 MONTHS LATER AND PER IMAGING, THERE WAS NO RESTENOSIS, HOWEVER, THERE WAS DISCONTINUITY OF THE BVS AND SOME STRUTS APART FROM THE VESSEL. TORN STRUTS OVERHANGING INTO THE VASCULAR LUMEN, REMAINING STATIONARY ON THE ENDOTHELIUM AND RESISTANT TO CORONARY BLOOD FLOW WERE ALSO OBSERVED. DURING A FOLLOW-UP CATHERIIZATION, THE VESSEL WALL OF THE PROXIMAL SITE OF THE OVERHANGING BVS SHOWED POSITIVE REMODELING AND THERE WERE NO ATTACHED STRUTS. THE PHYSICIANS SPECULATE THAT PROMPT POSITIVE REMODELING CAUSED EARLY DISLODGEMENT AND SCHEDULED DEGENERATION OF THE DISLODGED STRUTS CAUSING THEM TO ROLL UP AND FALL ONTO THE DISTAL SIDE. DUAL ANTIPLATELET THERAPY WAS PROVIDED WITHOUT ANY ADVERSE EVENTS FOR 2 YEARS AFTER PCI.. DETAILS ARE FOUND IN THE ATTACHED ARTICLE: \u00bfOVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION\u00bf" }, { "mdr_text_key": "320504765", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE REMAINED IMPLANTED AND IS NOT RETURNING FOR ANALYSIS. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED REPORTING ADDITIONAL, RELEVANT INFORMATION. LITERATURE ATTACHED: \u00bfOVERHANGING BIORESORBABLE VASCULAR SCAFFOLD OBSERVED ON ANGIOSCOPY 1 YEAR AFTER IMPLANTATION\u00bfB3: ESTIMATED DATE. THE ARTICLE REPORTS A NEW DATE OF OCCURRENCE AS ONE YEAR FOLLOWING THE INDEX PROCEDURE WHICH WAS PERFORMED ON (B)(6)2017. THE DATE OF OCCURRENCE HAS BEEN ESTIMATED AS (B)(6)2018." }, { "mdr_text_key": "320505031", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED:(B)(6)2018 DISCONTINUITY OF THE BVS AND SOME STRUTS APART FROM THE VESSEL WERE OBSERVED." }, { "mdr_text_key": "320505032", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.B3: ACTUAL DATE OF EVENT." }, { "mdr_text_key": "319286115", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND RESTENOSIS AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD SYSTEM, ABSORB, INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.B6:(B)(6)2019 : CORONARY ANGIOGRAM REMOVED AND REPLACED WITH THE CORRECT YEAR, (B)(6)2017 ." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/04/2020;11/19/2020;12/22/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05227", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200622", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140106", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200622", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200622", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Improper or Incorrect Procedure or Method", "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/24/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200622", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200728", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10181608", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318840498", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2: MEAN AGE. A3: MAJORITY. B3, D6: ESTIMATED. D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS AND RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. IT SHOULD BE NOTED THAT THE IFU STATES: SIZE THE REFERENCE TARGET LESION DIAMETER APPROPRIATELY TO AVOID OVER EXPANDING THE SCAFFOLD TO ENSURE ADEQUATE SCAFFOLD APPOSITION. THIS WILL REDUCE THE RISK OF CAUSING SCAFFOLD DAMAGE. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT: \"EVEROLIMUS-ELUTING BIORESORBABLE STENT VS. DURABLE POLYMER EVEROLIMUS-ELUTING METALLIC STENT IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: RESULTS OF THE RANDOMIZED ABSORB ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION\u00bf TROFI II TRIAL\"." }, { "mdr_text_key": "196073978", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE: MEAN AGE, SEX: MAJORITY, DATE OF EVENT AND IMPLANT: ESTIMATED. THE DEVICE REMAINS IMPLANTED AND WILL NOT RETURN. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED WITH ADDITIONAL, RELEVANT INFORMATION. THE ABSORB DEVICE IS NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE XIENCE XPEDITION DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "196073979", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE ABSORB SCAFFOLD AND THE XIENCE XPEDITION STENT MAY BE RELATED TO RESTENOSIS, MALAPPOSITION, AND TARGET LESION REVASCULARIZATION. ABSORB ONLY: A SUBACUTE THROMBOSIS WHICH LEAD TO A MYOCARDIAL INFARCTION (MI) AND REVASCULARIZATION. REPORTEDLY, THIS WAS DUE TO INADEQUATE MATCHING OF THE VESSEL SIZE AND DEVICE SELECTED (VESSEL SIZE WAS 1.92MM AND SCAFFOLD SELECTED WAS 2.5MM). SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS PROVIDED IN THE ATTACHED ARTICLE TITLED: \u00bfEVEROLIMUS-ELUTING BIORESORBABLE STENT VS. DURABLE POLYMER EVEROLIMUS-ELUTING METALLIC STENT IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: RESULTS OF THE RANDOMIZED ABSORB ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION\u00bf TROFI II TRIAL.\u00bf" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/28/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05254", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200623", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20200201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200623", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200623", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "UNK", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Migration" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/08/2020", "manufacturer_contact_country": "", "date_changed": "20230718", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200623", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "77 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Vessel Or Plaque, Device Embedded In", "Angina", "Embolism", "Ischemia" ] } ], "distributor_city": "", "date_report": "20200813", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10185089", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200604", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196115333", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE REMAINED IMPLANTED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ADDITIONAL INFORMATION. THE ABSORB DEVICE IS NOT COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. LITERATURE, TITLED: MIGRATED REMNANT BIORESORBABLE SCAFFOLDS IN A LEFT MAIN BIFURCATION LESION: INSIGHTS FROM OPTICAL COHERENCE TOMOGRAPHY." }, { "mdr_text_key": "196115334", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN INDIVIDUAL CASE REPORT WAS OBTAINED FROM AN ARTICLE TITLED \u00bfMIGRATED REMNANT BIORESORBABLE SCAFFOLDS IN A LEFT MAIN BIFURCATION LESION: INSIGHTS FROM OPTICAL COHERENCE TOMOGRAPHY\u00bf. IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, A 3.5X28MM AND 3.0X28MM ABSORB SCAFFOLDS WERE IMPLANTED IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. A 3.0X18MM ABSORB SCAFFOLD WAS IMPLANTED IN THE DISTAL LEFT CIRCUMFLEX (CX) CORONARY ARTERY LESION. THREE YEARS LATER, THE PATIENT PRESENTED WITH EXERTIONAL CHEST PAIN. IMAGING WAS PERFORMED. THE LAD REMAINED PATENT, HOWEVER, SEVERE STENOSIS WAS OBSERVED IN THE PROXIMAL LCX WITH VERTICAL FILING DEFECT WITHIN THE LEFT MAIN (LM) CORONARY ARTERY. SCAFFOLD REMNANTS WERE OBSERVED IN THE LM BIFURCATED LESION. AS TREATMENT, TWO XIENCE SIERRA STENTS WERE SUCCESSFULLY IMPLANTED. FINAL ANGIOGRAPHY DISPLAYED GOOD DISTAL FLOW WITHOUT RESIDUAL STENOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE." }, { "mdr_text_key": "319227220", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3, D6: ESTIMATED DATE. D4: UNIQUE DEVICE IDENTIFIER (UDI): IN THE ABSENCE OF REPORTED PART NUMBER, UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF ANGINA, ISCHEMIA AND EMBOLISM, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHMENT: LITERATURE, TITLED: MIGRATED REMNANT BIORESORBABLE SCAFFOLDS IN A LEFT MAIN BIFURCATION LESION: INSIGHTS FROM OPTICAL COHERENCE TOMOGRAPHY.NA - ATTACHMENT: [E-29130 ARTICLE NMS.PDF]." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/13/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Death", "report_number": "2024168-2020-05263", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200623", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200623", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200623", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230623", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200623", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10185918", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196144642", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, DIAGNOSIS, AND IMPLANT: DATES ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, IS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT #." }, { "mdr_text_key": "196144783", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB BIORESORBABLE VASCULAR SCAFFOLDS (BVS) THAT MAY BE RELATED TO THE PATIENT EFFECTS OF DEATH, MYOCARDIAL INFARCTION (MI), TARGET LESION REVASCULARIZATION AND LATE SCAFFOLD THROMBOSIS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF EVEROLIMUS- AND BIOLIMUS-ELUTING CORONARY STENTS WITH EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS: TWO-YEAR CLINICAL OUTCOMES OF THE EVERBIO II TRIAL\" ." }, { "mdr_text_key": "315220012", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-05265", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200623", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20170101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200623", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200623", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200623", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10185925", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200602", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318868055", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [CN-034160.PDF]." }, { "mdr_text_key": "196224913", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION, ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. ARTICLE TITLED \"COMPARISON OF EVEROLIMUS- AND BIOLIMUS-ELUTING CORONARY STENTS WITH EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS: TWO-YEAR CLINICAL OUTCOMES OF THE EVERBIO II TRIAL\"." }, { "mdr_text_key": "196224914", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB BIORESORBABLE VASCULAR SCAFFOLDS (BVS) THAT MAY BE RELATED TO THE PATIENT EFFECTS OF DEATH, MYOCARDIAL INFARCTION (MI), TARGET LESION REVASCULARIZATION AND LATE SCAFFOLD THROMBOSIS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF EVEROLIMUS- AND BIOLIMUS-ELUTING CORONARY STENTS WITH EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS: TWO-YEAR CLINICAL OUTCOMES OF THE EVERBIO II TRIAL\" ." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/30/2020" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05978", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296006", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199499373", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199499374", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED 3X18MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS THAT SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05983", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121202", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296212", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199539101", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199539102", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED 3.5X18MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 1 DAY LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-05991", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200720", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130307", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200720", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200720", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200720", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200720", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10296272", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199550261", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199550262", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. AN UNSPECIFIED 3X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 96 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06040", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200721", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200721", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200721", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200721", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10301430", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199690480", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: DATES ARE ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199690481", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. AN UNSPECIFIED 3.5X28MM ABSORB BIODEGRADABLE SCAFFOLD WAS IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS THAT SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06041", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200721", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121214", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200721", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200721", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200721", "sequence_number_treatment": [ "3.5X12MM ABSORB" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200721", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10301894", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199704936", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON." }, { "mdr_text_key": "199704937", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING AN ABSORB SCAFFOLD THAT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. TWO UNSPECIFIED 3.5X12MM ABSORB BIODEGRADABLE SCAFFOLDS WERE IMPLANTED. THE PATIENT DEVELOPED THROMBOSIS 13 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-06124", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200722", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200722", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200725", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10311134", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199983700", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL XIENCE V AND RX MULTILINK DEVICES REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "199983701", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE V, AND MULTILINK THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 870 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS, XIENCE V, AND MULTILINK STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06127", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200722", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20121201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200722", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200722", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200722", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200722", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10311258", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200629", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199985645", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PATIENT DEATHS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE ADDITIONAL XIENCE V AND RX MULTILINK DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED THROMBOSIS AND MYOCARDIAL INFARCTION AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US." }, { "mdr_text_key": "199985646", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE V, AND MULTILINK THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 870 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS, XIENCE V, AND MULTILINK STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"ABSORB BIORESORBABLE VASCULAR SCAFFOLD VERSUS EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 1-YEAR RESULTS OF A PROPENSITY SCORE MATCHING COMPARISON.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06408", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200803", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20200721", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "951", "date_added": "20200803", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200803", "brand_name": "ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20161107", "model_number": "", "catalog_number": "1234300-12", "lot_number": "5051361", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200803", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina", "Stenosis", "Test Result" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10355882", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200721", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201873242", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ABSORB GT1 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "201873243", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text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} ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-06409", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200803", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20200721", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "951", "date_added": "20200803", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200803", "brand_name": "ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20160726", "model_number": "", "catalog_number": "1234350-18", "lot_number": "5072861", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200914", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200803", "sequence_number_treatment": [ "3X12MM ABSORB GT1" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina", "Stenosis", "Test Result" ] } ], "distributor_city": "", "date_report": "20200803", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10356069", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200721", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "201369234", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ABSORB GT1 REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "201369235", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text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} ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CT", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MERCEDITA", "manufacturer_contact_address_1": "195 MCDERMOTT RD.", "manufacturer_contact_pcity": "20349262", "event_type": "Injury", "report_number": "2647580-2008-00245", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080502", "manufacturer_address_2": "", "pma_pmn_number": "K010909", "date_of_event": "20080320", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "06473", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "2034926273", "noe_summarized": "1", "manufacturer_contact_l_name": "CALLAHAN", "source_type": [ "Foreign", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "00715", "manufacturer_g1_state": "PR", "reporter_country_code": "AU", "manufacturer_contact_area_code": "203", "date_added": "20080508", "manufacturer_contact_f_name": "TERRY", "device_date_of_manufacturer": "20070901", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080502", "brand_name": "SURGIPRO 6/0", "generic_name": "NON-ABSORBABLE SYNTHETIC SUTURE", "manufacturer_d_name": "PONCE - USS", "manufacturer_d_address_1": "SABANETAS INDUSTRIAL PARK", "manufacturer_d_address_2": "", "manufacturer_d_city": "MERCEDITA", "manufacturer_d_state": "PR", "manufacturer_d_zip_code": "00715", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "00715", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20120930", "model_number": "", "catalog_number": "VP706X", "lot_number": "T7J0214JMV", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GAO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Suture, Nonabsorbable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4495", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080508", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "2034", "patient": [ { "patient_sequence_number": "1", "date_received": "20080502", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "UNK", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080407", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "NORTH HAVEN", "mdr_report_key": "1036652", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "00715", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "PONCE - USS", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "853708", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PROCEDURE TYPE: STENT PLACEMENT. ACCORDING TO THE REPORTER: THE STENT WAS SUTURED AND THE ANASTOMOSIS WAS CLOSED. THE CLAMP WAS OPENED AND THE SUTURE COULD NOT RESIST THE TENSION AND BROKE OFF. THE ANASTOMOSIS CAME UNDONE. NO FURTHER INFO COULD BE OBTAINED ABOUT THIS EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "SABANETAS INDUSTRIAL PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "06473", "manufacturer_contact_exchange": "203", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FLAGSTAFF", "manufacturer_contact_address_1": "1505 N. FOURTH STREET", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "2017233-2020-01099", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200810", "manufacturer_address_2": "", "pma_pmn_number": "K063435", "date_of_event": "20070112", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "86004", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "REIGH", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "86005", "manufacturer_g1_state": "AZ", "reporter_country_code": "US", "manufacturer_contact_area_code": "928", "date_added": "20200810", "manufacturer_contact_f_name": "MEGAN", "device_date_of_manufacturer": "20011018", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200810", "brand_name": "GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL", "generic_name": "MESH, SURGICAL, POLYMERIC", "manufacturer_d_name": "W. L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "1505 N. FOURTH STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86004", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86004", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20031018", "model_number": "1DLMCP04", "catalog_number": "1DLMCP04", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FTL", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "00733132601110", "udi_public": "00733132601110", "openfda": { "device_name": "Mesh, Surgical, Polymeric", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/30/2020;07/30/2020;07/18/2022;07/18/2022", "manufacturer_contact_country": "US", "date_changed": "20240201", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200810", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "48 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230224", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "10385709", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200730", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "86005", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL WOODY MOUNTAIN B/P", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "325506027", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RELEVANT MEDICAL INFORMATION: ON (B)(6) 2006: (B)(6) HOSPITAL. (B)(6), MD. PROCEDURE REPORT. PREOPERATIVE DIAGNOSIS: HISTORY OF PERFORATED DIVERTICULITIS, NOW STATUS POST COLOSTOMY, TENSION TO COLOSTOMY. POSTOPERATIVE DIAGNOSIS: HISTORY OF PERFORATED DIVERTICULITIS, NOW STATUS POST COLOSTOMY, TENSION TO COLOSTOMY. SCANT NEOSIGMOID DIVERTICULA. PROCEDURE: COLONOSCOPY VIA STOMA AS WELL AS FLEXIBLE SIGMOIDOSCOPY. COMPLICATIONS: NONE. ANESTHESIA: GENERAL. COMPLICATIONS: NONE. SPECIMENS: PORTION OF COLON. PACKINGS/DRAINS: AQUACEL AQ PACKING TO THE OLD COLOSTOMY SITES. BLOOD LOSS: APPROXIMATELY 100 CC. OTHER DRAIN: BLAKE DRAIN IN THE PELVIS. OPERATIVE FINDING AND TECHNIQUE: WITH CONSENT PATIENT BROUGHT TO THE OPERATING SUITE, PLACED IN SUPINE POSITION. FOLLOWING GENERAL ANESTHESIA SHE WAS PLACED IN LITHOTOMY POSITION. DR. CHAO THEN PLACED URETERAL STENTS WITHOUT ANY DIFFICULTY. THE ABDOMEN WAS THEN PREPPED AND DRAPED AFTER THE COLOSTOMY WAS SEWN CLOSED. MIDLINE LAPAROTOMY WAS PERFORMED. EXTENSIVE INTRAABDOMINAL ADHESIONS WERE UNDERTAKEN. EXTENSIVE LYSED OF ADHESIONS WAS UNDERTAKEN. ULTIMATELY THE COLOSTOMY WAS IDENTIFIED AND THE COLOSTOMY WAS BROUGH DOWN BACK TO THE COLOSTOMY OPENING INTO THE PERITONEAL CAVITY. THE FASCIA OF THE OLD COLOSTOMY SITE WAS CLOSED WITH 0 VICRYL SUTURE IN INTERRUPTED FIGURE-OF-EIGHT FASHION. PER THE DISSECTION THE PELVIS REVEALED A LONG SIGMOID RECTAL STUMP. THIS WAS DISSECTED DOWN TOWARDS THE RECTAL WALL AND RECTAL WALL CIRCUMFERENTIALLY FREED UP. THE CONTOUR STAPLER WAS USED TO STAPLE ACROSS THE PROXIMAL RECTUM AND THIS WAS ACHIEVED WITHOUT INCIDENCE AS WELL. APPROPRIATE AMOUNT OF LENGTH OF THE COLON WAS UNDERTAKEN. THIS REQUIRED RESECTION OF A FURTHER PORTION OF COLON AS PORTION HAD BECOME DEVASCULARIZED SECONDARY TO POOR BLOOD SUPPLY AND POOR WATER SHED CIRCULATION. THE COLON WAS TAKEN BACK TO THE TRANSVERSE COLON. THE COLON WAS FREED UP SO THAT IF FLOPPED NICELY INTO THE PELVIS WITHOUT ANY EVIDENCE OF TENSION. THERE WAS EXCELLENT BLEEDING FROM PROXIMAL AND DISTAL ANASTOMOTIC SITES. PRESSURING DEVICE WAS PLACED AROUND THE PROPOSED PROXIMAL ANASTOMOTIC SITE. SIZES WERE USED AND IT FIT A 29 EEA SIZER SNUGLY. THIS WAS CHOSEN FOR THE ANASTOMOSIS AND THE ANVIL WAS PLACED DOWN TO THE PROXIMAL COLON. IT WAS SECURED WITH THE PRESSURING DEVICE. AN ASSISTANT THEN WENT INTO THE PERONEAL AREA AFTER SERIAL DILATAGE OF THE ANAL RECTAL CANAL. THE 29 EEA STAPLER WAS PLACED THROUGH THE RECTAL CANAL. THE POST WAS OPENED, BROUGHT OUT THE STAPLE LINE FROM THE RECTAL STUMP AND THE ANVIL WAS ATTACHED TO THE POST. STAPLER WAS FIRED. SUTURE LINE WAS IMBRICATED WITH 3-0 SILK SUTURE WHICH PROCEEDED WITHOUT INCIDENT. THE ABDOMINAL CAVITY WAS IRRIGATED AND DRIED. THE ABDOMINAL CAVITY WAS FILLED WITH SALINE AND THEN THE RIGID PROCTOSIGMOIDOSCOPE WAS PLACED IN THE ANAL CANAL AND THE COLON WAS INSUFFLATED. THERE WAS NO BUBBLING, NO AIR LEAK. THE ANASTOMOSIS WAS SECURE. ABDOMINAL CAVITY WAS SUCTIONED AND DRIED. A BLAKE DRAIN HAD BEEN PLACED IN THE PELVIS. THIS WAS PLACED TOWARD THE ANASTOMOSIS. DURING THE COURSE OF THE PROCEDURE THE SPLENIC FLEXURE REQUIRED MOBILIZATION. ABDOMINAL CAVITY WAS IRRIGATED AGAIN. HEMOSTASIS HAD BEEN ACHIEVED. SEPRAFILM WAS PLACED IN THE ABDOMINAL CAVITY. MUSCULAR FASCIAL LAYERS THEN CLOSED WITH 1-PDS IN RUNNING LOOP FASHION. SKIN INCISION OF THE MIDLINE WAS CLOSED WITH STAPLES. LEFT UPPER QUADRANT INCISION WAS CLOSED INTERMITTENTLY WITH STAPLES AND INTERMITTENTLY PACKED WITH AQUACEL AQ. THIS PROCEEDED WITHOUT INCIDENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH FINDINGS AS DESCRIBED. AT TERMINATION OF THE PROCEDURE ALL INSTRUMENTS, SPONGE AND NEEDLE COUNTS WERE CORRECT. FINAL PATHOLOGY IS PENDING AT TIME OF THIS DICTATION.\u00bf EXPLANT PROCEDURE: LAPAROTOMY AND EXCISION OF INFECTED ABDOMINAL MESH. EXPLANT DATE: (B)(6) 2007 (HOSPITALIZATION [NI] [NOT INDICATED]) ON (B)(6) 2007: (B)(6) MEDICAL CENTER. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INFECTED ABDOMINAL MESH. POSTOPERATIVE DIAGNOSIS: INFECTED ABDOMINAL MESH. ASSISTANT: (B)(6), MD. ANESTHESIA: GENERAL INHALATION ANESTHESIA. PLEASE NOTE I, DR. (B)(6) , WAS PRESENT AND PERFORMED/SUPERVISED THE ENTIRE CASE. OPERATIVE COURSE: \u00bfAFTER THE PATIENT WAS SUITABLY IDENTIFIED, SHE WAS POSITIONED, PREPPED AND DRAPED. THE DRAINING SITE OF PURULENCE WAS OBVIOUS AND A KELLY CLAMP WAS PUT INTO THIS DOWN INTO THE ABDOMINAL CAVITY. THE SKIN, SUBCUTANEOUS TISSUE AND FASCIA WERE EXCISED FOR A DISTANCE ADEQUATE TO VISUALIZE THE GORE-TEX MESH IN THIS CAVITY. THIS MESH WAS THEN GRASPED AND WORKED OUT FROM SIDE TO SIDE UNTIL IT APPEARED TO HAVE ALL BEEN REMOVED. IT WAS TORN, BUT CAREFUL PALPATION OF THE CAVITY SUGGESTED THERE WAS NO RESIDUAL MESH IN THIS CAVITY. A SMALLER WOUND MORE SUPERFICIAL THAT WAS DRAINING WAS INCISED AND DID NOT APPEAR TO COMMUNICATE DIRECTLY WITH THIS CAVITY, IT WAS OPENED WIDELY AND PACKED. BOTH CAVITIES WERE PACKED, THE FASCIAL DEFECT WAS LEFT OPEN, BUT THE BOWEL APPEARED TO BE WELL SOLIDIFIED BENEATH THIS AND DID NOT EVISCERATE. THE PATIENT WAS AWAKENED AND TRANSPORTED TO THE RECOVERY ROOM IN GOOD CONDITION.\u00bf SEE ATTACHMENT FOR H10/11 CONTINUATION." }, { "mdr_text_key": "331063317", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED INVESTIGATION FINDINGS CODE. CONCLUSION CODE REMAINS UNCHANGED. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE. THE GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "202228507", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PLUS ANTIMICROBIAL PRODUCT COATING CONTAINS SILVER CARBONATE [APPROXIMATELY 800 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)], AND CHLORHEXIDINE DIACETATE [APPROXIMATELY 1600 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)]. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" THE GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "202228508", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: OPEN SURGERY TO REMOVE THE MESH SECONDARY TO INFECTION. THE MESH WAS FOUND TO BE \"TORN\" AND HAD EXPERIENCED SIGNIFICANT CONTRACTION BASED IN THE 12 X 11 CM EXPLANTED SIZE VS. THE 15 X 19 CM PRE-IMPLANT SIZE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED." }, { "mdr_text_key": "334286914", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSIONS. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. THROUGH GORE'S INVESTIGATION AND BASED ON THE AVAILABLE INFORMATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED. PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE\u00bfS INVESTIGATION. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\u00bf THE INSTRUCTIONS FOR USE FURTHER WARN: \u00bfAS WITH ANY IMPLANTABLE SURGICAL DEVICE, STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\u00bf PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE PERSISTENT/SYMPTOMATIC SEROMA AND WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT\u00bfS UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. C1: THE PLUS ANTIMICROBIAL PRODUCT COATING CONTAINS SILVER CARBONATE [APPROXIMATELY 800 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)], AND CHLORHEXIDINE DIACETATE [APPROXIMATELY 1600 MICROGRAMS PER CUBIC CENTIMETER OF PRODUCT (G/CM3)]. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "321722866", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT PROCEDURE: OPEN COMPLEX HERNIA REPAIR WITH GORE TEX INLAY MESH. IMPLANT: GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL [1DLMCP04/01106603]. IMPLANT DATE: ON (B)(6) 2002 (HOSPITALIZATION ON (B)(6) 2002). [FULL OPERATIVE REPORT NOT PROVIDED IN RECORDS REVIEWED]. ON (B)(6) 2002: (B)(6) HOSPITALS. [SIGNATURE ILLEGIBLE]. BRIEF OPERATIVE NOTE. PRE-OP DIAGNOSIS: VENTRAL HERNIA. POST-OP DIAGNOSIS: [ILLEGIBLE]. RESIDENT SURGEON: (B)(6). TYPE OF ANESTHESIA: GENERAL. FINDINGS: LARGE LOWER MIDLINE VENTRAL HERNIA, ATTENUATED MIDLINE LAP SEAS. SPECIMENS: NONE. DRAINS: 1 JP. ESTIMATED BLOOD LOSS: 50 CC. COMPLICATIONS: NONE. ON (B)(6) 2002: (B)(6) HOSPITALS. IMPLANT STICKER. DUALMESH CORDUROY ANTIMICROBIAL. ITEM#: 1DLMCP04. LOT#: 01106603. THE RECORDS CONFIRM A GORE\u00ae DUALMESH\u00ae PLUS BIOMATERIAL (1DLMCP04/ 01106603) WAS IMPLANTED DURING THE PROCEDURE. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2002: (B)(6), MD. CONSULTATION. HISTORY OF CHRONIC PELVIC PAIN IMPROVED SINCE SURGERY. MAY NEED LONG ACTING OPIATE AT DISCHARGE AND TAPER ON OUTPATIENT BASIS OVER THE NEXT 2-3 WEEKS. ON (B)(6) 2006: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: DIVERTICULITIS, STATUS POST COLOSTOMY. POSTOPERATIVE DIAGNOSIS: DIVERTICULOSIS, STATUS POST COLOSTOMY. PROCEDURE: CYSTOSCOPY AND URETERAL STENT PLACEMENT PRIOR TO COLOSTOMY REVERSAL. ON (B)(6) 2006: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: HISTORY OF COLOSTOMY SECONDARY TO PERFORATED DIVERTICULITIS (HARTMANN PROCEDURE), ATTENTION TO COLOSTOMY. POSTOPERATIVE DIAGNOSIS: HISTORY OF COLOSTOMY SECONDARY TO PERFORATED DIVERTICULITIS (HARTMAN PROCEDURE), ATTENTION TO COLOSTOMY. EXTENSIVE INTRAABDOMINAL ADHESIONS, MORBID OBESITY. PROCEDURE: EXPLORATORY LAPAROTOMY, EXTENSIVE LYSED OF ADHESIONS, MOBILIZATION OF SPLENIC FLEXURE, COLORECTAL ANASTOMOSIS, PARTIAL COLON RESECTION / TAKEDOWN OF HARTMAN\u00bfS PROCEDURE (THE PROCEDURE WAS AN EXTENSIVE PROCEDURE SECONDARY TO PATIENT\u00bfS BODY HABITUS AND PRIOR SURGERY AND THE ENTIRE SURGERY TOOK AT LEAST 2.5 TIMES THE AMOUNT OF TIME THAT SUCH PROCEDURE WOULD NORMALLY TAKE). ON (B)(6) 2006: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: DEEP WOUND INFECTION. POSTOPERATIVE DIAGNOSIS: DEEP WOUND INFECTION. PROCEDURE: DRAINAGE OF DEEP WOUND INFECTION. ANESTHESIA: NONE. COMPLICATIONS: NONE. SPECIMENS: PUS WAS DISCARDED. PACKINGS: CURLEX PACKING. OPERATIVE FINDINGS AND TECHNIQUE: \u00bfWITH VERBAL CONSENT, THE PATIENT WAS SEEN AT THE BEDSIDE IN THREE WEST. STAPLES FROM THE MIDLINE OF THE MIDLINE OF THE ABDOMINAL WOUND WERE REMOVED. THE WOUND WAS PROBED. A LARGE AMOUNT OF FOUL-SMELLING PURULENT MATERIAL WAS EXCRETED. FASCIA WAS PALPATED AND WAS INTACT. THE WOUND WAS PACKED WITH CURLEX AND DRESSINGS WERE APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL.\u00bf EXPLANT PROCEDURE: [EXACT PROCEDURE NAME NOT PROVIDED]. EXPLANT DATE: 2007 [EXACT DATE NOT INDICATED]. [OPERATIVE REPORT NOT PROVIDED IN RECORDS REVIEWED]. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2007: (B)(6), MD. CONSULTATION. HAS HAD SURGERY FOR PERFORATED DIVERTICULITIS WITH COLONOSCOPY AND SUBSEQUENT REVISION. ON (B)(6) OF THIS YEAR, WAS FOUND TO HAVE A LARGE BOWEL OBSTRUCTION AND FOUND TO HAVE A SIGMOID STRICTURE AT (B)(6) HOSPITAL. UNDERWENT SEQUENTIAL DILATATION OF THE STRICTURE AND WAS DOING WELL WITH METAMUCIL AND COLACE WITH REGULAR BOWEL MOVEMENTS. HOWEVER 2 DAYS AGO NOTED A VERY SMALL BOWEL MOVEMENT AND THE ONSET OF ABDOMINAL PAIN. SINCE THAT TIME HAS NOT PASSED FLATUS. ABDOMINAL PAIN INCREASED WITH ASSOCIATED NAUSEA AND VOMITING AND CAME TO THE EMERGENCY DEPARTMENT. HISTORY OF HYPERTENSION; CAESARIAN SECTION TIMES TWO, CHOLECYSTECTOMY, APPENDECTOMY, BLADDER REPAIR, EXCISION OF INFECTED MESH AND DRAINAGE FROM ABDOMINAL WOUNDS. FORMER SMOKER. EXAM: ABDOMEN, REVEALED INCREASED BOWEL SOUNDS, IT WAS SOFT WITH MILD DIFFUSE TENDERNESS WITHOUT REBOUND OR GUARDING. IMPRESSION: LIKELY HAS RECURRENT ANASTOMOTIC STRICTURE. ON (B)(6) 2007: (B)(6), MD. CONSULTATION. HAD PERFORATED DIVERTICULITIS IN 2005. HAD A HARTMANN PROCEDURE WITH DIVERTING COLOSTOMY. EARLY ON (B)(6) 2006 HAD TAKEDOWN OF COLOSTOMY AND DID EXTREMELY WELL. HAD SOME LOW-GRADE FEVERS AND ULTIMATELY WAS READMITTED TO THE HOSPITAL AND IT TURNED OUT SHE HAS SOME FLUID COLLECTIONS IN THE SUBCUTANEOUS AREA CONSISTENT WITH WOUND INFECTIONS WHICH WERE OPENED AND DRAINED. WAS ULTIMATELY DISCHARGE HOME BUT IT BECAME APPARENT FURTHER DURING THE COURSE OF HER WORK UP THAT SHE HAD LIKELY INFECTED A MESH THAT WAS PLACED FOR AN INCISIONAL HERNIA, WHICH WAS DONE AT (B)(6) HILL SEVERAL YEARS AGO. BECAUSE OF THE COMPLEXITY OF THE PROBLEM I CONSULTED DR. (B)(6) AT (B)(6) CENTER, THE PATIENT HAD EXCISION OF HER MESH EARLIER THIS YEAR. HISTORY OF TOTAL ABDOMINAL HYSTERECTOMY; HERNIA REPAIR, IT WAS SUSPECTED INCISIONAL HERNIA WAS FROM CESAREAN SECTIONS; PERFORATED DIVERTICULITIS; HARTMANN PROCEDURE; TAKEDOWN / REVERSAL OF COLOSTOMY; DRAINAGE OF ABDOMINAL WOUND COLLECTIONS; EXCISION OF INFECTED MESH; MORBID OBESITY. EXAM: ABDOMEN, MODERATELY OBESE, MULTIPLE WELL-HEALED INCISIONS. SEVERAL OF THE INTRAABDOMINAL WOUNDS ARE PACKED WITH GAUZE. THERE IS SOME MILD DIFFUSE TENDERNESS BUT NO REBOUND TENDERNESS. CT SCAN DOES REVEAL A LEFT ABDOMINAL WALL HERNIA, LIKELY RELATED TO AN OLD COLOSTOMY SITE. IMPRESSION: DEVELOPING AT LEAST A PARTIAL RESTRUCTURING OF COLORECTAL AREA AGAIN. WILL ALSO LIKELY NEED REPLANTATION OF SYNTHETIC MESH FOR HER INCISIONAL HERNIA AS THE PREVIOUS MESH WAS EXCISED EARLIER THIS MONTH FOR MESH INFECTION. ON (B)(6) 2011: (B)(6), MD. RADIOLOGY-CT ABDOMEN / PELVIS. INDICATION: HERNIA; INCISIONAL VENTRAL WITHOUT OBSTRUCTION / GANGRENE. FINDINGS: PERITONEUM / MESENTERIES: REDOMENSTRATION OF ANTERIOR ABDOMINAL WALL LAXITY. SEGMENTS OF BOTH LARGE AND SMALL BOWEL ARE CLOSELY APPLIED TO THE ANTERIOR ABDOMINAL WALL CONSISTENT WITH THE PRESENCE OF ADHESIONS. MEDIAL TO THE LEFT RECTUS MUSCLE, THERE APPEARS TO BE A MORE LOCALIZED DEFECT, THROUGH WHICH A KNUCKLE OF SMALL BOWEL HERNIATES. GASTROINTESTINAL TRACT: STOMACH AND PROXIMAL SMALL BOWEL WITHIN NORMAL LIMITS. AS NOTED ABOVE, CLOSE APPROXIMATION OF SEGMENTS OF LARGE AND SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL IS CONSISTENT WITH THE PRESENCE OF ADHESIONS. THERE IS SEGMENTAL DILATATION OF SMALL BOWEL LOOPS IN THE LOWER ABDOMEN, LIKELY RELATED TO THE ADHESIVE PROCESS. MUSCULOSKELETAL: INFILTRATION OF THE SUBCUTANEOUS FAT IS AGAIN IDENTIFIED. THERE IS NO LOCALIZED FLUID COLLECTIONS. POSTSURGICAL CHANGES IN THE ABDOMINAL WALL AGAIN SEEN. IMPRESSION: 1) PATIENT VOMITED AFTER RECEIVING THE CONTRAST MATERIAL FOR THIS STUDY, AND ULTIMATELY DEVELOPED HIVES. AS A CONSEQUENCE, THE INITIAL IMAGES ARE COMPROMISED BY MOTION. 2) PATIENT IS STATUS POST COMPLEX SURGICAL RECONSTRUCTION OF THE ANTERIOR ABDOMINAL WALL. THERE IS ABDOMINAL LAXITY EVIDENT ON THIS EXAMINATION. THERE ARE 2 FASCIAL DEFECTS, ONE LOCATED IN THE LEFT SIDE OF THE ABDOMEN MEDIAL TO THE RECTUS MUSCLE, AND ONE LOCATED LOWER ON THE RIGHT HAND SIDE. THESE DEFECTS ARE ASSOCIATED WITH HERNIATION OF SMALL BOWEL LOOPS, BUT THERE IS NO EVIDENCE OF BOWEL OBSTRUCTION OR OTHER COMPLICATIONS IDENTIFIED. 3) INTERVAL RESOLUTION OF FLUID COLLECTION SEEN IN THE ANTERIOR ABDOMINAL WALL ON THE STUDY ON (B)(6) 2010. 4) THERE STILL EVIDENCE OF SOME INFILTRATION OF THE SUBCUTANEOUS FAT, BUT APPEARANCE IS IMPROVED. 5) SEGMENTAL DILATATION OF SMALL BOWEL LOOP IN THE LOWER ABDOMEN. THERE IS CLOSE APPROXIMATION OF SEGMENTS OF LARGE BOWEL TO THE ANTERIOR ABDOMINAL WALL. THESE FINDINGS ARE CONSISTENT WITH INTRA-ABDOMINAL ADHESIONS. 6) HEPATOMEGALY. 7) PATIENT IS STATUS POST CHOLECYSTECTOMY AND HYSTERECTOMY. 8) CHANGES CONSISTENT WITH PARTIAL COLECTOMY. ON (B)(6) 2011: (B)(6), PA-C. OFFICE NOTES. 6 MONTHS OUT FROM OPEN REPAIR OF RECURRENT INCISIONAL HERNIA WITH POSTOPERATIVE COMPLICATED BY A WOUND THAT REQUIRED A WOUND VAC PRESENTS TO THE CLINIC FOR A PREOPERATIVE EVALUATION FOR AN OPEN REPAIR OF A RECURRENT INCISIONAL HERNIA. CT SCAN FOR ABDOMINAL PAIN WHICH REVEALED TWO AREAS IN THE LEFT MID ABDOMEN AND RIGHT LOWER QUADRANT WERE SEEN AS HERNIAS OR LAXITY OF THE BIOLOGIC MESH. HAS AREAS WHERE SHE FEELS BULGE AND HAS PAIN. OVERALL THE EXAM COMPARED WITH PREVIOUS SHOWS RESOLUTION OF SUBCUTANEOUS FLUID AND INFLAMMATORY CHANGES IN THE SUBCUTANEOUS FAT. THE PAIN AND BULGE RESTRICTS HER DESIRED DAILY ACTIVITIES. APPETITE IS NORMAL, NO VOMITING, HAS MILD NAUSEA THAT IS CONTROLLED WITH PHENERGAN. BOWEL HABITS ARE REGULAR AND IS HAVING BOWEL MOVEMENT DAILY. NO RECENT FEVERS, ILLNESSES, CHILLS, COUGH, RASH, OR OTHER SIGNS OF INFECTION. IS HAVING TO TAKE LARGE AMOUNTS OF PAIN MEDICATION TO HELP HER GET THROUGH THE DAY AND WOULD LIKE TO PURSUE SURGICAL INTERVENTION. EXAM: ABDOMEN, SOFT, NON-TENDER, NO MASSES, BOWEL SOUNDS NORMAL. HERNIA, BULGE IN THE LEFT MID ABDOMEN AND THE RIGHT LOWER QUADRANT. ALSO HAS A SMALL CHRONICALLY DRAINING AREA FROM A TRANSFASCIAL SUTURE IN THE LOWER MIDLINE IN THE MONS AREA. IMPRESSION / PLAN: SYMPTOMATIC RECURRENT INCISIONAL HERNIA. DISCUSSED HERNIA AND POSSIBLE TREATMENT OPTIONS AT LENGTH. HAS ELECTED TO HAVE AN OPEN REPAIR OF INCISIONAL HERNIA ON (B)(6) 2011. THE RISKS OF THIS OPERATION WERE EXPLAINED AND SHE VOICES HER UNDERSTANDING OF THESE RISKS. ON (B)(6) 2011: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. PROCEDURES: OPEN INCISIONAL HERNIA REPAIR WITH PLACEMENT OF AN APPROXIMATELY 20X30 CM PIECE OF ULTRAPRO MESH IN A RECTRORECTUS RIVAS-STOPPA FASHION. BILATERAL POSTERIOR FASCIAL RELEASES (MYOFASCIAL ADVANCEMENT FLAP, UNILATERAL). ASSISTANT: (B)(6), MD. DRAINS: A 19-FRENCH ROUND DRAIN INTO THE RECTRORECTUS SPACE. ESTIMATED BLOOD LOSS: 100-200 ML. FLUIDS: CRYSTALLOID AND COLLOID PER THE ANESTHESIA RECORD. COMPLICATIONS: NONE. INDICATIONS: MS. (B)(6) IS A 52-YEAR-OLD FEMALE WELL KNOWN TO ME FROM MULTIPLE HERNIA REPAIRS AND MOST RECENTLY EXCISION OF INFECTED MESH. SHE HAD A BIOLOGIC MESH PLACED AND SUBSEQUENTLY DEVELOPED TWO HERNIAS ALONG HER MIDLINE INCISION. THESE WERE SYMPTOMATIC AND ENLARGING AND SHE PRESENTS FOR REPAIR. TECHNIQUE: \u00bfAFTER INFORMED CONSENT WAS OBTAINED, SHE WAS BROUGHT TO THE OPERATING ROOM, PLACED SUPINE UPON THE OPERATING TABLE. AFTER ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED, SHE WAS PREPPED AND DRAPED IN USUAL STERILE FASHION. A TIME OUT WAS PERFORMED. WE BEGUN BY EXCISING HER PREVIOUS SCAR WITH THE 15 BLADE AND BOVIE CAUTERY. WE DISSECTED DOWN TO SUBCUTANEOUS TISSUE TO THE LEVEL OF THE HERNIA SAC AND ATTENUATED BIOLOGIC MESH. THIS WAS INCISED SHARPLY. THERE WERE ADHESIONS OF THE BOWEL TO THE HERNIA SACS AND INTO THE ANTERIOR ABDOMINAL WALL. THESE WERE VERY GENTLE ADHESIONS WHICH WE TOOK DOWN WITH SHARP DISSECTION AND BLUNT DISSECTION. WE WERE ABLE TO FREE UP THE BOWEL FROM THE ANTERIOR ABDOMINAL WALL CIRCUMFERENTIALLY TO THE LEVEL OF THE PERICOLIC GUTTERS INTO THE PREPUBIC SPACE AND INTO THE EPIGASTRIUM. ONCE WE HAD DONE THIS, WE DISSECTED WHAT APPEARED TO BE THE REMNANT OF HER POSTERIOR FASCIA AND BIOLOGIC MESH OFF THE POSTERIOR MUSCULATURE REMNANTS ON HER RIGHT SIDE. THIS WAS WHERE SHE HAD A LARGE MUSCULAR DEFECT OR MYOFASCIAL DEFECT. WE WERE ABLE TO GET INTO A PLANE THAT INCLUDED HERNIA SAC AND WHAT APPEARED TO POSTERIOR FASCIA AND TOOK THIS OUT TO THE PERICOLIC GUTTER. WE DID EXPOSE THE NEUROVASCULAR BUNDLES OF HER RIGHT RECTUS SHEATH OR THE REMNANT OF HER RIGHT RECTUS SHEATH AND WE WERE ABLE TO DISSECT A PREPERITONEAL PLANE TO THE PERICOLIC GUTTER. ON THE LEFT SIDE, HER RECTUS SHEATH MUSCLE WAS INTACT AND HER POSTERIOR SHEATH WAS INTACT AND WE DISSECTED THROUGH THIS WITH BOVIE CAUTERY AND BLUNT DISSECTION TO THE LATERAL EDGE OF THE RECTUS SHEATH ON THE RIGHT. INFERIORLY, WE DISSECTED THE PREPERITONEAL PLANE TO THE PREPUBIC SPACE AND SOMEWHAT LATERALLY TO THE PERICOLIC GUTTER ON THE LEFT AS WELL. WE THEN CLOSED THIS PREPERITONEAL LAYER OF FASCIA, OLD HERNIA SAC AND ATTENUATED BIOLOGIC MESH WITH RUNNING 0 PDS. WE IRRIGATED THIS SPACE. WE THEN TOOK A 30X30 CM AND ROUNDED OFF THE CORNERS INFERIORLY AND SUPERIORLY. IT WAS PLACED INTO THE PREPERITONEAL SPACE BEHIND THE RECTUS MUSCULATURE ON THE LEFT AND BEHIND THE REMNANTS OF THE RECTUS MUSCULATURE AND THE OBLIQUE MUSCULATURE ON THE RIGHT. IT WAS SECURED WITH ONE TRANSFASCIAL STITCH INFERIORLY, TWO TRANSFASCIAL STITCHES SUPERIORLY, TWO TRANSFACIAL SUTURES ON THE RIGHT SIDE IN THE RIGHT LOWER QUADRANT AND RIGHT MID ABDOMEN AND ONE LEFT-SIDED MIDABDOMINAL TRANSFACIAL STITCH. THESE WERE 0 ETHIBOND SUTURES AND THEY WERE PASSED TRANSFASCIALLY WITH THE USE OF THE REVERTED NEEDLE. WE WERE THEN ABLE TO CLOSE THE ANTERIOR FASCIA ON THE LEFT AND THE ANTERIOR FASCIA AND SCAR ON THE RIGHT TO COVER THE MESH. PRIOR TO DOING SO, WE PLACED A 19-FRENCH ROUND DRAIN THROUGH THE RIGHT LOWER QUADRANT STAB INCISION WE MADE FOR THE PASSAGE OF THE TRANSFASCIAL SUTURE. THIS WAS SECURED WITH A 2-0 NYLON STITCH. THE FASCIA AGAIN WAS CLOSED WITH A RUNNING #1 LOOPED PDS. SUBCUTANEOUS TISSUE WAS IRRIGATED. THE SKIN WAS APPROXIMATED WITH SKIN STAPLER. AN INCISIONAL VAC WAS PLACED. THE PATIENT WAS AWAKENED, EXTUBATED AND TAKEN TO RECOVERY ROOM HAVING TOLERATED THE PROCEDURE WELL. ON (B)(6) 2011: (B)(6) CENTER. IMPLANT RECORD. ETHICON ULTRAPRO MESH. ON (B)(6) 2011: (B)(6), MD. DISCHARGE SUMMARY. DISCHARGE DIAGNOSIS: MIDLINE INCISIONAL HERNIA. HISTORY OF PRESENT ILLNESS: KNOWN TO HAVE MULTIPLE HERNIAS AND MOST RECENTLY HAD EXCISION OF INFECTED MESH. HAD AT THAT TIME BIOLOGIC MESH PLACED AND SUBSEQUENTLY DEVELOPED TWO HERNIAS ALONG MIDLINE INCISION. THERE ARE SYMPTOMATIC AND ENLARGING, PRESENTS FOR REPAIR. HOSPITAL COURSE: TOLERATED PROCEDURE WELL AND WAS TRANSFERRED TO THE FLOOR IN STABLE CONDITION. ON POSTOPERATIVE DAY ONE, LEFT NOTHING BY MOUTH WITH NASOGASTRIC TUBE IN PLACE. WHEN SHE BEGAN TO HAVE DECREASED OUTPUT RANGING IN PASS FLATUS ON POSTOPERATIVE DAY TWO, THE NASOGASTRIC TUBE WAS REMOVED. WAS THEN STARTED ON A CLEAR LIQUID DIET, WHICH WAS TOLERATED WELL. THEN STARTED ON HOME NARCOTICS REGIMEN. WAS SLOWLY ADVANCING DIET AND BY DISCHARGE WAS TOLERATING REGULAR DIET. WAS AMBULATING WITHOUT DIFFICULTY, PAIN WAS CONTROLLED ON ORAL PAIN MEDS, WAS TOLERATING A REGULAR DIET, GOOD URINE OUTPUT, NORMAL BOWEL FUNCTION. EXAM: ABDOMEN, SOFT, APPROPRIATELY TENDER AROUND MIDLINE INCISION, NONDISTENDED, POSITIVE BOWEL SOUNDS. WOUNDS, MIDLINE INCISION IS CLEAN, DRY AND INTACT. INSTRUCTIONS: TO RESUME NORMAL ACTIVITY, BUT IS TO AVOID STRENUOUS ACTIVITIES SUCH AS LIFTING MORE THAN 10 POUNDS OR DOING STRENUOUS EXERCISE FOR AT LEAST ON MONTH. ON (B)(6) 2011: (B)(6), PA-C. OFFICE NOTES. 2 MONTHS OUT FROM AN OPEN INCISIONAL HERNIA REPAIR WITH A RETRORECTUS MESH WITH POST OPERATIVE DRAINING FISTULA AT INCISION. HAS REPORTED LOW GRADE FEVERS AND CHILLS. DRAINAGE THROUGHOUT THE DAY. PAIN AT SITES OF DRAINAGE. NO OTHER TENDERNESS. NO BULGE AT SITE OF PREVIOUS REPAIR. OTHER THAN DRAINAGE, IS FEELING WELL AND HAS NO CONCERNS. EXAM: ABDOMEN, SOFT, NON-TENDER, NO MASSES, BOWEL SOUNDS NORMAL. OPEN DRAINAGE SINUS AT INFERIOR MARGIN OF MIDLINE INCISION. OPEN DRAINING SINUS LEFT OF MIDLINE. DRAINAGE WITH FOUL ODOR. HERNIA, NO HERNIAS. IMPRESSION / PLAN: ABDOMINAL FISTULAS STATUS POST OPEN HERNIA REPAIR. DISCUSSED SYMPTOMS AND DRAINAGE AT LENGTH. HAS ELECTED TO HAVE AN ABDOMINAL WALL EXPLORATION ON (B)(6) 2011. THE RISKS OF THE OPERATION WERE EXPLAINED AND SHE VOICES UNDERSTANDING OF THESE RISKS. ON (B)(6) 2011: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: SUTURE ABSCESS LEFT ABDOMINAL WALL, CHRONIC DRAINING SINUS, LOWER MIDLINE. POSTOPERATIVE DIAGNOSIS: SUTURE ABSCESS LEFT ABDOMINAL WALL, CHRONIC DRAINING SINUS, LOWER MIDLINE WITH THE LOWER MIDLINE BEING A CHRONIC SEROMA DRAINAGE. PROCEDURE: ABDOMINAL WALL EXPLORATION AND REMOVAL OF INFECTED SUTURE AND DRAINAGE AND DEBRIDEMENT OF ABDOMINAL WALL SEROMA. ASSISTANT: (B)(6), MD. ANESTHESIA: GENERAL ENDOTRACHEAL ANESTHESIA ALONG WITH LOCAL. ESTIMATED BLOOD LOSS: MINIMAL. FLUIDS: CRYSTALLOIDS. SPECIMENS: CULTURES OF BOTH WOUNDS. INDICATIONS: MS. (B)(6) IS A 52-YEAR-OLD FEMALE KNOWN TO ME FOR MULTIPLE ABDOMINAL WALL SURGERIES. AFTER THE LAST HOPEFULLY DEFINITIVE SURGERY, SHE HAS DEVELOPED A PURULENT DRAINAGE FROM A TRANSFASCIAL SUTURE SITE IN THE LEFT MID ABDOMINAL WALL, SINCE IT IS AN INTERMITTENTLY INTERRUPTED LOW MIDLINE WOUND, BOTH ARE FOR EXPLORATION TODAY. TECHNIQUE: \u00bfAFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS MARKED IN THE PREOPERATIVE BACK TO THE OPERATING ROOM AND PLACED SUPINE UPON THE OPERATING TABLE. AFTER ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED, SHE WAS PREPPED AND DRAPED IN USUAL STERILE FASHION. WE STARTED IN THE MIDLINE, THERE WAS A WOUND APPROXIMATELY 2-3 CM IN WIDTH WITH A CHRONIC GRANULATION TISSUE AND THIS WAS BLUNTLY DISSECTED AND OPENED UP SLIGHTLY MORE WITH BOVIE CAUTERY. WE DISSECTED DOWN TO THE STOMACH CAVITY, WHICH HAD BEEN APPEARING DRAINAGE AND TISSUE CONSISTENT WITH SEROMA CAVITY. THIS WAS DEBRIDED USING LAP PADS AND SHARP DEBRIDEMENT WITH BOVIE CAUTERY. THE CAVITY DID ANY BLEED ANY PERMANENT SUTURE, WE FOUND SOME ABSORBABLE SUTURE AND CUT IT. IT WAS THEN IRRIGATED WITH BACITRACIN IRRIGATION AND PACKED WITH 2 INCH KLING GAUZE SOAKED IN 0.25% DAKIN SOLUTION. WE ANESTHETIZED THE SKIN AROUND THE LEFT MID ABDOMINAL DRAIN SITE. THIS WAS OPENED WITH THE KNIFE AND FURTHER DISSECTED WITH BOVIE CAUTERY. WE DISSECTED THE TRACT DOWN TO ITS BASE AND THEN AMPUTATED SINUS TRACT EXERCISING IT TOTALLY. AT THE BASE, WE FOUND A 0 ETHIBOND SUTURE, WHICH WAS CUT AND REMOVED. THE BASE IF THE SINUS TRACT WAS CAUTERIZED. IT WAS PACKED WITH 2 INCH KLING GAUZE AND 0.25% DAKIN SOLUTION. DRESSINGS WERE PLACED. THE PATIENT WAS THEN AWAKENED, EXTUBATED AND TAKEN TO RECOVERY ROOM HAVING TOLERATED PROCEDURE WELL. ON (B)(6) 2011: (B)(6), MD. DISCHARGE SUMMARY. ADMISSION DIAGNOSIS: ABDOMINAL FISTULA STATUS POST OPEN HERNIA REPAIR. DISCHARGE DIAGNOSIS: SUTURE ABSCESS OF LEFT ABDOMINAL WALL; CHRONIC DRAINING SINUS IN THE LEFT LOWER MIDLINE WITH CHRONIC SEROMA. TAKEN TO THE OPERATING ROOM WHERE IT WAS DISCOVERED THAT IN HER LEFT ABDOMINAL WALL, SHE HAD A STITCH ABSCESS. THE STITCH WAS REMOVED AND THE AREA WAS WASHED OUT AND PACKED WITH DAKIN-SOAKED GAUZE. IN LOWER MIDLINE INCISION, WAS FOUND TO A HAVE A SINUS TRACT TRACKING UP TO AN ABDOMINAL WALL SEROMA. THE TRACT WAS INTERMITTENTLY DRAINING THROUGH THE MIDLINE WOUND. THIS WAS WASHED OUT AS WELL AND PACKED WITH DAKIN SOLUTION-SOAKED GAUZE. TOLERATED PROCEDURE WELL AND WAS TAKEN POSTOPERATIVELY TO THE DAY HOSPITAL. OVERNIGHT, DID WELL. TOLERATING REGULAR DIET, AMBULATING WITHOUT DIFFICULTY AND PAIN WAS WELL CONTROLLED ON ORAL PAIN MEDICATIONS. WAS TAUGHT HOW TO PERFORM WET-TO-DRY DRESSING CHANGES WITH THE DAKIN SOLUTION \u00bf SOAKED GAUZE ON HER TWO OPEN WOUNDS. VOICED UNDERSTANDING. ACTIVITY: UP AS TOLERATED. DO NOT LIFT GREATER THAN 10 POUNDS FOR 1 WEEK. ON (B)(6) 2011: (B)(6), MD. RADIOLOGY-CT ABDOMEN / PELVIS. INDICATION: EVALUATION FOR ABSCESS. FINDINGS: GASTROINTESTINAL TRACT: MULTIPLE LOOPS OF SMALL BOWEL AS WELL AS THE TRANSVERSE COLON ARE CLOSELY APPOSED TO THE VENTRAL ABDOMINAL WALL, CONSISTENT WITH ADHESIVE CHANGES. MUSCULATURE: STATUS POST REVISION OF THE COMPLEX SURGICAL RECONSTRUCTION OF THE VENTRAL WALL WITH MINIMAL RESIDUAL MIDLINE ABDOMINAL LAXITY. A SMALL AMOUNT OF SOFT TISSUE STRANDING IS PRESENT ALONG THE MIDLINE INCISION SITE. INTERVAL DEVELOPMENT OF A NEW LARGE FOCAL HERNIA ALONG THE LATERAL MARGIN OF THE LEFT RECTUS MUSCLE WHICH CONTAINS LOOPS OF SMALL BOWEL WITHOUT EVIDENCE OF OBSTRUCTION. NEW FISTULOUS TRACT WITHIN THE LEFT LATERAL VENTRAL ABDOMINAL WALL INFERIOR TO THE HERNIA WITH SEVERAL SMALL BOWEL LOOPS IN CLOSE ASSOCIATION WITH THE TRACT, BUT IT CANNOT BE DETERMINED ON CT WHETHER THERE IS A DEFINITE COMMUNICATION. HOWEVER, THERE ARE NO ADJACENT FLUID COLLECTIONS SUGGESTIVE OF AN ABSCESS. QUESTION OF AN ADDITIONAL SINUS TRACT WITH SOFT TISSUE THICKENING INFERIOR TO THE SYMPHYSIS PUBIS WHICH CONTAINS SUTURE MATERIAL AN IS SLIGHTLY INCREASED IN SIZE COMPARED TO ON (B)(6) 2011. IMPRESSION: 1) STATUS POST INTERVAL REVISION OF THE COMPLEX SURGICAL RECONSTRUCTION OF THE VENTRAL ABDOMINAL WALL WITH MINIMAL RESIDUAL MIDLINE ABDOMINAL LAXITY. THERE HAS BEEN INTERVAL DEVELOPMENT OF A NEW LARGE FOCAL HERNIA ALONG THE LATERAL MARGIN OF THE LEFT RECTUS MUSCLE WHICH CONTAINS LOOPS OF SMALL BOWEL WITHOUT EVIDENCE OF OBSTRUCTION. A NEW FISTULOUS TRACT ALSO PRESENTS WITHIN THE LEFT LATERAL VENTRAL ABDOMINAL WALL WITH SEVERAL SMALL LOOPS IN CLOSE ASSOCIATION WITH THE TRACT, BUT IT CANNOT BE DETERMINED ON CT WHETHER THERE IS A DEFINITE COMMUNICATION. HOWEVER, THERE ARE NO ASSOCIATED ADJACENT FLUID COLLECTIONS SUGGESTIVE OF AN ABSCESS. ADDITIONALLY, THERE IS QUESTION OF AN ADDITIONAL SINUS TRACT INFERIOR TO THE SYMPHYSIS PUBIS WHICH CONTAINS SUTURE MATERIAL AND IS SLIGHTLY INCREASED IN SIZE COMPARED TO ON (B)(6) 2011. 2) MULTIPLE LOOPS OF SMALL BOWEL AS WELL AS THE TRANSVERSE COLON ARE CLOSELY APPOSED TO THE VENTRAL ABDOMINAL WALL, CONSISTENT WITH ADHESIVE CHANGES. HOWEVER, THERE IS NO EVIDENCE OF BOWEL OBSTRUCTION. 3). STATUS POST COLECTOMY. 4) HEPATOMEGALY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3750 W. 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(B)(6), MD. OPERATIVE REPORT. [OPERATIVE REPORT START ON PAGE 2, PAGE ONE IS MISSING]. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. PROCEDURE: EXPLORATORY LAPAROTOMY. EXTENSIVE LYSIS OF ADHESIONS, 1 HOUR. REPAIR OF RECURRENT INCISIONAL HERNIA 10 X 10 CM WITH SURGISIS MESH. EXCISION AND DEBRIDEMENT OF INFECTED SKIN. PARTIAL OMENTECTOMY. ANESTHESIA: GENERAL. SPECIMEN: PORTION OF OMENTUM. COMPLICATIONS: NONE. CONDITION: STABLE. EXTUBATED AND TRANSFERRED TO PACU. INDICATION: 55-YEAR-OLD FEMALE WHO PRESENTED TO THE GENERAL SURGERY CLINIC ON (B)(6) 2009, WITH RECURRENT VENTRAL HERNIA 2 MONTHS AFTER REPAIR. THE PATIENT WAS ASSESSED AND WAS NOT FOUND TO HAVE ANY SYMPTOMS OR SIGNS OF INCARCERATION OR STRANGULATION. SHE WAS COMPLAINING OF PAIN AND DISCOMFORT FROM THE HERNIA AND WAS SCHEDULED FOR RECURRENT INCISIONAL HERNIA REPAIR. DESCRIPTION OF PROCEDURE: \u00bfAFTER OBTAINING INFORMED CONSENT, THE PATIENT WAS TAKEN TO THE OR, PLACED ON THE BED IN SUPINE POSITION AND WAS PREPPED AND DRAPED IN THE GENERAL SURGICAL FASHION. GENERAL ANESTHESIA WAS INDUCED. A MIDLINE LAPAROTOMY WAS DONE OVER THE HERNIA SITE USING A 10 BLADE SCALPEL. THE ABDOMINAL CAVITY WAS SAFELY ENTERED CEPHALAD TO THE HERNIA AND THEN LYSIS OF ADHESIONS WAS DONE ALONG THE MIDLINE UNTIL THE WHOLE INCISION WAS OPEN. THE HERNIA WAS IDENTIFIED AND WAS FOUND TO BE ABOUT 10 X 10 CM. THERE WERE FOUND TO BE EXTENSIVE ADHESIONS BETWEEN THE OMENTUM AND THE ABDOMINAL WALL AND THIS WAS TAKEN DOWN USING ELECTROCAUTERY AWAY FROM THE BOWEL. THERE WAS FOUND TO BE ADHESIONS BETWEEN THE SMALL BOWEL AND THE ABDOMINAL WALL, AND THESE WERE TAKEN DOWN USING SHARP DISSECTION WITH SCISSORS AS WELL AS DIGITAL BLUNT DISSECTION. LYSIS OF ADHESIONS LASTED FOR ABOUT 1 HOUR. AFTER LYSIS OF ADHESIONS WAS PERFORMED AND THE FASCIAL EDGES WERE FREED, THE HERNIA MEASURED ABOUT 10 X 10 CM. WE PROCEEDED WITH AN UNDERLYING REPAIR OF THE HERNIA USING SURGISIS MESH OBTAINING 4-CM CIRCUMFERENTIALLY OF MARGIN UNDER THE FASCIA. SURGISIS MESH WAS USED BECAUSE THE PATIENT HAD EVIDENCE OF A SKIN INFECTION AT THE SCAR AND THINNING OF THE SKIN IN THIS AREA. THE SURGISIS MESH WAS SECURED USING 0 VICRYL SUTURE IN INTERRUPTED FASHION. AFTER THE MESH WAS PLACED, THE WOUND WAS IRRIGATED AND THE INFECTED PORTION OF THE SKIN WAS DEBRIDED USING ELECTROCAUTERY AS WELL AS UNDERLYING SUBCUTANEOUS TISSUE AND SEND TO PATHOLOGY AS A SPECIMEN. THERE ARE NUMEROUS ADHESIONS. A PARTIAL OMENTECTOMY WAS DONE AS THERE WERE MULTIPLE DEFECTS IN THE OMENTUM AND THIS WAS DONE TO AVOID INTERNAL HERNIA. THE SKIN WAS THEN CLOSED USING 2-0 NYLON SUTURE IN INTERRUPTED VERTICAL MATTRESS FASHION. THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS OCCURRED. I WAS THE ATTENDING SURGEON AND WAS PRESENT AND SCRUBBED FOR THE ENTIRE PROCEDURE AND PERFORMED THE ENTIRE OPERATION. THERE WAS NO RESIDENT SCRUBBING ON THE PROCEDURE.\u00bf ON (B)(6) 2009: (B)(6) HOSPITAL. IMPLANT RECORD. IMPLANT: BIODESIGN, SURGISYS GOLD. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2012: (B)(6) CENTER FOR WEIGHT MANAGEMENT & SURGICAL SERVICES. (B)(6), MD, FACS, FASMBS. OFFICE NOTES. PRESENTS TODAY WITH 3 MONTH HISTORY OF ABDOMINAL PAIN. FATIGUE, FEVER, CHILLS, WAS TOLD SHE HAD A SEROMA. WEIGHT 134 LB. EXAM: ABDOMEN WITH MILD DIFFUSE TENDERNESS, NO PERITONEAL SIGN. IMPRESSION: I REVIEWED THE FILMS AND THE CT AND ULTRASOUND REPORTS AND THE PICTURE IS SUSPICIOUS OF MESH INFECTION. PLAN: SCHEDULE FOR EXPLORATORY LAPAROTOMY, MESH REMOVAL AND HERNIA REPAIR WITH ABSORBABLE MESH. I DISCUSSED THE FINDINGS AND PROCEDURE WITH THE PATIENT AND HUSBAND IN DETAILS INCLUDING RISKS AND BENEFITS AND COMPLICATIONS SUCH AS BLEEDING, INFECTION, DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM, DEATH, HEART ATTACK, STROKE AND ANESTHESIA COMPLICATIONS. WE DISCUSSED COMPLICATIONS AS HERNIA RECURRENCE, BOWEL INJURY, CHRONIC PAIN. PATIENT UNDERSTANDS THE RISKS AND BENEFITS OF SURGERY AND WISHES TO PROCEED WITH THE OPERATION. ON (B)(6) 2013: (B)(6) HOSPITAL. [SIGNATURE ILLEGIBLE]. ANESTHESIA RECORD. WEIGHT 130 LB. ASA 3. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2013: (B)(6) HOSPITAL. LAB. ABDOMINAL FLUID- RARE GROWTH, GRAM POSITIVE COCCI. ABDOMINAL MESH- RARE GROWTH, STAPHYLOCOCCUS AUREUS. ON (B)(6) 2013: (B)(6) HOSPITAL. [LAST NAME ILLEGIBLE]. ANESTHESIA RECORD. WEIGHT 134 LB. ASA 3. EXPLANT #1 DATE: (B)(6) 2013 (HOSPITALIZATION FROM (B)(6) 2013) RELEVANT MEDICAL INFORMATION: ON (B)(6) 2013: (B)(6) HOSPITAL. LAB. GLUCOSE 132 H (74-106), WBC 15.3 H (3.8-11.8). ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), MD, FACS, FASMBS. DISCHARGE SUMMARY. ADMITTED: ON (B)(6) 2013. PRINCIPAL DIAGNOSIS ON ADMISSION: ABDOMINAL PAIN, INFECTED MESH. DIET AS TOLERATED. NO LIFTING MORE THAN 15 LBS. KEEP WOUND CLEAN, SHOWER, AVOID SCRUBBING OR SUBMERGING OF THE WOUND. HOSPITAL COURSE: HISTORY ON HERNIA REPAIRED DEVELOPED MESH INFECTION, ATTEMPT TO SALVAGE THE MESH WAS NOT SUCCESSFUL AND WAS SUBSEQUENTLY SCHEDULED FOR REMOVAL OF MESH. POST-OPERATIVELY THE PATIENT IS DOING WELL, WOUND WAS LEFT OPEN FOR PRIMARY CLOSURE. IODOFORM PACKING WAS REMOVED FROM WOUND ON POST-OPERATIVE DAY ONE AND THEN WET TO DRY DRESSINGS TWICE A DAY WAS DONE AND WOUND WAS CLOSED BY THE DAY OF PRIMARY CLOSURE ON (B)(6) 2013, DISCHARGED HOME TODAY AND FOLLOW-UP IN TWO WEEKS AND SHE WILL FOLLOW-UP WITH DR. (B)(6) IN OFFICE. ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), CRNA. ANESTHESIA RECORD. WEIGHT 152 LB. ASA 3. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2013: (B)(6) HOSPITAL. C. STUMP, RN. NURSE NOTES. NO COMPLAINT OF PAIN. PORT SITES X 5 WELL APPROXIMATED. NO DRAINAGE NOTED FROM PORT SITES. ABDOMINAL BINDER CLEAN AND DRY. ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), MD, FACS, FASMBS. DISCHARGE SUMMARY. ADMITTED ON (B)(6) 2013. DIAGNOSIS ON ADMISSION: RECURRENT INCISIONAL HERNIA. DIET AS TOLERATED. NO LIFTING MORE THAN 15 LBS THE FIRST TWO WEEKS. KEEP WOUNDS CLEAN, SHOWER, AVOID SCRUBBING OR SUBMERGING OF THE WOUNDS. HOSPITAL COURSE: PROCEDURE WAS UNEVENTFUL. PATIENT STARTED ON LIQUID DIET WHICH SHE TOLERATED. SHE WAS AMBULATING. INITIALLY HAD URINARY RETENTION AND WAS STRAIGHT CATHED ONCE AND SUBSEQUENTLY THIS RESOLVED. DISCHARGED HOME IN STABLE CONDITION AND WILL FOLLOW-UP IN OFFICE. ON (B)(6) 2015. (B)(6) HOSPITAL. (B)(6), MD, FACS, FASMBS. CONSULTATION. AT (B)(6) HOSPITAL EMERGENCY ROOM YESTERDAY WAS DIAGNOSED WITH FLUID COLLECTION AROUND THE MESH THAT WAS PLACED IN 2013. THE HOSPITAL CONTACTED US AND REQUESTED TRANSFER. SURGEON THERE STATED HE WAS NOT COMFORTABLE DEALING WITH HER CASE. PATIENT STATED PROBLEM STARTED FOUR WEEKS AGO WITH INTERMITTENT DRAINAGE PROGRESSIVELY WORSENING. HAD MUCOPURULENT DISCHARGE; CHILLS, DULL ABDOMINAL PAIN IN SUPRAUMBILICAL AREA. ADMITTED WITH NO NEW COMPLAINTS. EXAM: ABDOMEN SOFT, NON-DISTENDED. HAS A SINUS IN THE SUPRAUMBILICAL AREA WITH ERYTHEMA AND MILD INDURATION. IMAGING: I REVIEWED THE CT SCAN DONE AT CAMDEN-CLARK. THERE IS A SUPRA-AND INFRA-MESH COLLECTION. IMPRESSION/PLAN: INTRAABDOMINAL FLUID COLLECTION; MESH INFECTION WITH RECURRENT SINUS DRAINAGE. CONTINUE LINEZOLID AND PAIN CONTROL. TAKE THE PATIENT TO OPERATING ROOM TODAY. I GAVE HER THE OPTION OF TRYING TO SALVAGE THE MESH BY DRAINAGE, DRAINING THE INFECTION AND LEAVE THE WOUND OPEN WITH PLACEMENT OF VAC DRESSING AND CONTINUING ANTIBIOTIC. THE OTHER OPTION IS TO GO IN AND COMPLETELY REMOVE THE MESH AND REPAIR WITH A BIOLOGIC MESH. I DISCUSSED THE RISK AND THE BENEFITS OF BOTH APPROACHES. I BELIEVE IT IS REASONABLE TO TRY TO SALVAGE THE MESH IF POSSIBLE AND THE PATIENT IS AGREEABLE TO THE PLAN. SHE UNDERSTANDS THERE IS A CHANGE THAT WE MIGHT NEED TO REMOVE THE MESH EVENTUALLY. I DISCUSSED THE RISK AND BENEFITS, INCLUDING BLEEDING, INFECTION HERNIA, CHRONIC PAIN, CHRONIC SINUSES, FISTULA, BOWEL INJURY, AND NEED FOR ADDITIONAL PROCEDURES. THE PATIENT UNDERSTANDS THE RISKS AND BENEFITS AND CONSENTS TO THE PROCEDURE WITH SURGERY. ON (B)(6) 2015. (B)(6) HOSPITAL. (B)(6) , MD. HISTORY AND PHYSICAL. CURRENTLY HAVING COMPLAINTS OF DISCHARGE AT SURGERY SITE. SHE IS FEELING COMFORTABLE OVERALL. HISTORY OF HYPERTENSION, GASTROESOPHAGEAL REFLUX DISEASE, IRRITABLE BOWEL SYNDROME, DEPRESSION, MYOCARDIAL INFARCTION IN 2000. MEDICATIONS INCLUDE ASPIRIN. EXAM: ABDOMEN SOFT, NON-DISTENDED. BOWEL SOUNDS ARE AUDIBLE. SURGERY SITE SHOWS MILD COLLECTION AND MILD TENDERNESS. ON (B)(6) 2015: (B)(6) HOSPITAL. [SIGNATURE ILLEGIBLE]. ANESTHESIA RECORD. WEIGHT 65-77 KG, BMI 26.5. DIABETES. ASA 3E. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2015: (B)(6) HOSPITAL. LAB. ABDOMEN- STAPHYLOCOCCI AUREUS. ON (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) , MD. DISCHARGE SUMMARY. ADMITTED: ON (B)(6) 2015. DISCHARGE DIAGNOSIS: SURGICAL WOUND INFECTION SEQUELAE. ESSENTIAL HYPERTENSION. STABLE CORONARY ARTERY DISEASE. HISTORY OF DEPRESSION. HOSPITAL COURSE: ADMITTED SUBSEQUENT TO COMPLAINT OF DISCHARGE AT HER VENTRAL HERNIA REPAIR SURGERY SITE. DR. (B)(6) PUT A JACKSON-PRATT DRAIN IN THE WOUND AND DRAINED THE SUBCUTANEOUS FLUID COLLECTION AT THE SURGERY SITE. THE PLAN IS TO GET HER A WOUND VAC PLACED. DISCHARGING HER TODAY WITH A COURSE OF ANTIBIOTICS FOR SEVEN DAYS. SURGERY RELATED CARE SHOULD BE FOLLOWED UP WITH DR. (B)(6). SEE PRIMARY CARE PHYSICIAN AS SCHEDULED. ON (B)(6) 2016: (B)(6) HOSPITAL. [SIGNATURE ILLEGIBLE]. ANESTHESIA RECORDS. WEIGHT 135 LB, BMI 25.4. ON (B)(6) 2016: (B)(6) . (B)(6) . PATHOLOGY. FINAL DIAGNOSIS: \u00bfABSCESS CAVITY. FIBROADIPOSE TISSUE SHOWING HEMORRHAGE, NECROSIS AND ABSCESS FORMATION. PAS FUNGAL STAIN IS NEGATIVE.\u00bf RELATED MEDICAL DATA: MESH INFECTION. SPECIMEN INFORMATION: ABSCESS CAVITY. GROSS DESCRIPTION: THE SPECIMEN IS LABELED ABSCESS CAVITY. RECEIVED IS AN AGGREGATE OF GRAY-TAN SOFT PERITONEAL TISSUE AND YELLOW ADIPOSE. SPECIMEN MEASURES 6.5 X 5.0 X 1.7 CM. THIS TISSUE IS RAGGED AND ROUGHENED. THERE ARE AREA OF QUESTIONABLE VIABILITY. NO FOCAL LESION IS OBSERVED. AREAS OF THE TISSUE ARE HEMORRHAGIC. CUT SURFACE IS TAN-WHITE AND SMOOTH. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2016: (B)(6) HOSPITAL. LAB. ABDOMINAL MESH- PROTEUS MIRABILIS, STREPTOCOCCUS AGALACTIAE, ENTEROCOCCUS FAECALIS. 6/28/2016: (B)(6) HOSPITAL. (B)(6), MD. CONSULTATION. MANAGEMENT OF CORONARY ARTERY DISEASE AS WELL AS WOUND INFECTION. WHITE CELL COUNT 18.6. SHE DOES NOT SMOKE. IMPRESSION/PLAN: CORONARY ARTERY DISEASE POST BYPASS 8-YEARS AGO. RESTART ASPIRIN. GASTROESOPHAGEAL REFLUX DISEASE, STABLE. ON PROTONIX. HYPERTENSION; CONTINUE LOPRESSOR. HISTORY OF RECENT INFECTION, START ON VANCOMYCIN. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), MD, FACS, FASMBS. PROGRESS NOTES. DOING WELL, AMBULATING, TOLERATING LIQUIDS. EXAM: ABDOMEN SOFT, NON-TENDER, NON-DISTENDED. DRESSING CHANGE TODAY. WOUND LOOKS CLEAN. IRRIGATED WITH HYDROGEN PEROXIDE AFTER FOAM PACK WAS REMOVED AND WET TO DRY DRESSING WAS APPLIED. PLAN IS PRIMARY CLOSURE, HYPOMAGNESIUM REPLACED. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), MD, FACS, FASMBS. PROGRESS NOTES. DOING WELL, NO COMPLAINTS. EXAM: ABDOMEN SOFT, NON-TENDER, NON-DISTENDED. I CLOSED WOUND TODAY AT BEDSIDE. IMPRESSION/PLAN: WOUND LOOKS EXCELLENT TODAY; NO EVIDENCE OF INFECTION. WOUND AS IRRIGATED WITH BETADINE AND PREVIOUSLY TAKEN AND LEFT UNTIED VERTICAL MATTRESS SUTURES WERE TIED AT BEDSIDE AND STERILE DRESSING WAS APPLIED. TOLERATED PROCEDURE WELL. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), MD. PROGRESS NOTES. EXAM: ABDOMEN WITH CENTRAL DRESSING IN PLACE. MILD TENDERNESS. IMPRESSION/PLAN: WOUND INFECTION WITH GRAM NEGATIVE, GROWING POSSIBLE PSEUDOMONAS. CONTINUE ZOSYN, VANCOMYCIN. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6), MD. DISCHARGE SUMMARY. DATE OF ADMISSION: ON (B)(6) 2016. DISCHARGE DIAGNOSIS: CHRONIC ABDOMINAL WOUND WITH A MESH INVOLVEMENT, STATUS POST HIATAL HERNIA REPAIR AS WELL AS EXPLORATORY LAPAROTOMY. CULTURE IS PROTEUS, WHICH IS EXTENDED-SPECTRUM BETA-LACTAMASES. COURSE OF HOSPITAL: ADMITTED AND OPERATED BY DR. (B)(6) FOR INFECTED MESH AND A HERNIA REPAIR. THE PROCEDURE WENT WELL. WE INITIALLY STARTED HER ON ANTIBIOTICS. CULTURE CAME BACK AS PROTEUS, WHICH IS EXTENDED-SPECTRUM BETA-LACTAMASES SO WE ARE MAKING PLANS FOR HOME HEALTH TO HAVE HER GO THERE TO HER HOUSE AND GIVE ANTIBIOTICS. FOLLOW UP WITH DR. (B)(6). EXAM: ABDOMEN SOFT, NON-TENDER. NO MASSES. BOWEL SOUNDS PRESENT. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. IT SHOULD BE NOTED THAT THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL." }, { "mdr_text_key": "319508025", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: CONCLUSION CODE REMAINS UNCHANGED. G4/G5: ADDED 510/PMK #." }, { "mdr_text_key": "333462716", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED HEALTH EFFECT H6: UPDATED INVESTIGATION FINDING H6: UPDATED INVESTIGATION CONCLUSIONS THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. IT SHOULD BE NOTED THAT THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\u00bf THE INSTRUCTIONS FOR USE FURTHER WARN: \u00bfAS WITH ANY IMPLANTABLE SURGICAL DEVICE, STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\u00bf \u00bfWHEN USING THIS DEVICE AS A PERMANENT IMPLANT AND EXPOSURE OCCURS, TREAT TO AVOID CONTAMINATION, OR DEVICE REMOVAL MAY BE NECESSARY.\u00bf PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE PERSISTENT/SYMPTOMATIC SEROMA AND WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE \u00bfD15: CAUSE NOT ESTABLISHED\u00bf IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT\u00bfS UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "202515347", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT SHOULD BE NOTED THAT THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "202515348", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE-TEX\u00ae SOFT TISSUE PATCH, AND ON (B)(6) 2013 WHEREBY A GORE\u00ae DUALMESH\u00ae BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, (B)(6) 2013, (B)(6) 2015 AND (B)(6) 2016 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED OR PARTIALLY EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FOR THE GORE-TEX\u00ae SOFT TISSUE PATCH; REMOVAL OF INFECTED MESH; RECURRENT INCISIONAL HERNIA; ABSCESS; CHRONIC INFECTION & INFLAMMATION; LYSIS OF ADHESION'S; SEVERE PAIN, THERE WAS A RECURRENT DEFECT BELOW THE GORE MESH. FOR THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL; ((B)(6) 2015) EXCISION OF ELLIPTICAL SKIN AND SUBCUTANEOUS TISSUE AND SINUS TRACT OF THE ABSCESS, DRAINAGE OF ABDOMINAL WALL AND INTRA-ABDOMINAL ABSCESS AND PARTIAL MESH EXCISION, ((B)(6) 2016) REMOVAL OF INFECTED MESH, INCISIONAL HERNIA REPAIR, LYSIS OF ADHESION'S, LAPAROTOMY DUE TO INFECTED MESH, ABSCESS, DRAINAGE OF SINUS TRACT AND ABSCESS CAVITY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED." }, { "mdr_text_key": "321769238", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "324586866", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: MEDICAL HISTORY: SURGICAL HISTORY: (B)(6) 2009: EXPLORATORY LAPAROTOMY. LYSIS OF ADHESIONS FOR 30 MINUTES. OPEN INCISIONAL HERNIA REPAIR WITH MESH. ADVANCEMENT OF CUTANEOUS FLAPS. IMPLANT: GORE-TEX\u00ae SOFT TISSUE PATCH. (B)(6) 2013: ABDOMINAL WALL EXPLORATION, REMOVAL OF PORTION OF MESH, WITH DRAINAGE OF ABDOMINAL WALL ABSCESS AND INTRA-ABDOMINAL ABSCESS. (B)(6) 2013: EXPLORATORY LAPAROTOMY. EXTENSIVE LYSIS OF ADHESIONS, ONE HOUR. REMOVAL OF INFECTED MESH. PARTIAL OMENTECTOMY. ABDOMINAL WASHOUT. ADVANCEMENT OF CUTANEOUS FLAPS. ABDOMINAL CLOSURE. (B)(6) 2013: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH. LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS, 2.5 HOURS. LAPAROSCOPIC DRAINAGE OF ABDOMINAL WALL SEROMA. IMPLANT: GORE\u00ae DUALMESH\u00ae BIOMATERIAL. (B)(6) 2015: EXCISION OF ELLIPTICAL SKIN AND SUBCUTANEOUS TISSUE AND SINUS TRACT OF THE ABSCESS. DRAINAGE OF ABDOMINAL WALL AND INTRAABDOMINAL ABSCESS. PARTIAL MESH EXCISION. (B)(6) 2016: LAPAROTOMY. REMOVAL OF INFECTED MESH. ADVANCEMENT OF MYOCUTANEOUS FLAPS. INCISIONAL HERNIA REPAIR. EXTENSIVE LYSIS OF ADHESIONS X1 HOUR. CLOSURE WITH RETENTION SUTURES. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2009: (B)(6) HOSPITALS. (B)(6)MD. INDICATIONS: \u00bf\u00bf WHO HAD A PREVIOUS INCISIONAL HERNIA REPAIR ABOUT A YEAR AGO WITH SURGISIS MESH. THE PATIENT PRESENTED TO THE CLINIC WITH RECURRENCE THAT WAS CONFIRMED ON A CT SCAN, WITH NO INCARCERATION OR STRANGULATION. THE PATIENT WAS SCHEDULED FOR RECURRENT OPEN INCISIONAL HERNIA REPAIR.\u00bf IMPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY. LYSIS OF ADHESIONS FOR 30 MINUTES. OPEN INCISIONAL HERNIA REPAIR WITH MESH. ADVANCEMENT OF CUTANEOUS FLAPS. IMPLANT: GORE-TEX\u00ae SOFT TISSUE PATCH [1320030020/06746265, 20CM X 30CM X 2CM] IMPLANT #1 DATE: NOVEMBER 17, 2009 (HOSPITALIZATION DATES UNKNOWN) (B)(6) 2009: (B)(6) HOSPITALS. (B)(6) MD. ASSISTANTS: (B)(6) MD/(B)(6) PA-C. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: MINIMAL. SPECIMENS: HERNIA SAC AND PART OF OLD MESH SENT TO PATHOLOGY. PROCEDURE: \u00bfA MIDLINE INCISION WAS MADE USING A 10 BLADE SCALPEL. THE INCISION WAS DEEPENED THROUGH SUBCUTANEOUS TISSUE USING ELECTROCAUTERY. BLUNT DISSECTION WAS DONE IN THE SUBCUTANEOUS PLANE TO AVOID ANY INJURY OF THE HERNIA CONTENT. LYSIS OF ADHESIONS WAS THEN DONE BETWEEN THE OMENTUM AND THE ABDOMINAL WALL, AND THE HERNIA SAC WAS EXCISED. ALSO, BETWEEN THE BOWEL AND THE ABDOMINAL WALL. LYSIS OF ADHESIONS LASTED FOR 30 MINUTES. AFTER THE ABDOMINAL CAVITY WAS ENTERED, THE BOWEL WAS EXAMINED. THIS DID NOT SHOW ANY ABNORMALITY, NO ENTEROTOMIES. PART OF THE OLD SURGISIS MESH WAS EXCISED AND SENT TO PATHOLOGY. THE HERNIA DEFECT MEASURED ABOUT 10 X 15 CM. WE THEN PROCEEDED WITH REPAIR OF THE HERNIA USING A GORE SOFT TISSUE PATCH, 20 X 25 CM. THIS WAS PLACED IN UNDERLAY FASHION AND SECURED TO THE FASCIA USING #0 GORE SUTURES IN INTERRUPTED FASHION, OBTAINING AT LEAST 4 CM CIRCUMFERENTIAL MARGIN. THIS WAS DONE AFTER ADVANCEMENT CUTANEOUS FLAPS WERE PERFORMED BY MOBILIZING THE SKIN AND SUBCUTANEOUS TISSUE OFF THE FASCIA BILATERALLY TO ALLOW APPROXIMATION OF THE FASCIA AND DECREASE THE TENSION ON THE REPAIR. THIS WAS DONE USING ELECTROCAUTERY. HEMOSTASIS WAS ACHIEVED THROUGHOUT THE PROCEDURE. BETADINE IRRIGATION WAS DONE AS WELL AS SALINE IRRIGATION. A 19-FRENCH ROUND BLAKE DRAIN WAS THEN PLACED IN THE SUBCUTANEOUS TISSUE AND THEN BROUGHT OUT THROUGH A SEPARATE STAB INCISION AND SECURED TO THE SKIN USING 2-0 NYLON SUTURE. THE SUBCUTANEOUS TISSUE WAS THEN CLOSED USING 3-0 VICRYL SUTURE IN INTERRUPTED FASHION AND THE SKIN WAS CLOSED USING 2-0 NYLON SUTURE IN INTERRUPTED VERTICAL MATTRESS FASHION. THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS OCCURRED DURING THE OPERATION. AT THE END OF THE PROCEDURE, COUNTS OF SPONGE AND NEEDLE WERE ALL CORRECT. THE PATIENT WAS EXTUBATED AND TRANSFERRED TO PACU IN STABLE CONDITION.\u00bf (B)(6) 2009: (B)(6) HOSPITALS. IMPLANT LOG: INVENTORY ITEM: \u00bfPATCH SOFT TISSUE 20CM 1320030020.\u00bf IMPLANT NAME: \u00bfPATCH SOFT TISSUE 20 X 30CM 2CM THICK 1320030020 - LOG25693.\u00bf MODEL/CAT NO.: 1320030020. LOT NUMBER: 06746265. AREA: ABDOMEN. NUMBER USED: 1. MANUFACTURER: WL GORE & ASSOCIATES. EXPIRATION DATE: 5/27/2014. RELEVANT MEDICAL INFORMATION: NO INFORMATION. REVISION #1 PREOPERATIVE COMPLAINTS: (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH THE HISTORY OF INCISIONAL HERNIA REPAIR PRESENTED WITH ABDOMINAL PAIN, FEVER AND FATIGUE. CT SCAN SHOWED A FLUID COLLECTION ABOVE AND BELOW THE MESH AND THE PATIENT WAS DIAGNOSED WITH MESH INFECTION AND SCHEDULED FOR EXPLORATION.\u00bf REVISION #1 PROCEDURE: ABDOMINAL WALL EXPLORATION, REMOVAL OF PORTION OF MESH, WITH DRAINAGE OF ABDOMINAL WALL ABSCESS AND INTRA-ABDOMINAL ABSCESS. REVISION #1 DATE: (B)(6) 2013 (HOSPITALIZATION DATES UNKNOWN) (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: ABDOMINAL PAIN, MESH INFECTION. ANESTHESIA: GENERAL AND LOCAL. ESTIMATED BLOOD LOSS: MINIMAL. SPECIMENS: CULTURE AND SENSITIVITY OF ABSCESS, PART OF MESH FOR CULTURE AND SENSITIVITY. PROCEDURE: \u00bfAFTER GENERAL ANESTHESIA WAS INDUCED AN INCISION WAS MADE IN THE MIDLINE USING A I0 BLADE SCALPEL. THERE WAS A SMALL ABSCESS IN THE SUBCUTANEOUS TISSUE AND THIS WAS DRAINED AND SENT FOR CULTURE AND SENSITIVITY. THERE WAS NO RECURRENCE OF THE HERNIA. THE MESH WAS IDENTIFIED. THERE WAS A BULGE BELOW THE MESH. AFTER COPIOUS IRRIGATION OF THE SKIN AND SUBCUTANEOUS TISSUE WAS DONE WITH SALINE MIXED WITH VANCOMYCIN A SMALL INCISION WAS THEN MADE IN THE MESH AND THE INTRA-ABDOMINAL ABSCESS BELOW THE MESH WAS DRAINED. THERE WAS ALSO A SMALL ABSCESS THAT WAS NOT FREE IN THE ABDOMINAL CAVITY. THIS WAS LOCALIZED IN THE AREA BELOW THE MESH. THERE WAS NO OTHER PATHOLOGY IDENTIFIED. PART OF THE REDUNDANT MESH WAS REMOVED. COPIOUS IRRIGATION WAS DONE USING VANCOMYCIN AND SALINE. THE MESH WAS THEN CLOSED LEAVING A SMALL OPENING IN THE MESH TO DRAIN ANY COLLECTION BELOW THE MESH AND A 10 FRENCH FLAT JP DRAIN WAS THEN PLACED ON TOP OF THE MESH AND BROUGHT OUT THROUGH A SEPARATE STAB INCISION TO THE LEFT OF THE WOUND AND SECURED TO THE SKIN USING A 2-0 NYLON SUTURE. THE PLAN IS TO TRY TO PRESERVE THE MESH. COPIOUS IRRIGATION WAS THEN AGAIN PERFORMED AND THE SKIN WAS LEFT OPEN AND THE INTERRUPTED VERTICAL MATTRESS 2-0 NYLON SUTURES WERE TAKEN AND LEFT UNTIED FOR DELAYED PRIMARY CLOSURE. IODOFORM PACK WAS PLACED. THE SUTURES USED FOR THE MESH WERE 2-0 PROLENE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED DURING THE OPERATION. BY THE END OF THE PROCEDURE THE COUNT, SPONGE AND NEEDLE WERE ALL CORRECT.\u00bf EXPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH HISTORY OF VENTRAL HERNIA REPAIR, WHO DEVELOPED MESH INFECTION. ATTEMPT SALVAGE THE MESH WERE NOT SUCCESSFUL AND THE PATIENT WAS SUBSEQUENTLY SCHEDULED FOR REMOVAL OF THE MESH.\u00bf EXPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY. EXTENSIVE LYSIS OF ADHESIONS, ONE HOUR. REMOVAL OF INFECTED MESH. PARTIAL OMENTECTOMY. ABDOMINAL WASHOUT. ADVANCEMENT OF CUTANEOUS FLAPS. ABDOMINAL CLOSURE. EXPLANT #1 DATE: (B)(6) 2013 (HOSPITALIZATION DATES UNKNOWN) (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: ABDOMINAL PAIN, INFECTED MESH. ANESTHESIA: GENERAL AND LOCAL. ESTIMATED BLOOD LOSS: MINIMAL. PROCEDURE: \u00bfMIDLINE LAPAROTOMY INCISION WAS MADE USING 10-BLADE SCALPEL AND INCISION WAS DEEPENED THROUGH THE SUBCUTANEOUS TISSUES WITH ELECTROCAUTERY. INCISION EXTENDED FROM THE XIPHOID TO THE INFRAUMBILICAL REGION. THE ABDOMINAL CAVITY WAS ENTERED WITHOUT INJURY. LYSIS OF ADHESIONS WAS DONE, FREEING THE OMENTUM FROM THE ABDOMINAL WALL. THIS WAS THEN CARRIED ALL THE WAY DOWN TO THE MESH. THERE WAS EXTENSIVE SCARRING AND ADHESIONS IN THIS AREA AND LYSIS OF ADHESIONS WAS DONE FOR ABOUT ONE HOUR UNTIL THE MESH WAS COMPLETELY REMOVED. THE SUTURES WERE CUT AND THERE WAS NO EVIDENCE OF ABSCESS. THE MESH WAS SEVERELY ADHERENT TO THE ABDOMINAL WALL IN THE OMENTUM AND THIS WAS FREED USING GENTLE BLUNT DISSECTION AS WELL AS SHARP DISSECTION WITH METZ AND ALSO ELECTROCAUTERY. NO INJURY WAS ENCOUNTERED. THE MESH WAS THEN SENT FOR CULTURES AND GROSS EXAMINATION. THE CAPSULE UNDER THE MESH WHICH FORMED THE WALL OF THE ABSCESS CAVITY THAT WAS DRAINED IN THE LAST SURGERY WAS ALSO EXCISED OFF THE OMENTUM AND ALSO SENT TO PATHOLOGY WITH A PORTION OF THE OMENTUM. A SMALL DEFECT AT THE OMENTUM AFTER THE PARTIAL OMENTECTOMY WAS THEN CLOSED USING #2-0 VICRYL SUTURE IN PURSE STRING FASHION TO AVOID INTERNAL HERNIA. AFTER THE INFECTED TISSUE WAS REMOVED, GLOVES AND INSTRUMENTS WERE CHANGED AND COPIOUS IRRIGATION OF THE ABDOMINAL CAVITY WITH SALINE WAS DONE. EXPLORATORY LAPAROTOMY SHOWED NO OTHER PATHOLOGY. THE SMALL BOWEL WAS RUN FROM THE LIGAMENT OF TREITZ TO THE ILEOCECAL VALVE. THE COLON WAS INSPECTED. THE LIVER WAS PALPATED AND NO NODULES WERE FELT. NO PATHOLOGY WAS IDENTIFIED IN THE STOMACH OR OTHER ABDOMINAL ORGANS. EXPLORATORY LAPAROTOMY WAS OTHERWISE NEGATIVE. AFTER ABDOMINAL WASHOUT WAS DONE WE THEN PROCEEDED WITH ADVANCEMENT OF CUTANEOUS FLAPS TO CLOSE THE FASCIA IN THE MIDLINE. SKIN AND SUBCUTANEOUS TISSUE WERE MOBILIZED OF THE FASCIA BILATERALLY USING ELECTROCAUTERY AS WELL AS BLUNT DISSECTION. PERFORATORS WERE CONTROLLED USING ELECTROCAUTERY AND #3 AND #2-0 VICRYL TIES. HEMOSTASIS WAS ACHIEVED. MOBILIZATION WAS DONE BILATERALLY, APPROXIMATING THE FASCIA IN THE MIDLINE. THIS WAS DONE ALL THE WAY LATERAL TO THE MID CLAVICULAR LINE. THERE WAS NO COMPROMISE OF THE BLOOD SUPPLY OF THE SKIN. THE FASCIA REACHED THE MIDLINE WITH NO TENSION. THE FASCIA WAS THEN CLOSED USING #0-VICRYL SUTURE IN INTERRUPTED FIGURE-OF-EIGHT FASHION. SUBCUTANEOUS TISSUE WAS THEN COPIOUSLY IRRIGATED AND THEN WAS PACKED WITH LODOFORM PACK AND THE SKIN AND SUB-CU WERE LEFT OPEN FOR DELAYED PRIMARY CLOSURE. #2-0 NYLON SUTURES WERE TAKEN IN VERTICAL MATTRESS FASHION AND LEFT UNTIED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS OCCURRED DURING THE OPERATION. AT THE END OF THE PROCEDURE THE COUNT OF SPONGE AND NEEDLE WERE ALL CORRECT. THE PATIENT WAS THEN EXTUBATED AND TRANSFERRED TO PACU IN STABLE CONDITION. (B)(6), PA-C, ASSISTED ME THROUGHOUT THE PROCEDURE WITH RETRACTION, EXPOSURE, REMOVAL OF MESH AND CLOSING THE ABDOMEN.\u00bf (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. PATHOLOGY. SPECIMENS RECEIVED: ABSCESS WALL WITH OMENTUM AND MESH FOR GROSS EXAM AND CULTURE. FINAL PATHOLOGIC DIAGNOSIS: PORTION OF OMENTAL TISSUE WITH MARKED REACTIVE FIBROSIS AND GRANULATION TISSUE. MESH MATERIAL WITH ASSOCIATED REACTIVE FIBROSIS. GROSS DESCRIPTION: PART A: \u00bfABSCESS WALL WITH OMENTUM\u00bf. IT CONSISTS OF A 5.0 X 4.0 X 1.2 CM TAN-BROWN, FOCALLY NECROTIC, MEMBRANOUS TISSUE, AND A 5.0 X 5.0 X 0.5 CM YELLOW-TAN, LOBULATED FIBROADIPOSE TISSUE. PART B: \"MESH FOR GROSS EXAM AND CULTURE\". IT CONSISTS OF A 12.0 X 8.5 X 0.3 CM TAN-PINK FLAT MATERIAL, WITH ATTACHED 1.8 X 1.6 X 1.0 CM TAN-BROWN, SOFT TISSUE.\u00bf RELEVANT MEDICAL INFORMATION: NO INFORMATION. IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH HISTORY OF MULTIPLE INCISIONAL HERNIAS. THE LAST REPAIR WAS DONE PRIMARILY AFTER INFECTED MESH WAS REMOVED. THE PATIENT WAS SUBSEQUENTLY DOING WELL UNTIL SHE WAS HAVING CARDIAC CATHETERIZATION AND THE PATIENT STATED THAT AFTER THE PROCEDURE SHE DEVELOPED RECURRENCE OF THE HERNIA. PLEASE REFER TO THE PATIENT'S CLINIC NOTES FOR DETAILS. THE PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND WAS SCHEDULED FOR LAPAROSCOPIC REPAIR.\u00bf IMPLANT #2 PROCEDURE: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH. LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS, 2.5 HOURS. LAPAROSCOPIC DRAINAGE OF ABDOMINAL WALL SEROMA. IMPLANT: GORE\u00ae DUALMESH\u00ae BIOMATERIAL [1DLMC04/10364142, 25 CM X 19CM]. IMPLANT #2 DATE: (B)(6), 2013 (HOSPITALIZATION (B)(6), 2013) (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA; EXTENSIVE INTRAABDOMINAL ADHESIONS WITH INCARCERATION OF SMALL BOWEL, LARGE BOWEL AND OMENTUM. ANESTHESIA: GENERAL AND LOCAL. SPECIMENS: HERNIA SAC FOR GROSS EXAMINATION ONLY. FINDINGS: \u00bfEXTENSIVE INTRAABDOMINAL ADHESIONS WITH INCARCERATED SMALL AND LARGE BOWEL AND OMENTUM. SEROMA IN THE HERNIA SAC. HERNIA DEFECT WAS 11 X 7 CM.\u00bf PROCEDURE: \u00bfTHE PATIENT HAS A HISTORY OF RECENT CARDIAC STENT AND, AFTER EXTENSIVE DISCUSSION WITH THE PATIENT AND HUSBAND AND WEIGHING THEIR RISKS VS. BENEFITS, DECISION WAS MADE TO KEEP HER ON PLAVIX INTRAOPERATIVELY TO AVOID THE RISK OF STENT OCCLUSION OR ANY ADVERSE CARDIAC EVENT. A FOLEY CATHETER WAS PLACED. PNEUMOPERITONEUM WAS ACHIEVED VIA 5 MM VISIPORT TECHNIQUE IN THE LEFT UPPER QUADRANT AT THE AXILLARY LINE UNDER DIRECT VISUALIZATION WITH 5 MM FLEX TIPPED SCOPE. NO INJURY OCCURRED FROM ACCESS. PNEUMOPERITONEUM WAS ACHIEVED TO 15 MMHG. ALL THE OTHER PORTS WERE DILATING VERSASTEP PORTS. THE SKIN WAS INFILTRATED WITH 1% LIDOCAINE PLAIN AND 0.5% MARCAINE PLAIN MIXED 1:1 BEFORE ANY SKIN INCISION. PORTS WERE THEN PLACED UNDER VISION. WE STARTED WITH 5 MM DILATING VERSASTEP PORT IN THE LEFT LOWER QUADRANT AT THE AXILLARY LINE. THERE WERE EXTENSIVE ADHESIONS NOTED IN THE ABDOMEN. THERE WERE EXTENSIVE OMENTAL ADHESIONS WITH THE ABDOMINAL WALL, AS WELL AS ADHESIONS BETWEEN THE SMALL AND LARGE BOWEL AND THE TRANSVERSE COLON THAT WAS ALSO ADHERENT INSIDE THE HERNIA AND ALSO SMALL BOWEL LOOPS THAT WERE ADHERENT AND INCARCERATED IN THE HERNIA DEFECT AND TO THE ABDOMINAL WALL. WE STARTED WITH LAPAROSCOPIC LYSIS OF ADHESIONS USING LAPAROSCOPIC SCISSORS, FREEING THE OMENTUM IN THE LOWER ABDOMEN. ANOTHER 5 MM PORT WAS THEN PLACED IN THE SUPRAPUBIC REGION UNDER DIRECT VISION. WE THEN PROCEEDED WITH LYSIS OF ADHESIONS IN THE RIGHT ABDOMEN. AS MENTIONED, THE ADHESIONS WERE EXTENSIVE IN THE ABDOMEN SECONDARY TO THE PATIENT'S MULTIPLE PREVIOUS LAPAROTOMIES. GENTLE BLUNT ADHESION LYSIS WAS DONE, AS WELL AS SHARP DISSECTION WITH LAPAROSCOPIC SCISSORS AND ELECTROCAUTERY FOR FLESHY ADHESIONS, WITHOUT INJURY TO THE BOWEL. NO ENTEROTOMIES WERE ENCOUNTERED. THE HERNIA DEFECT WAS LARGE AND THERE WAS TRANSVERSE COLON, AS WELL AS SMALL BOWEL AND OMENTUM, INCARCERATED IN THE HERNIA SAC. METICULOUS DISSECTION WAS DONE, FREEING ALL THE BOWEL LOOPS INTO THE ABDOMINAL CAVITY ALONG AVASCULAR PLANES. NO INJURY OCCURRED. THE ADHESIONS INVOLVE THE ENTIRE ABDOMEN. WE PLACED ONE PORT AT A TIME AFTER FREEING SOME ADHESIONS. AT THE END, A TOTAL OF FIVE PORTS WERE PLACED, THE THREE PORTS MENTIONED EARLIER IN THE DICTATION, AND THEN ANOTHER 12 MM PORT IN THE RIGHT UPPER QUADRANT AT THE AXILLARY LINE AND 5 MM PORT IN THE RIGHT LOWER QUADRANT AT THE AXILLARY LINE. LYSIS OF ADHESIONS LASTED FOR 2.5 HOURS AND THIS, IN ADDITION TO THE PATIENT BEING ON PLAVIX TO PROTECT HER CARDIAC STENT, ADDED TECHNICAL DIFFICULTIES TO THE PROCEDURE. HEMOSTASIS WAS ACHIEVED THROUGHOUT THE PROCEDURE WITH ELECTROCAUTERY, AS WELL AS SURGISEAL AND FLOSEAL AND 5 MM CLIPS. OVERALL, THE BLOOD LOSS WAS MINIMAL. AFTER LYSIS OF ADHESIONS WAS PERFORMED, THE HERNIA WAS MEASURED AND THIS WAS FOUND TO BE 11 CM LONGITUDINALLY BY 7 CM TRANSVERSELY. THERE WAS A SEROMA IN THE HERNIA SAC AND THE SEROMA WAS OPENED USING LAPAROSCOPIC SCISSORS WITH ELECTROCAUTERY AND DRAINED INTO THE PERITONEAL CAVITY. THE HERNIA SAC WAS THICK AND THIS WAS EXCISED USING SCISSORS AND SENT TO PATHOLOGY FOR GROSS EXAMINATION ONLY. WE THEN PROCEEDED WITH REPAIR OF THE HERNIA. THE PATIENT WAS EVALUATED BY DR. (B)(6) AND WAS CLEARED FOR MESH PLACEMENT. I ALSO CONFIRMED THAT TODAY WITH DR. (B)(6) OVER THE PHONE BEFORE PLACEMENT OF THE MESH AND I EXPLAINED TO HIM THE OPERATIVE FINDINGS. THERE WAS NO EVIDENCE OF INFECTION OR ABSCESS. AFTER MY DISCUSSION WITH DR. (B)(6), THE PATIENT WAS ASSESSED TO BE CLEAR FOR PLACEMENT OF NON-ABSORBABLE MESH TO MINIMIZE THE RISK OF RECURRENCE, AS SHE HAS LOW RISK OF INFECTION OF THE MESH. A GORE DUAL MESH WAS USED TO REPAIR THE HERNIA. THIS WAS A 19 X 15 CM MESH OBTAINING 4 CM CIRCUMFERENTIAL MARGIN. THE MESH WAS SECURED IN PLACE USING #0 GORE TRANSFASCIAL FIXING SUTURES AND PRO TACKS. AFTER PERFORMING THE REPAIR, LAPAROSCOPIC EXAMINATION OF THE ABDOMEN CONFIRMED THAT THE MESH WAS PROPERLY PLACED. THERE WAS NO EVIDENCE OF INJURY. THERE WAS NO EVIDENCE OF BLEEDING OR INTRAABDOMINAL COMPLICATIONS. PNEUMOPERITONEUM WAS THEN DESUFFLATED UNDER DIRECT VISION AND PORTS WERE REMOVED. THE INCISIONS WERE CLOSED USING 4-0 MONOCRYL SUTURE IN SUBCUTICULAR FASHION AND LIQUIBAND. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED DURING THE OPERATION.\u00bf (B)(6) 213: (B)(6) HOSPITAL. IMPLANT LOG: \u00bfGORE DUAL MESH\u00bf. MODEL#: 1DLMC04. LOT#: 10364142. SIZE: \u00bf15 X 19 X 1 CM\u00bf. EXPIRATION DATE: 2017-04. SITE: INTRABDOMINAL. (B)(6) 2013: (B)(6) HOSPITALS, INC. (B)(6), MD. PATHOLOGY. SPECIMEN: HERNIA SAC. GROSS DESCRIPTION: \u00bfIT CONSISTS OF A 5.5 X 5.0 X 0.9 CM PIECE OF SMOOTH, TAN, GLISTENING TISSUE WITH CAUTERIZED AREAS.\u00bf PARTIAL EXPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH HISTORY OF LAPAROSCOPIC INCISIONAL HERNIA REPAIR APPROXIMATELY TWO YEARS AGO. THE PATIENT HAD MULTIPLE ABDOMINAL SURGERIES AND HISTORY OF MRSA INFECTIONS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AT (B)(6) YESTERDAY, HAD A CT SCAN, AND WAS FOUND TO HAVE FLUID COLLECTION ABOVE AND BELOW THE MESH. SHE HAS INTERMITTENT SINUS DRAINAGE FROM THE ABDOMINAL WALL IN THE SUPRAUMBILICAL AREA FOR THE PAST FOUR WEEKS THAT HAS BEEN PROGRESSIVELY GETTING WORSE. SHE HAD CHILLS; DENIES FEVER. SHE HAS ABDOMINAL PAIN. THE PATIENT WAS TRANSFERRED TO PRESTON MEMORIAL HOSPITAL AND WAS SEEN. EVALUATED, AND TAKEN TO THE OPERATING ROOM FOR DRAINAGE OF THE ABSCESS. I DISCUSSED WITH THE PATIENT IN DETAIL THAT WE WILL ATTEMPT TO SALVAGE THE MESH AND SHE WAS AGREEABLE TO THE PLAN.\u00bf PARTIAL EXPLANT #2 PROCEDURE: EXCISION OF ELLIPTICAL SKIN AND SUBCUTANEOUS TISSUE AND SINUS TRACT OF THE ABSCESS. DRAINAGE OF ABDOMINAL WALL AND INTRAABDOMINAL ABSCESS. PARTIAL MESH EXCISION. PARTIAL EXPLANT #2 DATE: (B)(6) 2015 (HOSPITALIZATION (B)(6), 2015) (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: ABDOMINAL WALL ABSCESS, INTRAABDOMINAL ABSCESS AND ABDOMINAL PAIN. ANESTHESIA: GENERAL AND LOCAL. SPECIMENS: CULTURE AND SENSITIVITY FROM THE ABSCESS, AEROBIC AND ANAEROBIC. PORTION OF MESH FOR CULTURE. SKIN AND SUBCUTANEOUS TISSUE WITH SINUS TRACT TO PATHOLOGY. PROCEDURE: \u00bfAFTER GENERAL ANESTHESIA WAS INDUCED, THE SINUS TRACT WAS IN THE MIDLINE, MIDWAY BETWEEN THE XIPHOID AND THE UMBILICUS. AN ELLIPTICAL INCISION WAS MADE SURROUNDING THE TRACT AND THE INDURATED SKIN USING A 10-BLADE SCALPEL. INCISION WAS DEEPENED THROUGH THE SUBCUTANEOUS TISSUES WITH ELECTROCAUTERY. THE FASCIA WAS IDENTIFIED. THERE WAS A SUPERFICIAL ABSCESS POCKET ABOVE THE MESH AND THIS WAS SENT FOR CULTURE AND SENSITIVITY AND WAS DRAINED. THE SKIN AND SUBCUTANEOUS TISSUE, INCLUDING THE SINUS TRACT AND ABSCESS CAVITY, WAS REMOVED AND SENT TO PATHOLOGY. THE MESH WAS IDENTIFIED. THE MESH WAS INTACT. THERE WAS NO EVIDENCE OF RECURRENCE OF THE HERNIA. THERE WERE NO OTHER POCKETS ABOVE THE MESH. I THEN PROCEEDED WITH MAKING A SMALL INCISION IN THE MESH AND IMMEDIATELY THERE WAS A GUSH OF PUS. THERE WAS NO EVIDENCE OF STOOLS OR ANY ENTERIC CONTENTS. THERE WAS NO EVIDENCE OF ENTERIC OR COLONIC FISTULAS. THE PUS WAS SENT FOR CULTURE AND WAS EVACUATED. THIS WAS LOCALIZED AND ENCAPSULATED UNDER THE MESH WITH NO EVIDENCE OF SPREAD INTO THE FREE PERITONEAL CAVITY. I THEN PROCEEDED WITH IRRIGATION OF THE ABSCESS CAVITIES WITH HYDROGEN PEROXIDE. THEY WERE THEN IRRIGATED WITH BETADINE AND COPIOUS IRRIGATION WITH SALINE. AN 8-FRENCH JP DRAIN WAS THEN PLACED IN THE ABSCESS CAVITY BELOW THE MESH AND PART OF THE MESH WAS EXCISED AND REMOVED AND SENT FOR CULTURE TO REDUCE REDUNDANCY OF MESH IN THIS AREA AND DECREASE POTENTIAL SPACE FOR FLUID ACCUMULATION. THE MESH WAS THEN CLOSED USING 2-0 PROLENE IN A RUNNING FASHION. THE WOUND WAS AGAIN IRRIGATED AND HEMOSTASIS WAS ACHIEVED AND 1-INCH IODOFORM PACK WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED DURING THE OPERATION. AT THE END OF THE PROCEDURE, THE COUNT OF SPONGE AND NEEDLE WERE ALL CORRECT. THE PATIENT WAS THEN EXTUBATED AND TRANSFERRED TO PACU IN STABLE CONDITION.\u00bf \u00bfPLAN WILL BE TO CONTINUE ANTIBIOTICS AND WET-TO-DRY DRESSING B.I.D. THE PATIENT WILL GO HOME WITH A JP DRAIN AND SHE WILL RECEIVE JP MANAGEMENT TEACHING BEFORE DISCHARGE AND WE WILL PLAN FOR VANC DRESSING AT HOME.\u00bf (B)(6) 2015: (B)(6) HOSPITAL. (B)(6), PA/(B)(6), MD. PATHOLOGY. SPECIMENS RECEIVED: A. SKIN WITH SUBCUTANEOUS TISSUE WITH SINUS TRACT. FINAL PATHOLOGIC DIAGNOSIS: SKIN WITH SINUS TRACT, GRANULOMATOUS TISSUE, FIBROSIS, AND INFLAMMATION. GROSS DESCRIPTION: PART A SEATED FORMALIN LABELED \"BACKUS, CONNIE\" AND \"SKIN WITH SUBCUTANEOUS TISSUE WITH SINUS TRACT\u00bf- IT CONSISTS OF 5.7 X 1.9 CM ELLIPSE OF TAN SKIN EXCISED TO A DEPTH OF 1.7 CM. THE SKIN SURFACE CONTAINS A 0.5 X 0.3 CM SHALLOW DEPRESSION WITH A PITTED CENTER THAT IS 0.7 CM FROM THE CLOSEST PERIPHERAL SKIN MARGIN. THE CENTER IS PROBED AND COMMUNICATES WITH A SINUS TRACT THAT EXTENDS TO THE DEEP MARGIN. THE ATTACHED SUBCUTANEOUS TISSUE IS COMPOSED OF YELLOW, LOBULATED ADIPOSE T ISSUE WITH A FIRM YELLOW-TAN AREA OF EXUDATE AT THE DEEP MARGIN. THE SPECIMEN IS SERIALLY SECTIONED TO REVEAL A PATENT SINUS TRACT AND A CUT SURFACE THAT IS A DULL YELLOW-ORANGE AND TAN. THE REMAINDER OF THE SPECIMEN DISPLAYS A FIRM, FIBROUS, CENTRALLY LOCATED TAN-GRAY CUT SURFACE THAT COMMUNICATES WITH THE DEEP MARGIN ALONG THE ENTIRE LENGTH OF THE SPECIMEN AND IS SURROUNDED BY SOFT, YELLOW LOBULATED ADIPOSE TISSUE.\u00bf EXPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2016: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH HISTORY OF MULTIPLE VENTRAL HERNIA REPAIRS. THE PATIENT HAS A HISTORY OF INCISIONAL HERNIA THAT WAS REPAIRED WITH GORE DUAL MESH AND THE PATIENT HAS RECURRENT HISTORY OF MESH INFECTIONS. SHE DEVELOPED MESH INFECTION WITH ATTEMPT TO SALVAGE THE MASS IN LATE 2015 WAS NOT SUCCESSFUL. THE PATIENT HAD PURULENT DRAINAGE WITH A SINUS OPENING AT THE LEVEL OF THE UMBILICUS AND THE MESH NEEDED REMOVAL. THE PATIENT WAS SEEN IN THE OFFICE AND SCHEDULED FOR SURGERY.\u00bf EXPLANT #2 PROCEDURE: LAPAROTOMY. REMOVAL OF INFECTED MESH. ADVANCEMENT OF MYOCUTANEOUS FLAPS. INCISIONAL HERNIA REPAIR. EXTENSIVE LYSIS OF ADHESIONS X1 HOUR. CLOSURE WITH RETENTION SUTURES. EXPLANT #2 DATE: (B)(6) 2016 (HOSPITALIZATION (B)(6) 2016) (B)(6) 2016: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INFECTED MESH; HISTORY OF INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: INFECTED MESH; HISTORY OF INCISIONAL HERNIA; PLUS EXTENSIVE INTRAABDOMINAL ADHESIONS. ANESTHESIA: GENERAL AND LOCAL. SPECIMENS: MESH AND ABSCESS CAVITY FOR CULTURE. PROCEDURE: \u00bfAN INCISION WAS MADE IN THE MIDLINE USING 10-BLADE SCALPEL AND DEEP SUBCUTANEOUS TISSUE WITH ELECTROCAUTERY ALONG THE OLD SCAR. THE FASCIA WAS OPENED ABOVE AND BELOW THE HERNIA THAT WAS REPAIRED PREVIOUSLY IN AN UNDERLAY FASHION. THE MESH WAS VISIBLE WITH PUS ABOVE THAT WAS SUCTIONED. THE FASCIA WAS OPENED IN THE MIDLINE AND WE PROCEEDED WITH LYSIS OF ADHESIONS. THIS WAS DONE USING ELECTROCAUTERY, GENTLE BLUNT DISSECTION, AND SCISSORS. THE MESH WAS COMPLETELY REMOVED AND SENT FOR CULTURES. THERE WAS AN ABSCESS CAVITY UNDERNEATH THE MESH AND THIS WAS ADHERENT TO THE BOWEL, AS WELL AS TO THE ABDOMINAL WALL, AND THIS WAS REMOVED USING VERY GENTLE DISSECTION. AS WELL AS METZ. NO BOWEL INJURY OCCURRED. WE THEN PROCEEDED WITH LYSIS OF ADHESIONS OF THE SMALL BOWEL, AS THE BOWEL WAS ADHERENT TO MULTIPLE AREAS INCLUDING INTERLOOP ADHESIONS OF THE ABDOMINAL WALL AND PELVIS. OVERALL LYSIS OF ADHESIONS THROUGHOUT THE PROCEDURE LASTED FOR ONE HOUR. THE ABDOMEN WAS COPIOUSLY IRRIGATED WITH 5 LITERS OF SALINE UNTIL THE RETURN WAS CLEAR AND WE PROCEEDED WITH CLOSURE. PER MY PREVIOUS DISCUSSION WITH THE PATIENT, WE PLAN NO MESH PLACEMENT TODAY AND PLAN MEDIALIZATION OF THE FASCIA WITH ADVANCEMENT OF MYOCUTANEOUS FLAPS. THE SKIN AND SUBCUTANEOUS TISSUE WERE MOBILIZED OVER THE FASCIA BILATERALLY UNTIL THE FASCIA WAS MEDIALIZED AND REACHED THE MIDLINE WITHOUT TENSION. I EXCISED THE SINUS TRACT TO FACILITATE HEALING. THE FASCIA WAS THEN CLOSED USING #1 MAXON LOOP SUTURE IN RUNNING FASHION AND, BECAUSE OF THE HISTORY OF CHRONIC INFECTION AND POSSIBILITY OF DEHISCENCE, I ALSO PLACED A #1 BIOSYN RETENTION SUTURE IN A C-SHAPED FASHION. PLANNING DELAYED PRIMARY CLOSURE OF THE SKIN SO 2-0 NYLON SUTURES IN A VERTICAL MATTRESS FASHION WERE TAKEN AND LEFT UNTIED AND THE WOUND WAS PACKED WITH IODOFORM. BECAUSE OF THE INFECTION, THE UMBILICUS IS LOST. THE PATIENT MIGHT NEED RECONSTRUCTION OF THE UMBILICUS IN THE FUTURE. THIS WAS NOT IDENTIFIED TODAY BEFORE THE SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED DURING THE OPERATION. FOLLOWING THE PROCEDURE, THE COUNT OF SPONGE AND NEEDLE WERE ALL CORRECT. THE PATIENT WAS THEN EXTUBATED AND TRANSFERRED TO PACU IN STABLE CONDITION.\u00bf (B)(6) 2016: MONONGALIA HEALTH SYSTEM. PROVIDER NOT LISTED. PATHOLOGY. FINAL DIAGNOSIS: \u00bfABSCESS CAVITY. FIBROADIPOSE TISSUE SHOWING HEMORRHAGE, NECROSIS AND ABSCESS FORMATION. PAS FUNGAL STAIN IS NEGATIVE.\u00bf (B)(6) 2016: (B)(6) HOSPITAL. (B)(6). PATHOLOGY. SPECIMEN: ABSCESS CAVITY. GROSS DESCRIPTION: \u00bfTHE SPECIMEN IS LABELED ABSCESS CAVITY. RECEIVED IS AN AGGREGATE OF GRAY-TAN SOFT PERITONEAL TISSUE AND YELLOW ADIPOSE. SPECIMEN MEASURES 6.5 X 5.0 X 1.7 CM. THE TISSUE IS RAGGED AND ROUGHENED. THERE ARE AREAS OF QUESTIONABLE VIABILITY. NO FOCAL LESION IS OBSERVED. AREAS OF THE TISSUE ARE HEMORRHAGIC. CUT SURFACE IS TAN-WHITE AND SMOOTH.\u00bf A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. \u00a0 IT SHOULD BE NOTED THAT THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "P.O. BOX 1408", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86004", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/11/2020;12/11/2020;02/03/2021;03/12/2021;12/14/2022" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "ELKTON", "manufacturer_contact_address_1": "1505 N. 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L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "1505 N. FOURTH STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86004", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86004", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20170430", "model_number": "1DLMC04", "catalog_number": "1DLMC04", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FTL", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00733132600977", "udi_public": "00733132600977", "openfda": { "device_name": "Mesh, Surgical, Polymeric", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/30/2020;10/23/2020;10/23/2020;10/23/2020;12/07/2022", "manufacturer_contact_country": "US", "date_changed": "20240108", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "1408", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200811", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "58 YR", "patient_sex": "Female", "patient_weight": "74 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20221214", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "10393692", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200730", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "21922", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MPD APC B/P", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319506955", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: CONCLUSION CODE REMAINS UNCHANGED. G4/G5: ADDED 510/PMK CODE." }, { "mdr_text_key": "323541535", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RELEVANT MEDICAL INFORMATION: ON (B)(6) 2009: (B)(6) HOSPITAL. (B)(6) , MD. OPERATIVE REPORT. [OPERATIVE REPORT START ON PAGE 2, PAGE ONE IS MISSING]. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. PROCEDURE: EXPLORATORY LAPAROTOMY. EXTENSIVE LYSIS OF ADHESIONS, 1 HOUR. REPAIR OF RECURRENT INCISIONAL HERNIA 10 X 10 CM WITH SURGISIS MESH. EXCISION AND DEBRIDEMENT OF INFECTED SKIN. PARTIAL OMENTECTOMY. ANESTHESIA: GENERAL. SPECIMEN: PORTION OF OMENTUM. COMPLICATIONS: NONE. CONDITION: STABLE. EXTUBATED AND TRANSFERRED TO PACU. INDICATION: 55-YEAR-OLD FEMALE WHO PRESENTED TO THE GENERAL SURGERY CLINIC ON (B)(6) 2009, WITH RECURRENT VENTRAL HERNIA 2 MONTHS AFTER REPAIR. THE PATIENT WAS ASSESSED AND WAS NOT FOUND TO HAVE ANY SYMPTOMS OR SIGNS OF INCARCERATION OR STRANGULATION. SHE WAS COMPLAINING OF PAIN AND DISCOMFORT FROM THE HERNIA AND WAS SCHEDULED FOR RECURRENT INCISIONAL HERNIA REPAIR. DESCRIPTION OF PROCEDURE: \u00bfAFTER OBTAINING INFORMED CONSENT, THE PATIENT WAS TAKEN TO THE OR, PLACED ON THE BED IN SUPINE POSITION AND WAS PREPPED AND DRAPED IN THE GENERAL SURGICAL FASHION. GENERAL ANESTHESIA WAS INDUCED. A MIDLINE LAPAROTOMY WAS DONE OVER THE HERNIA SITE USING A 10 BLADE SCALPEL. THE ABDOMINAL CAVITY WAS SAFELY ENTERED CEPHALAD TO THE HERNIA AND THEN LYSIS OF ADHESIONS WAS DONE ALONG THE MIDLINE UNTIL THE WHOLE INCISION WAS OPEN. THE HERNIA WAS IDENTIFIED AND WAS FOUND TO BE ABOUT 10 X 10 CM. THERE WERE FOUND TO BE EXTENSIVE ADHESIONS BETWEEN THE OMENTUM AND THE ABDOMINAL WALL AND THIS WAS TAKEN DOWN USING ELECTROCAUTERY AWAY FROM THE BOWEL. THERE WAS FOUND TO BE ADHESIONS BETWEEN THE SMALL BOWEL AND THE ABDOMINAL WALL, AND THESE WERE TAKEN DOWN USING SHARP DISSECTION WITH SCISSORS AS WELL AS DIGITAL BLUNT DISSECTION. LYSIS OF ADHESIONS LASTED FOR ABOUT 1 HOUR. AFTER LYSIS OF ADHESIONS WAS PERFORMED AND THE FASCIAL EDGES WERE FREED, THE HERNIA MEASURED ABOUT 10 X 10 CM. WE PROCEEDED WITH AN UNDERLYING REPAIR OF THE HERNIA USING SURGISIS MESH OBTAINING 4-CM CIRCUMFERENTIALLY OF MARGIN UNDER THE FASCIA. SURGISIS MESH WAS USED BECAUSE THE PATIENT HAD EVIDENCE OF A SKIN INFECTION AT THE SCAR AND THINNING OF THE SKIN IN THIS AREA. THE SURGISIS MESH WAS SECURED USING 0 VICRYL SUTURE IN INTERRUPTED FASHION. AFTER THE MESH WAS PLACED, THE WOUND WAS IRRIGATED AND THE INFECTED PORTION OF THE SKIN WAS DEBRIDED USING ELECTROCAUTERY AS WELL AS UNDERLYING SUBCUTANEOUS TISSUE AND SEND TO PATHOLOGY AS A SPECIMEN. THERE ARE NUMEROUS ADHESIONS. A PARTIAL OMENTECTOMY WAS DONE AS THERE WERE MULTIPLE DEFECTS IN THE OMENTUM AND THIS WAS DONE TO AVOID INTERNAL HERNIA. THE SKIN WAS THEN CLOSED USING 2-0 NYLON SUTURE IN INTERRUPTED VERTICAL MATTRESS FASHION. THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS OCCURRED. I WAS THE ATTENDING SURGEON AND WAS PRESENT AND SCRUBBED FOR THE ENTIRE PROCEDURE AND PERFORMED THE ENTIRE OPERATION. THERE WAS NO RESIDENT SCRUBBING ON THE PROCEDURE.\u00bf ON (B)(6) 2009: (B)(6) HOSPITAL. IMPLANT RECORD. IMPLANT: BIODESIGN, SURGISYS GOLD. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2012: (B)(6) . (B)(6) , MD, FACS, FASMBS. OFFICE NOTES. PRESENTS TODAY WITH 3 MONTH HISTORY OF ABDOMINAL PAIN. FATIGUE, FEVER, CHILLS, WAS TOLD SHE HAD A SEROMA. WEIGHT 134 LB. EXAM: ABDOMEN WITH MILD DIFFUSE TENDERNESS, NO PERITONEAL SIGN. IMPRESSION: I REVIEWED THE FILMS AND THE CT AND ULTRASOUND REPORTS AND THE PICTURE IS SUSPICIOUS OF MESH INFECTION. PLAN: SCHEDULE FOR EXPLORATORY LAPAROTOMY, MESH REMOVAL AND HERNIA REPAIR WITH ABSORBABLE MESH. I DISCUSSED THE FINDINGS AND PROCEDURE WITH THE PATIENT AND HUSBAND IN DETAILS INCLUDING RISKS AND BENEFITS AND COMPLICATIONS SUCH AS BLEEDING, INFECTION, DEEP VEIN THROMBOSIS, PULMONARY EMBOLISM, DEATH, HEART ATTACK, STROKE AND ANESTHESIA COMPLICATIONS. WE DISCUSSED COMPLICATIONS AS HERNIA RECURRENCE, BOWEL INJURY, CHRONIC PAIN. PATIENT UNDERSTANDS THE RISKS AND BENEFITS OF SURGERY AND WISHES TO PROCEED WITH THE OPERATION. ON (B)(6) 2013: (B)(6) HOSPITAL. [SIGNATURE ILLEGIBLE]. ANESTHESIA RECORD. WEIGHT 130 LB. ASA 3. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2013: (B)(6) HOSPITAL. LAB. ABDOMINAL FLUID- RARE GROWTH, GRAM POSITIVE COCCI. ABDOMINAL MESH- RARE GROWTH, STAPHYLOCOCCUS AUREUS. ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) [LAST NAME ILLEGIBLE]. ANESTHESIA RECORD. WEIGHT 134 LB. ASA 3. EXPLANT #1 DATE: (B)(6) 2013 (HOSPITALIZATION FROM (B)(6) 2013) RELEVANT MEDICAL INFORMATION: ON (B)(6) 2013: (B)(6) HOSPITAL. LAB. GLUCOSE 132 H (74-106), WBC 15.3 H (3.8-11.8). ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) , MD, FACS, FASMBS. DISCHARGE SUMMARY. ADMITTED: (B)(6) 2013. PRINCIPAL DIAGNOSIS ON ADMISSION: ABDOMINAL PAIN, INFECTED MESH. DIET AS TOLERATED. NO LIFTING MORE THAN 15 LBS. KEEP WOUND CLEAN, SHOWER, AVOID SCRUBBING OR SUBMERGING OF THE WOUND. HOSPITAL COURSE: HISTORY ON HERNIA REPAIRED DEVELOPED MESH INFECTION, ATTEMPT TO SALVAGE THE MESH WAS NOT SUCCESSFUL AND WAS SUBSEQUENTLY SCHEDULED FOR REMOVAL OF MESH. POST-OPERATIVELY THE PATIENT IS DOING WELL, WOUND WAS LEFT OPEN FOR PRIMARY CLOSURE. IODOFORM PACKING WAS REMOVED FROM WOUND ON POST-OPERATIVE DAY ONE AND THEN WET TO DRY DRESSINGS TWICE A DAY WAS DONE AND WOUND WAS CLOSED BY THE DAY OF PRIMARY CLOSURE ON 2/01/13, DISCHARGED HOME TODAY AND FOLLOW-UP IN TWO WEEKS AND SHE WILL FOLLOW-UP WITH DR. (B)(6) IN OFFICE. ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) , CRNA. ANESTHESIA RECORD. WEIGHT 152 LB. ASA 3. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) , RN. NURSE NOTES. NO COMPLAINT OF PAIN. PORT SITES X 5 WELL APPROXIMATED. NO DRAINAGE NOTED FROM PORT SITES. ABDOMINAL BINDER CLEAN AND DRY. ON (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) , MD, FACS, FASMBS. DISCHARGE SUMMARY. ADMITTED (B)(6) 2013. DIAGNOSIS ON ADMISSION: RECURRENT INCISIONAL HERNIA. DIET AS TOLERATED. NO LIFTING MORE THAN 15 LBS THE FIRST TWO WEEKS. KEEP WOUNDS CLEAN, SHOWER, AVOID SCRUBBING OR SUBMERGING OF THE WOUNDS. HOSPITAL COURSE: PROCEDURE WAS UNEVENTFUL. PATIENT STARTED ON LIQUID DIET WHICH SHE TOLERATED. SHE WAS AMBULATING. INITIALLY HAD URINARY RETENTION AND WAS STRAIGHT CATHED ONCE AND SUBSEQUENTLY THIS RESOLVED. DISCHARGED HOME IN STABLE CONDITION AND WILL FOLLOW-UP IN OFFICE. ON (B)(6) 2015. (B)(6) HOSPITAL. (B)(6) , MD, FACS, FASMBS. CONSULTATION. AT (B)(6) HOSPITAL EMERGENCY ROOM YESTERDAY WAS DIAGNOSED WITH FLUID COLLECTION AROUND THE MESH THAT WAS PLACED IN 2013. THE HOSPITAL CONTACTED US AND REQUESTED TRANSFER. SURGEON THERE STATED HE WAS NOT COMFORTABLE DEALING WITH HER CASE. PATIENT STATED PROBLEM STARTED FOUR WEEKS AGO WITH INTERMITTENT DRAINAGE PROGRESSIVELY WORSENING. HAD MUCOPURULENT DISCHARGE; CHILLS, DULL ABDOMINAL PAIN IN SUPRAUMBILICAL AREA. ADMITTED WITH NO NEW COMPLAINTS. EXAM: ABDOMEN SOFT, NON-DISTENDED. HAS A SINUS IN THE SUPRAUMBILICAL AREA WITH ERYTHEMA AND MILD INDURATION. IMAGING: I REVIEWED THE CT SCAN DONE AT (B)(6) . THERE IS A SUPRA-AND INFRA-MESH COLLECTION. IMPRESSION/PLAN: INTRAABDOMINAL FLUID COLLECTION; MESH INFECTION WITH RECURRENT SINUS DRAINAGE. CONTINUE LINEZOLID AND PAIN CONTROL. TAKE THE PATIENT TO OPERATING ROOM TODAY. I GAVE HER THE OPTION OF TRYING TO SALVAGE THE MESH BY DRAINAGE, DRAINING THE INFECTION AND LEAVE THE WOUND OPEN WITH PLACEMENT OF VAC DRESSING AND CONTINUING ANTIBIOTIC. THE OTHER OPTION IS TO GO IN AND COMPLETELY REMOVE THE MESH AND REPAIR WITH A BIOLOGIC MESH. I DISCUSSED THE RISK AND THE BENEFITS OF BOTH APPROACHES. I BELIEVE IT IS REASONABLE TO TRY TO SALVAGE THE MESH IF POSSIBLE AND THE PATIENT IS AGREEABLE TO THE PLAN. SHE UNDERSTANDS THERE IS A CHANGE THAT WE MIGHT NEED TO REMOVE THE MESH EVENTUALLY. I DISCUSSED THE RISK AND BENEFITS, INCLUDING BLEEDING, INFECTION HERNIA, CHRONIC PAIN, CHRONIC SINUSES, FISTULA, BOWEL INJURY, AND NEED FOR ADDITIONAL PROCEDURES. THE PATIENT UNDERSTANDS THE RISKS AND BENEFITS AND CONSENTS TO THE PROCEDURE WITH SURGERY. ON (B)(6) 2015. (B)(6) HOSPITAL. (B)(6) , MD. HISTORY AND PHYSICAL. CURRENTLY HAVING COMPLAINTS OF DISCHARGE AT SURGERY SITE. SHE IS FEELING COMFORTABLE OVERALL. HISTORY OF HYPERTENSION, GASTROESOPHAGEAL REFLUX DISEASE, IRRITABLE BOWEL SYNDROME, DEPRESSION, MYOCARDIAL INFARCTION IN 2000. MEDICATIONS INCLUDE ASPIRIN. EXAM: ABDOMEN SOFT, NON-DISTENDED. BOWEL SOUNDS ARE AUDIBLE. SURGERY SITE SHOWS MILD COLLECTION AND MILD TENDERNESS. ON (B)(6) 2015: (B)(6) HOSPITAL. [SIGNATURE ILLEGIBLE]. ANESTHESIA RECORD. WEIGHT 65-77 KG, BMI 26.5. DIABETES. ASA 3E. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2015: (B)(6) HOSPITAL. LAB. ABDOMEN- STAPHYLOCOCCI AUREUS. ON (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) , MD. DISCHARGE SUMMARY. ADMITTED: (B)(6) 2015. DISCHARGE DIAGNOSIS: SURGICAL WOUND INFECTION SEQUELAE. ESSENTIAL HYPERTENSION. STABLE CORONARY ARTERY DISEASE. HISTORY OF DEPRESSION. HOSPITAL COURSE: ADMITTED SUBSEQUENT TO COMPLAINT OF DISCHARGE AT HER VENTRAL HERNIA REPAIR SURGERY SITE. DR. (B)(6) PUT A JACKSON-PRATT DRAIN IN THE WOUND AND DRAINED THE SUBCUTANEOUS FLUID COLLECTION AT THE SURGERY SITE. THE PLAN IS TO GET HER A WOUND VAC PLACED. DISCHARGING HER TODAY WITH A COURSE OF ANTIBIOTICS FOR SEVEN DAYS. SURGERY RELATED CARE SHOULD BE FOLLOWED UP WITH DR. (B)(6) . SEE PRIMARY CARE PHYSICIAN AS SCHEDULED. ON (B)(6) 2016: (B)(6) HOSPITAL. [SIGNATURE ILLEGIBLE]. ANESTHESIA RECORDS. WEIGHT 135 LB, BMI 25.4. ON (B)(6) 2016: (B)(6) HEALTH SYSTEM. (B)(6) . PATHOLOGY. FINAL DIAGNOSIS: \u00bfABSCESS CAVITY. FIBROADIPOSE TISSUE SHOWING HEMORRHAGE, NECROSIS AND ABSCESS FORMATION. PAS FUNGAL STAIN IS NEGATIVE.\u00bf RELATED MEDICAL DATA: MESH INFECTION. SPECIMEN INFORMATION: ABSCESS CAVITY. GROSS DESCRIPTION: THE SPECIMEN IS LABELED ABSCESS CAVITY. RECEIVED IS AN AGGREGATE OF GRAY-TAN SOFT PERITONEAL TISSUE AND YELLOW ADIPOSE. SPECIMEN MEASURES 6.5 X 5.0 X 1.7 CM. THIS TISSUE IS RAGGED AND ROUGHENED. THERE ARE AREA OF QUESTIONABLE VIABILITY. NO FOCAL LESION IS OBSERVED. AREAS OF THE TISSUE ARE HEMORRHAGIC. CUT SURFACE IS TAN-WHITE AND SMOOTH. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2016: (B)(6) HOSPITAL. LAB. ABDOMINAL MESH- PROTEUS MIRABILIS, STREPTOCOCCUS AGALACTIAE, ENTEROCOCCUS FAECALIS. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6) , MD. CONSULTATION. MANAGEMENT OF CORONARY ARTERY DISEASE AS WELL AS WOUND INFECTION. WHITE CELL COUNT 18.6. SHE DOES NOT SMOKE. IMPRESSION/PLAN: CORONARY ARTERY DISEASE POST BYPASS 8-YEARS AGO. RESTART ASPIRIN. GASTROESOPHAGEAL REFLUX DISEASE, STABLE. ON PROTONIX. HYPERTENSION; CONTINUE LOPRESSOR. HISTORY OF RECENT INFECTION, START ON VANCOMYCIN. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6) , MD, FACS, FASMBS. PROGRESS NOTES. DOING WELL, AMBULATING, TOLERATING LIQUIDS. EXAM: ABDOMEN SOFT, NON-TENDER, NON-DISTENDED. DRESSING CHANGE TODAY. WOUND LOOKS CLEAN. IRRIGATED WITH HYDROGEN PEROXIDE AFTER FOAM PACK WAS REMOVED AND WET TO DRY DRESSING WAS APPLIED. PLAN IS PRIMARY CLOSURE, HYPOMAGNESIUM REPLACED. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6) , MD, FACS, FASMBS. PROGRESS NOTES. DOING WELL, NO COMPLAINTS. EXAM: ABDOMEN SOFT, NON-TENDER, NON-DISTENDED. I CLOSED WOUND TODAY AT BEDSIDE. IMPRESSION/PLAN: WOUND LOOKS EXCELLENT TODAY; NO EVIDENCE OF INFECTION. WOUND AS IRRIGATED WITH BETADINE AND PREVIOUSLY TAKEN AND LEFT UNTIED VERTICAL MATTRESS SUTURES WERE TIED AT BEDSIDE AND STERILE DRESSING WAS APPLIED. TOLERATED PROCEDURE WELL. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6) , MD. PROGRESS NOTES. EXAM: ABDOMEN WITH CENTRAL DRESSING IN PLACE. MILD TENDERNESS. IMPRESSION/PLAN: WOUND INFECTION WITH GRAM NEGATIVE, GROWING POSSIBLE PSEUDOMONAS. CONTINUE ZOSYN, VANCOMYCIN. ON (B)(6) 2016: (B)(6) HOSPITAL. (B)(6) , MD. DISCHARGE SUMMARY. DATE OF ADMISSION: (B)(6) 2016. DISCHARGE DIAGNOSIS: CHRONIC ABDOMINAL WOUND WITH A MESH INVOLVEMENT, STATUS POST HIATAL HERNIA REPAIR AS WELL AS EXPLORATORY LAPAROTOMY. CULTURE IS PROTEUS, WHICH IS EXTENDED-SPECTRUM BETA-LACTAMASES. COURSE OF HOSPITAL: ADMITTED AND OPERATED BY DR. (B)(6) FOR INFECTED MESH AND A HERNIA REPAIR. THE PROCEDURE WENT WELL. WE INITIALLY STARTED HER ON ANTIBIOTICS. CULTURE CAME BACK AS PROTEUS, WHICH IS EXTENDED-SPECTRUM BETA-LACTAMASES SO WE ARE MAKING PLANS FOR HOME HEALTH TO HAVE HER GO THERE TO HER HOUSE AND GIVE ANTIBIOTICS. FOLLOW UP WITH DR. (B)(6) . EXAM: ABDOMEN SOFT, NON-TENDER. NO MASSES. BOWEL SOUNDS PRESENT. A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL." }, { "mdr_text_key": "314995346", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "332280901", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\u00bf THE INSTRUCTIONS FOR USE FURTHER WARN: \u00bfAS WITH ANY IMPLANTABLE SURGICAL DEVICE, STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\u00bf \u00bfWHEN USING THIS DEVICE AS A PERMANENT IMPLANT AND EXPOSURE OCCURS, TREAT TO AVOID CONTAMINATION, OR DEVICE REMOVAL MAY BE NECESSARY.\u00bf PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE PERSISTENT/SYMPTOMATIC SEROMA AND WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE \u00bfD15: CAUSE NOT ESTABLISHED\u00bf IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH.\u00bfTHESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT\u00bfS UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES.THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "324620855", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: MEDICAL HISTORY: SURGICAL HISTORY: (B)(6) 2009: EXPLORATORY LAPAROTOMY. LYSIS OF ADHESIONS FOR 30 MINUTES. OPEN INCISIONAL HERNIA REPAIR WITH MESH. ADVANCEMENT OF CUTANEOUS FLAPS. IMPLANT: GORE-TEX\u00ae SOFT TISSUE PATCH. (B)(6) 2013: ABDOMINAL WALL EXPLORATION, REMOVAL OF PORTION OF MESH, WITH DRAINAGE OF ABDOMINAL WALL ABSCESS AND INTRA-ABDOMINAL ABSCESS. (B)(6) 2013: EXPLORATORY LAPAROTOMY. EXTENSIVE LYSIS OF ADHESIONS, ONE HOUR. REMOVAL OF INFECTED MESH. PARTIAL OMENTECTOMY. ABDOMINAL WASHOUT. ADVANCEMENT OF CUTANEOUS FLAPS. ABDOMINAL CLOSURE. (B)(6) 2013: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH. LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS, 2.5 HOURS. LAPAROSCOPIC DRAINAGE OF ABDOMINAL WALL SEROMA. IMPLANT: GORE\u00ae DUALMESH\u00ae BIOMATERIAL. (B)(6) 2015: EXCISION OF ELLIPTICAL SKIN AND SUBCUTANEOUS TISSUE AND SINUS TRACT OF THE ABSCESS. DRAINAGE OF ABDOMINAL WALL AND INTRAABDOMINAL ABSCESS. PARTIAL MESH EXCISION. (B)(6) 2016: LAPAROTOMY. REMOVAL OF INFECTED MESH. ADVANCEMENT OF MYOCUTANEOUS FLAPS. INCISIONAL HERNIA REPAIR. EXTENSIVE LYSIS OF ADHESIONS X1 HOUR. CLOSURE WITH RETENTION SUTURES. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2009: (B)(6) HOSPITALS. (B)(6) MD. INDICATIONS: \u00bf\u00bf WHO HAD A PREVIOUS INCISIONAL HERNIA REPAIR ABOUT A YEAR AGO WITH SURGISIS MESH. THE PATIENT PRESENTED TO THE CLINIC WITH RECURRENCE THAT WAS CONFIRMED ON A CT SCAN, WITH NO INCARCERATION OR STRANGULATION. THE PATIENT WAS SCHEDULED FOR RECURRENT OPEN INCISIONAL HERNIA REPAIR.\u00bf IMPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY. LYSIS OF ADHESIONS FOR 30 MINUTES. OPEN INCISIONAL HERNIA REPAIR WITH MESH. ADVANCEMENT OF CUTANEOUS FLAPS. IMPLANT: GORE-TEX\u00ae SOFT TISSUE PATCH [1320030020/06746265, 20CM X 30CM X 2CM] IMPLANT #1 DATE: NOVEMBER 17, 2009 (HOSPITALIZATION DATES UNKNOWN) (B)(6) 2009: (B)(6) HOSPITALS. (B)(6) MD. ASSISTANTS: (B)(6) MD/FORREST OLGERS PA-C. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. ANESTHESIA: GENERAL. ESTIMATED BLOOD LOSS: MINIMAL. SPECIMENS: HERNIA SAC AND PART OF OLD MESH SENT TO PATHOLOGY. PROCEDURE: \u00bfA MIDLINE INCISION WAS MADE USING A 10 BLADE SCALPEL. THE INCISION WAS DEEPENED THROUGH SUBCUTANEOUS TISSUE USING ELECTROCAUTERY. BLUNT DISSECTION WAS DONE IN THE SUBCUTANEOUS PLANE TO AVOID ANY INJURY OF THE HERNIA CONTENT. LYSIS OF ADHESIONS WAS THEN DONE BETWEEN THE OMENTUM AND THE ABDOMINAL WALL, AND THE HERNIA SAC WAS EXCISED. ALSO, BETWEEN THE BOWEL AND THE ABDOMINAL WALL. LYSIS OF ADHESIONS LASTED FOR 30 MINUTES. AFTER THE ABDOMINAL CAVITY WAS ENTERED, THE BOWEL WAS EXAMINED. THIS DID NOT SHOW ANY ABNORMALITY, NO ENTEROTOMIES. PART OF THE OLD SURGISIS MESH WAS EXCISED AND SENT TO PATHOLOGY. THE HERNIA DEFECT MEASURED ABOUT 10 X 15 CM. WE THEN PROCEEDED WITH REPAIR OF THE HERNIA USING A GORE SOFT TISSUE PATCH, 20 X 25 CM. THIS WAS PLACED IN UNDERLAY FASHION AND SECURED TO THE FASCIA USING #0 GORE SUTURES IN INTERRUPTED FASHION, OBTAINING AT LEAST 4 CM CIRCUMFERENTIAL MARGIN. THIS WAS DONE AFTER ADVANCEMENT CUTANEOUS FLAPS WERE PERFORMED BY MOBILIZING THE SKIN AND SUBCUTANEOUS TISSUE OFF THE FASCIA BILATERALLY TO ALLOW APPROXIMATION OF THE FASCIA AND DECREASE THE TENSION ON THE REPAIR. THIS WAS DONE USING ELECTROCAUTERY. HEMOSTASIS WAS ACHIEVED THROUGHOUT THE PROCEDURE. BETADINE IRRIGATION WAS DONE AS WELL AS SALINE IRRIGATION. A 19-FRENCH ROUND BLAKE DRAIN WAS THEN PLACED IN THE SUBCUTANEOUS TISSUE AND THEN BROUGHT OUT THROUGH A SEPARATE STAB INCISION AND SECURED TO THE SKIN USING 2-0 NYLON SUTURE. THE SUBCUTANEOUS TISSUE WAS THEN CLOSED USING 3-0 VICRYL SUTURE IN INTERRUPTED FASHION AND THE SKIN WAS CLOSED USING 2-0 NYLON SUTURE IN INTERRUPTED VERTICAL MATTRESS FASHION. THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS OCCURRED DURING THE OPERATION. AT THE END OF THE PROCEDURE, COUNTS OF SPONGE AND NEEDLE WERE ALL CORRECT. THE PATIENT WAS EXTUBATED AND TRANSFERRED TO PACU IN STABLE CONDITION.\u00bf (B)(6) 2009: (B)(6) HOSPITALS. IMPLANT LOG: INVENTORY ITEM: \u00bfPATCH SOFT TISSUE 20CM 1320030020.\u00bf IMPLANT NAME: \u00bfPATCH SOFT TISSUE 20 X 30CM 2CM THICK 1320030020 - LOG25693.\u00bf MODEL/CAT NO.: 1320030020. LOT NUMBER: 06746265. AREA: ABDOMEN. NUMBER USED: 1. MANUFACTURER: WL GORE & ASSOCIATES. EXPIRATION DATE: 5/27/2014. RELEVANT MEDICAL INFORMATION: NO INFORMATION. REVISION #1 PREOPERATIVE COMPLAINTS: (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH THE HISTORY OF INCISIONAL HERNIA REPAIR PRESENTED WITH ABDOMINAL PAIN, FEVER AND FATIGUE. CT SCAN SHOWED A FLUID COLLECTION ABOVE AND BELOW THE MESH AND THE PATIENT WAS DIAGNOSED WITH MESH INFECTION AND SCHEDULED FOR EXPLORATION.\u00bf REVISION #1 PROCEDURE: ABDOMINAL WALL EXPLORATION, REMOVAL OF PORTION OF MESH, WITH DRAINAGE OF ABDOMINAL WALL ABSCESS AND INTRA-ABDOMINAL ABSCESS. REVISION #1 DATE: (B)(6), 2013 (HOSPITALIZATION DATES UNKNOWN) (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: ABDOMINAL PAIN, MESH INFECTION. ANESTHESIA: GENERAL AND LOCAL. ESTIMATED BLOOD LOSS: MINIMAL. SPECIMENS: CULTURE AND SENSITIVITY OF ABSCESS, PART OF MESH FOR CULTURE AND SENSITIVITY. PROCEDURE: \u00bfAFTER GENERAL ANESTHESIA WAS INDUCED AN INCISION WAS MADE IN THE MIDLINE USING A I0 BLADE SCALPEL. THERE WAS A SMALL ABSCESS IN THE SUBCUTANEOUS TISSUE AND THIS WAS DRAINED AND SENT FOR CULTURE AND SENSITIVITY. THERE WAS NO RECURRENCE OF THE HERNIA. THE MESH WAS IDENTIFIED. THERE WAS A BULGE BELOW THE MESH. AFTER COPIOUS IRRIGATION OF THE SKIN AND SUBCUTANEOUS TISSUE WAS DONE WITH SALINE MIXED WITH VANCOMYCIN A SMALL INCISION WAS THEN MADE IN THE MESH AND THE INTRA-ABDOMINAL ABSCESS BELOW THE MESH WAS DRAINED. THERE WAS ALSO A SMALL ABSCESS THAT WAS NOT FREE IN THE ABDOMINAL CAVITY. THIS WAS LOCALIZED IN THE AREA BELOW THE MESH. THERE WAS NO OTHER PATHOLOGY IDENTIFIED. PART OF THE REDUNDANT MESH WAS REMOVED. COPIOUS IRRIGATION WAS DONE USING VANCOMYCIN AND SALINE. THE MESH WAS THEN CLOSED LEAVING A SMALL OPENING IN THE MESH TO DRAIN ANY COLLECTION BELOW THE MESH AND A 10 FRENCH FLAT JP DRAIN WAS THEN PLACED ON TOP OF THE MESH AND BROUGHT OUT THROUGH A SEPARATE STAB INCISION TO THE LEFT OF THE WOUND AND SECURED TO THE SKIN USING A 2-0 NYLON SUTURE. THE PLAN IS TO TRY TO PRESERVE THE MESH. COPIOUS IRRIGATION WAS THEN AGAIN PERFORMED AND THE SKIN WAS LEFT OPEN AND THE INTERRUPTED VERTICAL MATTRESS 2-0 NYLON SUTURES WERE TAKEN AND LEFT UNTIED FOR DELAYED PRIMARY CLOSURE. IODOFORM PACK WAS PLACED. THE SUTURES USED FOR THE MESH WERE 2-0 PROLENE. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED DURING THE OPERATION. BY THE END OF THE PROCEDURE THE COUNT, SPONGE AND NEEDLE WERE ALL CORRECT.\u00bf EXPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH HISTORY OF VENTRAL HERNIA REPAIR, WHO DEVELOPED MESH INFECTION. ATTEMPT SALVAGE THE MESH WERE NOT SUCCESSFUL AND THE PATIENT WAS SUBSEQUENTLY SCHEDULED FOR REMOVAL OF THE MESH.\u00bf EXPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY. EXTENSIVE LYSIS OF ADHESIONS, ONE HOUR. REMOVAL OF INFECTED MESH. PARTIAL OMENTECTOMY. ABDOMINAL WASHOUT. ADVANCEMENT OF CUTANEOUS FLAPS. ABDOMINAL CLOSURE. EXPLANT #1 DATE: (B)(6), 2013 (HOSPITALIZATION DATES UNKNOWN) (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: ABDOMINAL PAIN, INFECTED MESH. ANESTHESIA: GENERAL AND LOCAL. ESTIMATED BLOOD LOSS: MINIMAL. PROCEDURE: \u00bfMIDLINE LAPAROTOMY INCISION WAS MADE USING 10-BLADE SCALPEL AND INCISION WAS DEEPENED THROUGH THE SUBCUTANEOUS TISSUES WITH ELECTROCAUTERY. INCISION EXTENDED FROM THE XIPHOID TO THE INFRAUMBILICAL REGION. THE ABDOMINAL CAVITY WAS ENTERED WITHOUT INJURY. LYSIS OF ADHESIONS WAS DONE, FREEING THE OMENTUM FROM THE ABDOMINAL WALL. THIS WAS THEN CARRIED ALL THE WAY DOWN TO THE MESH. THERE WAS EXTENSIVE SCARRING AND ADHESIONS IN THIS AREA AND LYSIS OF ADHESIONS WAS DONE FOR ABOUT ONE HOUR UNTIL THE MESH WAS COMPLETELY REMOVED. THE SUTURES WERE CUT AND THERE WAS NO EVIDENCE OF ABSCESS. THE MESH WAS SEVERELY ADHERENT TO THE ABDOMINAL WALL IN THE OMENTUM AND THIS WAS FREED USING GENTLE BLUNT DISSECTION AS WELL AS SHARP DISSECTION WITH METZ AND ALSO ELECTROCAUTERY. NO INJURY WAS ENCOUNTERED. THE MESH WAS THEN SENT FOR CULTURES AND GROSS EXAMINATION. THE CAPSULE UNDER THE MESH WHICH FORMED THE WALL OF THE ABSCESS CAVITY THAT WAS DRAINED IN THE LAST SURGERY WAS ALSO EXCISED OFF THE OMENTUM AND ALSO SENT TO PATHOLOGY WITH A PORTION OF THE OMENTUM. A SMALL DEFECT AT THE OMENTUM AFTER THE PARTIAL OMENTECTOMY WAS THEN CLOSED USING #2-0 VICRYL SUTURE IN PURSE STRING FASHION TO AVOID INTERNAL HERNIA. AFTER THE INFECTED TISSUE WAS REMOVED, GLOVES AND INSTRUMENTS WERE CHANGED AND COPIOUS IRRIGATION OF THE ABDOMINAL CAVITY WITH SALINE WAS DONE. EXPLORATORY LAPAROTOMY SHOWED NO OTHER PATHOLOGY. THE SMALL BOWEL WAS RUN FROM THE LIGAMENT OF TREITZ TO THE ILEOCECAL VALVE. THE COLON WAS INSPECTED. THE LIVER WAS PALPATED AND NO NODULES WERE FELT. NO PATHOLOGY WAS IDENTIFIED IN THE STOMACH OR OTHER ABDOMINAL ORGANS. EXPLORATORY LAPAROTOMY WAS OTHERWISE NEGATIVE. AFTER ABDOMINAL WASHOUT WAS DONE WE THEN PROCEEDED WITH ADVANCEMENT OF CUTANEOUS FLAPS TO CLOSE THE FASCIA IN THE MIDLINE. SKIN AND SUBCUTANEOUS TISSUE WERE MOBILIZED OF THE FASCIA BILATERALLY USING ELECTROCAUTERY AS WELL AS BLUNT DISSECTION. PERFORATORS WERE CONTROLLED USING ELECTROCAUTERY AND #3 AND #2-0 VICRYL TIES. HEMOSTASIS WAS ACHIEVED. MOBILIZATION WAS DONE BILATERALLY, APPROXIMATING THE FASCIA IN THE MIDLINE. THIS WAS DONE ALL THE WAY LATERAL TO THE MID CLAVICULAR LINE. THERE WAS NO COMPROMISE OF THE BLOOD SUPPLY OF THE SKIN. THE FASCIA REACHED THE MIDLINE WITH NO TENSION. THE FASCIA WAS THEN CLOSED USING #0-VICRYL SUTURE IN INTERRUPTED FIGURE-OF-EIGHT FASHION. SUBCUTANEOUS TISSUE WAS THEN COPIOUSLY IRRIGATED AND THEN WAS PACKED WITH LODOFORM PACK AND THE SKIN AND SUB-CU WERE LEFT OPEN FOR DELAYED PRIMARY CLOSURE. #2-0 NYLON SUTURES WERE TAKEN IN VERTICAL MATTRESS FASHION AND LEFT UNTIED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS OCCURRED DURING THE OPERATION. AT THE END OF THE PROCEDURE THE COUNT OF SPONGE AND NEEDLE WERE ALL CORRECT. THE PATIENT WAS THEN EXTUBATED AND TRANSFERRED TO PACU IN STABLE CONDITION. FORREST OLGERS, PA-C, ASSISTED ME THROUGHOUT THE PROCEDURE WITH RETRACTION, EXPOSURE, REMOVAL OF MESH AND CLOSING THE ABDOMEN.\u00bf (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), MD. PATHOLOGY. SPECIMENS RECEIVED: ABSCESS WALL WITH OMENTUM AND MESH FOR GROSS EXAM AND CULTURE. FINAL PATHOLOGIC DIAGNOSIS: PORTION OF OMENTAL TISSUE WITH MARKED REACTIVE FIBROSIS AND GRANULATION TISSUE. MESH MATERIAL WITH ASSOCIATED REACTIVE FIBROSIS. GROSS DESCRIPTION: PART A: \u00bfABSCESS WALL WITH OMENTUM\u00bf. IT CONSISTS OF A 5.0 X 4.0 X 1.2 CM TAN-BROWN, FOCALLY NECROTIC, MEMBRANOUS TISSUE, AND A 5.0 X 5.0 X 0.5 CM YELLOW-TAN, LOBULATED FIBROADIPOSE TISSUE. PART B: \"MESH FOR GROSS EXAM AND CULTURE\". IT CONSISTS OF A 12.0 X 8.5 X 0.3 CM TAN-PINK FLAT MATERIAL, WITH ATTACHED 1.8 X 1.6 X 1.0 CM TAN-BROWN, SOFT TISSUE.\u00bf RELEVANT MEDICAL INFORMATION: NO INFORMATION. IMPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH HISTORY OF MULTIPLE INCISIONAL HERNIAS. THE LAST REPAIR WAS DONE PRIMARILY AFTER INFECTED MESH WAS REMOVED. THE PATIENT WAS SUBSEQUENTLY DOING WELL UNTIL SHE WAS HAVING CARDIAC CATHETERIZATION AND THE PATIENT STATED THAT AFTER THE PROCEDURE SHE DEVELOPED RECURRENCE OF THE HERNIA. PLEASE REFER TO THE PATIENT'S CLINIC NOTES FOR DETAILS. THE PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND WAS SCHEDULED FOR LAPAROSCOPIC REPAIR.\u00bf IMPLANT #2 PROCEDURE: LAPAROSCOPIC REPAIR OF RECURRENT INCARCERATED INCISIONAL HERNIA WITH MESH. LAPAROSCOPIC EXTENSIVE LYSIS OF ADHESIONS, 2.5 HOURS. LAPAROSCOPIC DRAINAGE OF ABDOMINAL WALL SEROMA. IMPLANT: GORE\u00ae DUALMESH\u00ae BIOMATERIAL [1DLMC04/10364142, 25 CM X 19CM]. IMPLANT #2 DATE: (B)(6) 2013 (HOSPITALIZATION JUNE 4-5, 2013) (B)(6) 2013: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA; EXTENSIVE INTRAABDOMINAL ADHESIONS WITH INCARCERATION OF SMALL BOWEL, LARGE BOWEL AND OMENTUM. ANESTHESIA: GENERAL AND LOCAL. SPECIMENS: HERNIA SAC FOR GROSS EXAMINATION ONLY. FINDINGS: \u00bfEXTENSIVE INTRAABDOMINAL ADHESIONS WITH INCARCERATED SMALL AND LARGE BOWEL AND OMENTUM. SEROMA IN THE HERNIA SAC. HERNIA DEFECT WAS 11 X 7 CM.\u00bf PROCEDURE: \u00bfTHE PATIENT HAS A HISTORY OF RECENT CARDIAC STENT AND, AFTER EXTENSIVE DISCUSSION WITH THE PATIENT AND HUSBAND AND WEIGHING THEIR RISKS VS. BENEFITS, DECISION WAS MADE TO KEEP HER ON PLAVIX INTRAOPERATIVELY TO AVOID THE RISK OF STENT OCCLUSION OR ANY ADVERSE CARDIAC EVENT. A FOLEY CATHETER WAS PLACED. PNEUMOPERITONEUM WAS ACHIEVED VIA 5 MM VISIPORT TECHNIQUE IN THE LEFT UPPER QUADRANT AT THE AXILLARY LINE UNDER DIRECT VISUALIZATION WITH 5 MM FLEX TIPPED SCOPE. NO INJURY OCCURRED FROM ACCESS. PNEUMOPERITONEUM WAS ACHIEVED TO 15 MMHG. ALL THE OTHER PORTS WERE DILATING VERSASTEP PORTS. THE SKIN WAS INFILTRATED WITH 1% LIDOCAINE PLAIN AND 0.5% MARCAINE PLAIN MIXED 1:1 BEFORE ANY SKIN INCISION. PORTS WERE THEN PLACED UNDER VISION. WE STARTED WITH 5 MM DILATING VERSASTEP PORT IN THE LEFT LOWER QUADRANT AT THE AXILLARY LINE. THERE WERE EXTENSIVE ADHESIONS NOTED IN THE ABDOMEN. THERE WERE EXTENSIVE OMENTAL ADHESIONS WITH THE ABDOMINAL WALL, AS WELL AS ADHESIONS BETWEEN THE SMALL AND LARGE BOWEL AND THE TRANSVERSE COLON THAT WAS ALSO ADHERENT INSIDE THE HERNIA AND ALSO SMALL BOWEL LOOPS THAT WERE ADHERENT AND INCARCERATED IN THE HERNIA DEFECT AND TO THE ABDOMINAL WALL. WE STARTED WITH LAPAROSCOPIC LYSIS OF ADHESIONS USING LAPAROSCOPIC SCISSORS, FREEING THE OMENTUM IN THE LOWER ABDOMEN. ANOTHER 5 MM PORT WAS THEN PLACED IN THE SUPRAPUBIC REGION UNDER DIRECT VISION. WE THEN PROCEEDED WITH LYSIS OF ADHESIONS IN THE RIGHT ABDOMEN. AS MENTIONED, THE ADHESIONS WERE EXTENSIVE IN THE ABDOMEN SECONDARY TO THE PATIENT'S MULTIPLE PREVIOUS LAPAROTOMIES. GENTLE BLUNT ADHESION LYSIS WAS DONE, AS WELL AS SHARP DISSECTION WITH LAPAROSCOPIC SCISSORS AND ELECTROCAUTERY FOR FLESHY ADHESIONS, WITHOUT INJURY TO THE BOWEL. NO ENTEROTOMIES WERE ENCOUNTERED. THE HERNIA DEFECT WAS LARGE AND THERE WAS TRANSVERSE COLON, AS WELL AS SMALL BOWEL AND OMENTUM, INCARCERATED IN THE HERNIA SAC. METICULOUS DISSECTION WAS DONE, FREEING ALL THE BOWEL LOOPS INTO THE ABDOMINAL CAVITY ALONG AVASCULAR PLANES. NO INJURY OCCURRED. THE ADHESIONS INVOLVE THE ENTIRE ABDOMEN. WE PLACED ONE PORT AT A TIME AFTER FREEING SOME ADHESIONS. AT THE END, A TOTAL OF FIVE PORTS WERE PLACED, THE THREE PORTS MENTIONED EARLIER IN THE DICTATION, AND THEN ANOTHER 12 MM PORT IN THE RIGHT UPPER QUADRANT AT THE AXILLARY LINE AND 5 MM PORT IN THE RIGHT LOWER QUADRANT AT THE AXILLARY LINE. LYSIS OF ADHESIONS LASTED FOR 2.5 HOURS AND THIS, IN ADDITION TO THE PATIENT BEING ON PLAVIX TO PROTECT HER CARDIAC STENT, ADDED TECHNICAL DIFFICULTIES TO THE PROCEDURE. HEMOSTASIS WAS ACHIEVED THROUGHOUT THE PROCEDURE WITH ELECTROCAUTERY, AS WELL AS SURGISEAL AND FLOSEAL AND 5 MM CLIPS. OVERALL, THE BLOOD LOSS WAS MINIMAL. AFTER LYSIS OF ADHESIONS WAS PERFORMED, THE HERNIA WAS MEASURED AND THIS WAS FOUND TO BE 11 CM LONGITUDINALLY BY 7 CM TRANSVERSELY. THERE WAS A SEROMA IN THE HERNIA SAC AND THE SEROMA WAS OPENED USING LAPAROSCOPIC SCISSORS WITH ELECTROCAUTERY AND DRAINED INTO THE PERITONEAL CAVITY. THE HERNIA SAC WAS THICK AND THIS WAS EXCISED USING SCISSORS AND SENT TO PATHOLOGY FOR GROSS EXAMINATION ONLY. WE THEN PROCEEDED WITH REPAIR OF THE HERNIA. THE PATIENT WAS EVALUATED BY DR. SEYOUM BAGE AND WAS CLEARED FOR MESH PLACEMENT. I ALSO CONFIRMED THAT TODAY WITH DR. BAGE OVER THE PHONE BEFORE PLACEMENT OF THE MESH AND I EXPLAINED TO HIM THE OPERATIVE FINDINGS. THERE WAS NO EVIDENCE OF INFECTION OR ABSCESS. AFTER MY DISCUSSION WITH DR. BAGE, THE PATIENT WAS ASSESSED TO BE CLEAR FOR PLACEMENT OF NON-ABSORBABLE MESH TO MINIMIZE THE RISK OF RECURRENCE, AS SHE HAS LOW RISK OF INFECTION OF THE MESH. A GORE DUAL MESH WAS USED TO REPAIR THE HERNIA. THIS WAS A 19 X 15 CM MESH OBTAINING 4 CM CIRCUMFERENTIAL MARGIN. THE MESH WAS SECURED IN PLACE USING #0 GORE TRANSFASCIAL FIXING SUTURES AND PRO TACKS. AFTER PERFORMING THE REPAIR, LAPAROSCOPIC EXAMINATION OF THE ABDOMEN CONFIRMED THAT THE MESH WAS PROPERLY PLACED. THERE WAS NO EVIDENCE OF INJURY. THERE WAS NO EVIDENCE OF BLEEDING OR INTRAABDOMINAL COMPLICATIONS. PNEUMOPERITONEUM WAS THEN DESUFFLATED UNDER DIRECT VISION AND PORTS WERE REMOVED. THE INCISIONS WERE CLOSED USING 4-0 MONOCRYL SUTURE IN SUBCUTICULAR FASHION AND LIQUIBAND. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED DURING THE OPERATION.\u00bf (B)(6) 2013: (B)(6) HOSPITAL. IMPLANT LOG: \u00bfGORE DUAL MESH\u00bf. MODEL#: 1DLMC04. LOT#: 10364142. SIZE: \u00bf15 X 19 X 1 CM\u00bf. EXPIRATION DATE: 2017-04. SITE: INTRABDOMINAL. (B)(6) 2013: (B)(6) HOSPITALS, INC. (B)(6), MD. PATHOLOGY. SPECIMEN: HERNIA SAC. GROSS DESCRIPTION: \u00bfIT CONSISTS OF A 5.5 X 5.0 X 0.9 CM PIECE OF SMOOTH, TAN, GLISTENING TISSUE WITH CAUTERIZED AREAS.\u00bf PARTIAL EXPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) MD. INDICATION: \u00bf\u00bf WITH HISTORY OF LAPAROSCOPIC INCISIONAL HERNIA REPAIR APPROXIMATELY TWO YEARS AGO. THE PATIENT HAD MULTIPLE ABDOMINAL SURGERIES AND HISTORY OF MRSA INFECTIONS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AT CAMDEN-CLARK YESTERDAY, HAD A CT SCAN, AND WAS FOUND TO HAVE FLUID COLLECTION ABOVE AND BELOW THE MESH. SHE HAS INTERMITTENT SINUS DRAINAGE FROM THE ABDOMINAL WALL IN THE SUPRAUMBILICAL AREA FOR THE PAST FOUR WEEKS THAT HAS BEEN PROGRESSIVELY GETTING WORSE. SHE HAD CHILLS; DENIES FEVER. SHE HAS ABDOMINAL PAIN. THE PATIENT WAS TRANSFERRED TO PRESTON MEMORIAL HOSPITAL AND WAS SEEN. EVALUATED, AND TAKEN TO THE OPERATING ROOM FOR DRAINAGE OF THE ABSCESS. I DISCUSSED WITH THE PATIENT IN DETAIL THAT WE WILL ATTEMPT TO SALVAGE THE MESH AND SHE WAS AGREEABLE TO THE PLAN.\u00bf PARTIAL EXPLANT #2 PROCEDURE: EXCISION OF ELLIPTICAL SKIN AND SUBCUTANEOUS TISSUE AND SINUS TRACT OF THE ABSCESS. DRAINAGE OF ABDOMINAL WALL AND INTRAABDOMINAL ABSCESS. PARTIAL MESH EXCISION. PARTIAL EXPLANT #2 DATE: (B)(6), 2015 (HOSPITALIZATION (B)(6) 2015) (B)(6) 2015: (B)(6) HOSPITAL. (B)(6) MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: ABDOMINAL WALL ABSCESS, INTRAABDOMINAL ABSCESS AND ABDOMINAL PAIN. ANESTHESIA: GENERAL AND LOCAL. SPECIMENS: CULTURE AND SENSITIVITY FROM THE ABSCESS, AEROBIC AND ANAEROBIC. PORTION OF MESH FOR CULTURE. SKIN AND SUBCUTANEOUS TISSUE WITH SINUS TRACT TO PATHOLOGY. PROCEDURE: \u00bfAFTER GENERAL ANESTHESIA WAS INDUCED, THE SINUS TRACT WAS IN THE MIDLINE, MIDWAY BETWEEN THE XIPHOID AND THE UMBILICUS. AN ELLIPTICAL INCISION WAS MADE SURROUNDING THE TRACT AND THE INDURATED SKIN USING A 10-BLADE SCALPEL. INCISION WAS DEEPENED THROUGH THE SUBCUTANEOUS TISSUES WITH ELECTROCAUTERY. THE FASCIA WAS IDENTIFIED. THERE WAS A SUPERFICIAL ABSCESS POCKET ABOVE THE MESH AND THIS WAS SENT FOR CULTURE AND SENSITIVITY AND WAS DRAINED. THE SKIN AND SUBCUTANEOUS TISSUE, INCLUDING THE SINUS TRACT AND ABSCESS CAVITY, WAS REMOVED AND SENT TO PATHOLOGY. THE MESH WAS IDENTIFIED. THE MESH WAS INTACT. THERE WAS NO EVIDENCE OF RECURRENCE OF THE HERNIA. THERE WERE NO OTHER POCKETS ABOVE THE MESH. I THEN PROCEEDED WITH MAKING A SMALL INCISION IN THE MESH AND IMMEDIATELY THERE WAS A GUSH OF PUS. THERE WAS NO EVIDENCE OF STOOLS OR ANY ENTERIC CONTENTS. THERE WAS NO EVIDENCE OF ENTERIC OR COLONIC FISTULAS. THE PUS WAS SENT FOR CULTURE AND WAS EVACUATED. THIS WAS LOCALIZED AND ENCAPSULATED UNDER THE MESH WITH NO EVIDENCE OF SPREAD INTO THE FREE PERITONEAL CAVITY. I THEN PROCEEDED WITH IRRIGATION OF THE ABSCESS CAVITIES WITH HYDROGEN PEROXIDE. THEY WERE THEN IRRIGATED WITH BETADINE AND COPIOUS IRRIGATION WITH SALINE. AN 8-FRENCH JP DRAIN WAS THEN PLACED IN THE ABSCESS CAVITY BELOW THE MESH AND PART OF THE MESH WAS EXCISED AND REMOVED AND SENT FOR CULTURE TO REDUCE REDUNDANCY OF MESH IN THIS AREA AND DECREASE POTENTIAL SPACE FOR FLUID ACCUMULATION. THE MESH WAS THEN CLOSED USING 2-0 PROLENE IN A RUNNING FASHION. THE WOUND WAS AGAIN IRRIGATED AND HEMOSTASIS WAS ACHIEVED AND 1-INCH IODOFORM PACK WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED DURING THE OPERATION. AT THE END OF THE PROCEDURE, THE COUNT OF SPONGE AND NEEDLE WERE ALL CORRECT. THE PATIENT WAS THEN EXTUBATED AND TRANSFERRED TO PACU IN STABLE CONDITION.\u00bf \u00bfPLAN WILL BE TO CONTINUE ANTIBIOTICS AND WET-TO-DRY DRESSING B.I.D. THE PATIENT WILL GO HOME WITH A JP DRAIN AND SHE WILL RECEIVE JP MANAGEMENT TEACHING BEFORE DISCHARGE AND WE WILL PLAN FOR VANC DRESSING AT HOME.\u00bf (B)(6) 2015: (B)(6) HOSPITAL. (B)(6), PA/(B)(6), MD. PATHOLOGY. SPECIMENS RECEIVED: A. SKIN WITH SUBCUTANEOUS TISSUE WITH SINUS TRACT. FINAL PATHOLOGIC DIAGNOSIS: SKIN WITH SINUS TRACT, GRANULOMATOUS TISSUE, FIBROSIS, AND INFLAMMATION. GROSS DESCRIPTION: PART A SEATED FORMALIN LABELED \"BACKUS, CONNIE\" AND \"SKIN WITH SUBCUTANEOUS TISSUE WITH SINUS TRACT\u00bf- IT CONSISTS OF 5.7 X 1.9 CM ELLIPSE OF TAN SKIN EXCISED TO A DEPTH OF 1.7 CM. THE SKIN SURFACE CONTAINS A 0.5 X 0.3 CM SHALLOW DEPRESSION WITH A PITTED CENTER THAT IS 0.7 CM FROM THE CLOSEST PERIPHERAL SKIN MARGIN. THE CENTER IS PROBED AND COMMUNICATES WITH A SINUS TRACT THAT EXTENDS TO THE DEEP MARGIN. THE ATTACHED SUBCUTANEOUS TISSUE IS COMPOSED OF YELLOW, LOBULATED ADIPOSE T ISSUE WITH A FIRM YELLOW-TAN AREA OF EXUDATE AT THE DEEP MARGIN. THE SPECIMEN IS SERIALLY SECTIONED TO REVEAL A PATENT SINUS TRACT AND A CUT SURFACE THAT IS A DULL YELLOW-ORANGE AND TAN. THE REMAINDER OF THE SPECIMEN DISPLAYS A FIRM, FIBROUS, CENTRALLY LOCATED TAN-GRAY CUT SURFACE THAT COMMUNICATES WITH THE DEEP MARGIN ALONG THE ENTIRE LENGTH OF THE SPECIMEN AND IS SURROUNDED BY SOFT, YELLOW LOBULATED ADIPOSE TISSUE.\u00bf EXPLANT #2 PREOPERATIVE COMPLAINTS: (B)(6) 2016: (B)(6) HOSPITAL. (B)(6). INDICATION: \u00bf\u00bf WITH HISTORY OF MULTIPLE VENTRAL HERNIA REPAIRS. THE PATIENT HAS A HISTORY OF INCISIONAL HERNIA THAT WAS REPAIRED WITH GORE DUAL MESH AND THE PATIENT HAS RECURRENT HISTORY OF MESH INFECTIONS. SHE DEVELOPED MESH INFECTION WITH ATTEMPT TO SALVAGE THE MASS IN LATE 2015 WAS NOT SUCCESSFUL. THE PATIENT HAD PURULENT DRAINAGE WITH A SINUS OPENING AT THE LEVEL OF THE UMBILICUS AND THE MESH NEEDED REMOVAL. THE PATIENT WAS SEEN IN THE OFFICE AND SCHEDULED FOR SURGERY.\u00bf EXPLANT #2 PROCEDURE: LAPAROTOMY. REMOVAL OF INFECTED MESH. ADVANCEMENT OF MYOCUTANEOUS FLAPS. INCISIONAL HERNIA REPAIR. EXTENSIVE LYSIS OF ADHESIONS X1 HOUR. CLOSURE WITH RETENTION SUTURES. EXPLANT #2 DATE: (B)(6)2016 (HOSPITALIZATION (B)(6) 2016 \u00bf (B)(6) 2016) (B)(6) 2016: (B)(6) HOSPITAL. (B)(6)MD. ASSISTANT: (B)(6), PA-C. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: INFECTED MESH; HISTORY OF INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: INFECTED MESH; HISTORY OF INCISIONAL HERNIA; PLUS EXTENSIVE INTRAABDOMINAL ADHESIONS. ANESTHESIA: GENERAL AND LOCAL. SPECIMENS: MESH AND ABSCESS CAVITY FOR CULTURE. PROCEDURE: \u00bfAN INCISION WAS MADE IN THE MIDLINE USING 10-BLADE SCALPEL AND DEEP SUBCUTANEOUS TISSUE WITH ELECTROCAUTERY ALONG THE OLD SCAR. THE FASCIA WAS OPENED ABOVE AND BELOW THE HERNIA THAT WAS REPAIRED PREVIOUSLY IN AN UNDERLAY FASHION. THE MESH WAS VISIBLE WITH PUS ABOVE THAT WAS SUCTIONED. THE FASCIA WAS OPENED IN THE MIDLINE AND WE PROCEEDED WITH LYSIS OF ADHESIONS. THIS WAS DONE USING ELECTROCAUTERY, GENTLE BLUNT DISSECTION, AND SCISSORS. THE MESH WAS COMPLETELY REMOVED AND SENT FOR CULTURES. THERE WAS AN ABSCESS CAVITY UNDERNEATH THE MESH AND THIS WAS ADHERENT TO THE BOWEL, AS WELL AS TO THE ABDOMINAL WALL, AND THIS WAS REMOVED USING VERY GENTLE DISSECTION. AS WELL AS METZ. NO BOWEL INJURY OCCURRED. WE THEN PROCEEDED WITH LYSIS OF ADHESIONS OF THE SMALL BOWEL, AS THE BOWEL WAS ADHERENT TO MULTIPLE AREAS INCLUDING INTERLOOP ADHESIONS OF THE ABDOMINAL WALL AND PELVIS. OVERALL LYSIS OF ADHESIONS THROUGHOUT THE PROCEDURE LASTED FOR ONE HOUR. THE ABDOMEN WAS COPIOUSLY IRRIGATED WITH 5 LITERS OF SALINE UNTIL THE RETURN WAS CLEAR AND WE PROCEEDED WITH CLOSURE. PER MY PREVIOUS DISCUSSION WITH THE PATIENT, WE PLAN NO MESH PLACEMENT TODAY AND PLAN MEDIALIZATION OF THE FASCIA WITH ADVANCEMENT OF MYOCUTANEOUS FLAPS. THE SKIN AND SUBCUTANEOUS TISSUE WERE MOBILIZED OVER THE FASCIA BILATERALLY UNTIL THE FASCIA WAS MEDIALIZED AND REACHED THE MIDLINE WITHOUT TENSION. I EXCISED THE SINUS TRACT TO FACILITATE HEALING. THE FASCIA WAS THEN CLOSED USING #1 MAXON LOOP SUTURE IN RUNNING FASHION AND, BECAUSE OF THE HISTORY OF CHRONIC INFECTION AND POSSIBILITY OF DEHISCENCE, I ALSO PLACED A #1 BIOSYN RETENTION SUTURE IN A C-SHAPED FASHION. PLANNING DELAYED PRIMARY CLOSURE OF THE SKIN SO 2-0 NYLON SUTURES IN A VERTICAL MATTRESS FASHION WERE TAKEN AND LEFT UNTIED AND THE WOUND WAS PACKED WITH IODOFORM. BECAUSE OF THE INFECTION, THE UMBILICUS IS LOST. THE PATIENT MIGHT NEED RECONSTRUCTION OF THE UMBILICUS IN THE FUTURE. THIS WAS NOT IDENTIFIED TODAY BEFORE THE SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS OCCURRED DURING THE OPERATION. FOLLOWING THE PROCEDURE, THE COUNT OF SPONGE AND NEEDLE WERE ALL CORRECT. THE PATIENT WAS THEN EXTUBATED AND TRANSFERRED TO PACU IN STABLE CONDITION.\u00bf (B)(6) 2016: (B)(6) HEALTH SYSTEM. PROVIDER NOT LISTED. PATHOLOGY. FINAL DIAGNOSIS: \u00bfABSCESS CAVITY. FIBROADIPOSE TISSUE SHOWING HEMORRHAGE, NECROSIS AND ABSCESS FORMATION. PAS FUNGAL STAIN IS NEGATIVE.\u00bf (B)(6) 2016: (B)(6)HOSPITAL. (B)(6). PATHOLOGY. SPECIMEN: ABSCESS CAVITY. GROSS DESCRIPTION: \u00bfTHE SPECIMEN IS LABELED ABSCESS CAVITY. RECEIVED IS AN AGGREGATE OF GRAY-TAN SOFT PERITONEAL TISSUE AND YELLOW ADIPOSE. SPECIMEN MEASURES 6.5 X 5.0 X 1.7 CM. THE TISSUE IS RAGGED AND ROUGHENED. THERE ARE AREAS OF QUESTIONABLE VIABILITY. NO FOCAL LESION IS OBSERVED. AREAS OF THE TISSUE ARE HEMORRHAGIC. CUT SURFACE IS TAN-WHITE AND SMOOTH.\u00bf A POTENTIAL RELATIONSHIP, IF ANY, BETWEEN THE ALLEGED INJURIES OR COMPLICATIONS AND THE GORE DEVICE HAS NOT BEEN ESTABLISHED AT THIS TIME BASED ON AVAILABLE INFORMATION. \u00a0 IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIALINSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL." }, { "mdr_text_key": "203126658", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "203126659", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE-TEX\u00ae SOFT TISSUE PATCH, AND ON (B)(6) 2013 WHEREBY A GORE\u00ae DUALMESH\u00ae BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, (B)(6) 2015 AND (B)(6) 2016 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED OR PARTIALLY EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FOR THE GORE-TEX\u00ae SOFT TISSUE PATCH; REMOVAL OF INFECTED MESH; RECURRENT INCISIONAL HERNIA; ABSCESS; CHRONIC INFECTION & INFLAMMATION; LYSIS OF ADHESION'S; SEVERE PAIN, THERE WAS A RECURRENT DEFECT BELOW THE GORE MESH. FOR THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL; ((B)(6) 2015) EXCISION OF ELLIPTICAL SKIN AND SUBCUTANEOUS TISSUE AND SINUS TRACT OF THE ABSCESS, DRAINAGE OF ABDOMINAL WALL AND INTRA-ABDOMINAL ABSCESS AND PARTIAL MESH EXCISION, ((B)(6) 2016) REMOVAL OF INFECTED MESH, INCISIONAL HERNIA REPAIR, LYSIS OF ADHESION'S, LAPAROTOMY DUE TO INFECTED MESH, ABSCESS, DRAINAGE OF SINUS TRACT AND ABSCESS CAVITY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "P.O. BOX 1408", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86004", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/11/2020;12/11/2020;02/03/2021;03/12/2021;12/14/2022" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-07279", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20191217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200901", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201005", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200901", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10479485", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200811", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205190316", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES OF DEATH, EVENT, AND IMPLANT: DATES ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S. THE XIENCE DEVICE AND THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS." }, { "mdr_text_key": "205190317", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A RESEARCH ARTICLE THAT ABSORB AND XIENCE STENTS MAY BE RELATED TO DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS, AND REVASCULARIZATION. RESULTS WERE ASSESSED AT A 5 YEAR FOLLOW UP. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE IN THE ATTACHED ARTICLE NAMED \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-07280", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20191217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "951", "date_added": "20200901", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201001", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200901", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10479528", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200811", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "205281965", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S. THE XIENCE DEVICE AND THE ADDITIONAL ADVERSE PATIENT EFFECT OF DEATH REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS. LITERATURE ATTACHMENT. ARTICLE TITLE \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"NA." }, { "mdr_text_key": "205281966", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED IN A RESEARCH ARTICLE THAT ABSORB AND XIENCE STENTS MAY BE RELATED TO DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS, AND REVASCULARIZATION. RESULTS WERE ASSESSED AT A 5 YEAR FOLLOW UP. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE IN THE ATTACHED ARTICLE NAMED \"VERY LONG-TERM OUTCOME OF ABSORB BIORESORBABLE VASCULAR SCAFFOLD VS. EVEROLIMUS-ELUTING METALLIC STENT IN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION: 5-YEAR RESULTS OF THE BVS-EXAMINATION STUDY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FLAGSTAFF", "manufacturer_contact_address_1": "1505 N. FOURTH STREET", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "2017233-2020-01199", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "K963619", "date_of_event": "20000414", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "86004", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "WOMBLE", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "86005", "manufacturer_g1_state": "AZ", "reporter_country_code": "US", "manufacturer_contact_area_code": "928", "date_added": "20200901", "manufacturer_contact_f_name": "HEIDI", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "GORE-TEX\u00ae SOFT TISSUE PATCH", "generic_name": "MESH, SURGICAL, POLYMERIC", "manufacturer_d_name": "W. L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "1505 N. FOURTH STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86004", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86004", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FTL", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Mesh, Surgical, Polymeric", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/14/2020;03/05/2021;03/05/2021", "manufacturer_contact_country": "US", "date_changed": "20240206", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "42 YR", "patient_sex": "Male", "patient_weight": "77 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20230313", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "10480104", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200814", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "86005", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL WOODY MOUNTAIN B/P", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "324932452", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. IT SHOULD BE NOTED THAT THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" \u00a0 THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "334642079", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INVESTIGATION HAS BEEN COMPLETED.\u00bf BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. IN THE ABSENCE OF ADDITIONAL INFORMATION OR MEDICAL RECORDS FROM THE COMPLAINANT, THIS EVENT FILE WILL BE CLOSED WITH THE INFORMATION PROVIDED. \u00bf IT SHOULD BE NOTED THAT THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE COMPLICATIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS: COMPLICATIONS WHICH MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO: INFECTION, SEROMA FORMATION, ADHESIONS, HEMATOMAS, INFLAMMATION, FISTULA FORMATION AND RECURRENCE.\u00bf THE INSTRUCTIONS FOR USE FURTHER STATES: \u00bfANY POSTOPERATIVE INFECTION SHOULD BE AGGRESSIVELY TREATED AT THE EARLIEST POSSIBLE TIME. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\u00bf PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE PERSISTENT/SYMPTOMATIC SEROMA AND WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT\u00bfS UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THERE IS INSUFFICIENT INFORMATION AVAILABLE FOR GORE TO REASONABLY DRAW CONCLUSIONS RELATED TO ASPECTS OF THE EVENT, THEREFORE CONCLUSION CODE \u00bfD15: CAUSE NOT ESTABLISHED\u00bf IS BEING USED. INSUFFICIENT INFORMATION MAY INCLUDE LIMITED OR MISSING RELEVANT MEDICAL RECORDS, INVOLVEMENT OF MULTIPLE IMPLANTED DEVICES (INCLUDING NON-GORE DEVICES) IN THE FIELD OF TREATMENT, PATIENT NON-COMPLIANCE, AND/OR A GENERAL LACK OF AVAILABLE DETAIL OR SPECIFICITY RELATED TO AN ADVERSE EVENT AND/OR DEVICE. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. BASED ON MANUFACTURE DATE OF DEVICE, PRODUCT TRACKING UNAVAILABLE. \u00bf W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "321813450", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B7: ADDED MEDICAL HISTORY. CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 1999, (B)(6), MD. INDICATIONS: \u00bf(B)(6) HAD HAD SEVERAL VENTRAL INCISIONAL HERNIA REPAIRS IN THE PAST. SHE HAS MORBID OBESITY. AND SHE STATES, FOR THE PAST (B)(6) MONTHS, SHE HAS BEEN HAVING PAIN JUST ABOVE THE UMBILICUS. AND SHE HAS SOME NAUSEA, AND NO VOMITING, AND NO SYMPTOMS SUGGESTIVE OF STRANGULATION. SHE HAD A CT SCAN OF WHICH, SHOWED A VENTRAL INCISIONAL HERNIA ABOVE THE UMBILICUS WITH THE LOOP OF SMALL BOWEL CAUGHT IN THE SAC. REPAIR WAS DISCUSSED WITH THE PATIENT. SHE UNDERSTOOD AND AGREED. I ALSO EXPLAINED TO HER THAT SHE IS PROBABLY GOING TO NEED SURGERY FOR GASTRIC STAPLING IN THE FUTURE TO DECREASE HER MORBID OBESITY\u00bf. IMPLANT #1 PROCEDURE: REPAIR RECURRENT VENTRAL INCISIONAL HERNIA USING GORE-TEX MESH AND LYSIS OF ADHESIONS. IMPLANT: GORE-TEX\u00ae SOFT TISSUE PATCH [(B)(4)]. IMPLANT #1 DATE: (B)(6)1999, (HOSPITALIZATION DATES UNKNOWN). (B)(6) 1999, (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL INCISIONAL HERNIA. PROCEDURE: \u00bfUNDER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA WITH THE PATIENT IN THE SUPINE POSITION, THE SKIN OVER THE ENTIRE ABDOMEN WAS PREPPED WITH BETADINE SCRUB SOLUTION AND STERILE DRAPES WERE THEN APPLIED. AN ELLIPTICAL INCISION OF THE OLD SCAR OVER THE DISTAL THIRD OF THE PREVIOUS SCAR WAS THEN CARRIED OUT THROUGH SKIN AND SUBCUTANEOUSLY AND BLEEDERS WERE CLAMPED AND CAUTERIZED. IT WAS EVIDENT, THAT THE PATIENT HAD A HERNIAL SAC, OF WHICH WAS COMING OUT OF THE LOWER PART OF THE END OF AN OLD PROLENE MESH, WHICH HAD COME OFF FROM THE FASCIAL SIDE. THIS HERNIAL SAC WAS THEN DISSECTED OFF DOWN TO THE OPENING OF THE FASCIA. AND THE MESH AND THE SAC WAS OPENED, AND IT CONTAINED A LOOP OF SMALL BOWEL, WHICH WAS THEN FREED UP FROM THE SAC WITHOUT DIFFICULTY. SOME OF THE MESH WAS REMOVED. THE ONE ATTACHED TO THE FASCIA, AND THERE WAS A DEFECT OF APPROXIMATELY 8 BY 6 CM IN DIAMETER. THERE WAS NO OTHER LOOPS OF BOWEL CAUGHT IN THE AREA. THE OMENTUM WAS THEN FREED UP FROM THE ANTERIOR ABDOMINAL WALL, SO THAT WE COULD COVER THE BOWELS WELL TO PREVENT CONTACT BETWEEN THE BOWEL AND MESH ITSELF. A GORE-TEX MESH WAS THEN FASHIONED, AND MEASURING ABOUT AT LEAST 10 BY 8 CM AND WAS THEN SUTURED TO THE EDGES OF THE FASCIAL DEFECT. AND THE DEFECT ON THE OLD PROLENE MESH, CHOOSING A GOOD REINFORCEMENT OF THE POSTERIOR ABDOMINAL WALL. THE FASCIA WAS CLOSED PARTIALLY ON TOP OF THE GORE-TEX MESH USING A RUNNING SUTURE OF ABOUT #0 NOVOFIL. HEMOSTASIS WAS ACHIEVED AND EXCELLENT. THE SUBCUTANEOUS TISSUES WAS [SIC] THEN CLOSED WITH INTERRUPTED SUTURES OF #3-0 DEXON AND DECIDED NOT TO USE ANY DRAINS. THE SKIN WAS THEN CLOSED WITH SURGICAL STAPLES. A COMPRESSIVE DRY STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL. AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION\u00bf. (B)(6) 1999, (B)(6). IMPLANT STICKER. \u00bfGORE-TEX SOFT TISSUE PATCH\u00bf. ITEM#: (B)(4), LOT#: (B)(6). (B)(6)1999, (B)(6), MD. PATHOLOGY REPORT, DIAGNOSIS: SOFT TISSUE, ABDOMINAL WALL, HERNIORRHAPHY DENSE FIBROVASCULAR CONNECTIVE TISSUE AND FIBROADIPOSE TISSUE, WITH SUTURE GRANULOMA (CLINICALLY, RECURRENT VENTRAL HERNIA); TISSUE SOURCE: ABDOMINAL WALL; GROSS DESCRIPTION: \u00bfRECEIVED IN FORMALIN LABELLED \u00bfABDOMINAL WALL\u00bf IS A MOTTLED WHITE PINK TO TAN YELLOW. FOCALLY CAUTERIZED RUBBERY TISSUE RANGING FROM 1.8 X 1.6 X 0.6 CM TO 6.5 X 2.0 X 1.2 CM. SEVERAL OF THE TISSUES DISPLAY BLUE SYNTHETIC SUTURE MATERIAL. REPRESENTATIVE SECTIONS ARE SUBMITTED LABELLED 1 AND 2\u00bf. RELEVANT MEDICAL INFORMATION: (B)(6) 2000, (B)(6), MD. ASSISTANT: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: MORBID OBESITY VERTICAL BANDED GASTROPLASTY. IMPLANT: TRELEX NATURAL MESH; INDICATIONS: \u00bfTHE PATIENT IS A 41 YEAR OLD FEMALE WITH A HISTORY OF MORBID OBESITY WHOSE PAST SURGICAL HISTORY INCLUDED EXPLORATORY LAPAROTOMY AND OPEN CHOLECYSTECTOMY. THE PATIENT'S HISTORY ALSO INCLUDED RECURRENT VENTRAL HERNIAS, WHICH HAVE BEEN REPAIRED MULTIPLE TIMES WITH MESH. AS THE PATIENT'S STATUS IS CURRENTLY, SHE HAS A LARGE VENTRAL DEFECT, WHICH SHOWS NO SIGNS OF INCARCERATION. IN ADDITION, THE PATIENT HAS A SINGLE DRAINING SINUS PRESUMABLY FROM COLONIZED MESH, WHICH STILL REMAINS IN PLACE. AND THE PATIENT DRAINS CONSTANT AMOUNTS OF SEROPURULENT MATERIAL FROM A SMALL OPENING IN HER ANTERIOR ABDOMINAL WALL. SHE IS FOLLOWED BY DR. (B)(6) FOR THESE MULTIPLE HERNIAS. AT THIS POINT, THE PATIENT'S WEIGHT/HEIGHT RATIO BMI IS 40. AND DESPITE MULTIPLE ATTEMPTS AT LIFESTYLE CHANGES AND DIETING, THE PATIENT HAS HAD NO LUCK AT WEIGHT LOSS. THE PATIENT UNDERSTANDS THE RISKS OF THE PROCEDURE. AND THE FACT THAT THE ENTIRE PROCEDURE MAY NOT BE COMPLETED SECONDARY TO THE SIZE OF HER VENTRAL HERNIA AND POSSIBLE INVOLVEMENT OF SMALL BOWEL. NO ATTEMPT WILL BE MADE AT VENTRAL HERNIA REPAIR OR RESECTION OF ANY MESH\u00bf. FINDINGS: \u00bfTHIS 41 YEAR OLD MORBIDLY OBESE FEMALE WITH A HISTORY OF SEVERAL VENTRAL HERNIA REPAIRS AFTER OPEN CHOLECYSTECTOMY UNDERWENT A VERTICAL BANDED GASTROPLASTY. THE BYPASS PORTION OF THE PROCEDURE COULD NOT BE COMPLETED SECONDARY TO THE ADHERENCE OF HER SMALL BOWEL WITHIN HER ABDOMEN WITH ADHESIONS AND POSSIBLE INVOLVEMENT IN A MASSIVE VENTRAL HERNIA. AS DISCUSSED WITH THE PATIENT PREOPERATIVELY, THE RISK OF REPAIR OF THIS HERNIA WITH INFECTED MESH WAS TOO GREAT TO JUSTIFY CONTINUING THE BYPASS PROCEDURE IN THIS CASE\u00bf. PROCEDURE: \u00bfWITH THE PATIENT LYING SUPINE AND ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA ADMINISTERED, THE PATIENT'S ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE MASSIVE DEFECT IN THE PATIENT'S VENTRAL HERNIA WAS APPRECIATED PREOPERATIVELY AND A LEFT SUBCOSTAL INCISION WAS MADE MEASURING APPROXIMATELY 15 CM LONG IN THE PATIENT'S LEFT UPPER QUADRANT. THIS WAS CARRIED DOWN TO THE SOFT TISSUE AND THE ANTERIOR AND POSTERIOR SHEATHS OF THE RECTUS MUSCLE AND THE PERITONEAL CAVITY WAS ENTERED WITHOUT INJURY TO UNDERLYING STRUCTURES. IT BECAME QUITE OBVIOUS WITH THE LYSIS OF SEVERAL ADHESIONS THAT THE STOMACH WAS INDEED REACHABLE AND THE GASTRIC PORTION OF THE PROCEDURE COULD BE UNDERTAKEN. HOWEVER, IT WAS NOTED, DUE TO MASSIVE ADHESIONS AND BOWEL WITHIN THIS LARGE VENTRAL DEFECT THAT ONLY APPROXIMATELY 70 CM OF SMALL BOWEL COULD BE REACHED AND WORKED ON. AS DISCUSSED WITH THE PATIENT PREOPERATIVELY, THE INTRAOPERATIVE DECISION WAS MADE NOT TO TRY TO REDUCE OR REPAIR ANY OF THIS HERNIA GIVEN THE FACT THAT THERE WAS MESH WITH SOME PORTIONS OF INFECTED MESH PRESENT. FOR THIS REASON, THE INTRAOPERATIVE DECISION TO ONLY DO THE VERTICAL BANDED GASTROPLASTY WITHOUT THE BYPASS WAS MADE. THE STOMACH WAS MOBILIZED ALONG THE LESSER CURVATURE. AND ALSO THE GASTROESOPHAGEAL JUNCTION ISOLATED AND SURROUNDED WITH THE PENROSE DRAIN. ALONG THE LESSER CURVATURE OF THE STOMACH, APPROXIMATELY 10 CM FROM THE GASTROESOPHAGEAL JUNCTION, AN EEA STAPLER WAS PASSED THROUGH THE ANTERIOR WALL EXITING THE POSTERIOR WALL OF THE STOMACH. AND WAS FIRED CREATING AN APPROXIMATELY 2 CM DIAMETER HOLE DIRECTLY IN THE STOMACH. THE LESSER SAC WAS FREED OF ALL ADHESIONS AND SERIAL GIA STAPLERS WERE USED TO TRANSECT FROM THE POINT OF THIS CIRCULAR OPENING TO THE LATERAL EDGE OF THE GASTROESOPHAGEAL JUNCTION. AN ESOPHAGEAL STENT WAS IN PLACE TO ASSURE AN ADEQUATE POUCH WAS CREATED. THE STAPLE LINES OF THE GIA WERE THEN OVERSEWN WITH INTERRUPTED AND RUNNING SILK SUTURES. A PROLENE MESH BAND WAS THEN CREATED AT THE DISTAL END OF THE POUCH AND SUTURED LOOSELY AROUND THE DISTAL END. THE ABDOMEN WAS THOROUGHLY IRRIGATED. GOOD HEMOSTASIS WAS NOTED. THE ABDOMEN WAS THEN CLOSED IN MULTIPLE LAYERS WITH A LAYER OF RUNNING VICRYL SUTURE IN THE POSTERIOR SHEATH, ANTERIOR SHEATH, SCARPA'S AND INTERRUPTED VICRYL SUTURES IN THE DERMAL LAYER. THE SKIN WAS THEN CLOSED WITH STAPLES AND A DRY, STERILE DRESSING APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL. AND WAS THE EXTUBATED AND STABLE TO THE POST ANESTHESIA CARE UNIT\u00bf. EXPLANT #1 PREOPERATIVE COMPLAINTS: (B)(6) 2000, (B)(6), MD. INDICATIONS: \u00bfTHIS PATIENT HAS HAD MULTIPLE VENTRAL HERNIAS IN THE PAST AND SHE IS MASSIVELY OBESE. SHE RECENTLY UNDERWENT A GASTROPLASTY, BECAUSE OF HER INABILITY TO LOSE WEIGHT. AND THE FACT THAT SHE HAS A RECURRENT HERNIA, DUE TO INCREASED OBESITY. POSTOPERATIVELY AFTER THE GASTROPLASTY, SHE DEVELOPED A WOUND INFECTION, WHICH WAS OPENED AND DRAINED BY DR. (B)(6). AND SHE ALSO DEVELOPED A FISTULA OF THE MID PORTION OF THE WOUND OF THE PREVIOUS HERNIA, WHICH HAD BEEN PRESENT OFF AND ON BEFORE. THE IMPRESSION WAS THAT SHE HAD A SMALL BOWEL FISTULA AND SHE IS NOW ADMITTED BECAUSE OF INCREASED PAIN AND INCREASED DRAINAGE FROM THE MID PORTION OF THE WOUND ON THE MID LINE\u00bf. EXPLANT #1 PROCEDURE: REPAIR OF MASSIVE VENTRAL INCISIONAL HERNIA WITH REPAIR OF SMALL BOWEL FISTULA BY DOING ENTEROENTEROSTOMY AND APPLICATION OF DEXON MESH OVER THE REPAIRED HERNIA. EXPLANT GORE-TEX. EXPLANT #1 DATE: (B)(6) 2000, (HOSPITALIZATION DATES UNKNOWN). (B)(6) 2000, (B)(6), MD. OPERATIVE REPORT, PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: LARGE VENTRAL INCISIONAL HERNIA AND SMALL BOWEL FISTULA; ANESTHESIA: GENERAL; PROCEDURE: \u00bfUNDER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA AND WITH THE PATIENT IN THE SUPINE POSITION, THE SKIN OF THE ENTIRE ABDOMEN WAS PREPPED WITH BETADINE SCRUB AND SOLUTION. STERILE DRAPES WERE THEN APPLIED AND AN INCISION WAS THEN MADE AROUND THE OLD SURGICAL SCAR. AND ON THAT INCLUDED THE PART WHERE THERE WAS A FISTULA ON THE MID PORTION OF THE MID LINE UPPER ABDOMEN AND AROUND THE UMBILICUS. THE INCISION WAS THEN DEEPENED THROUGH SKIN AND SUBCUTANEOUS TISSUE. IT WAS EVIDENT, THAT THE PATIENT HAD A BIG COLLECTION OF FLUID ON THE LEFT SIDE OF THE OLD SCAR, WHICH WAS CONSISTENT WITH SMALL BOWEL CONTENTS AND A SPECIMEN OF THAT WAS TAKEN FOR CULTURE AND SENSITIVITY. WE THEN PROCEEDED BY RESECTING THE ENTIRE SCAR AND SENDING IT OUT TO PATHOLOGY. THE PATIENT HAD A VERY LARGE VENTRAL INCISIONAL HERNIA WHICH CONTAINED THE OLD PROLENE MESH, AS WELL AS A GORE-TEX MESH AND ALL THE OLD MESH OF PROLENE, AS WELL AS THE GORE-TEX MESH WAS REMOVED AND SENT TO PATHOLOGY. ASSOCIATED WITH THIS SCAR WERE THE BORDERS OF THE FASCIA, WHICH ALSO CONTAINED SMALL SEGMENT OF THE SMALL BOWEL, WHICH WAS DEEPLY ADHERENT TO THE SCAR WITH THE SMALL BOWEL FISTULA. I HAD TO RESECT A PART OF THE SMALL BOWEL, WHICH WAS THE CAUSE OF HER SMALL BOWEL FISTULA. WITH THIS DONE, THEN THE BORDERS OF THE FASCIA WERE REFRESHED AND UNTIL COMPLETELY NORMAL TISSUE. AND ALL THE SCAR TISSUE, AS WELL AS THE MESH HAD BEEN REMOVED AND SENT TO PATHOLOGY. WITH THIS DONE, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED WITH SALINE AND DRIED AND EXAMINATION OF THE ENTIRE CAVITY REVEALED TO BE NORMAL. I COULD NOT FIND ANY DEFINITE STONES IN THE GALLBLADDER. THERE WERE ADHESIONS IN THE LEFT UPPER QUADRANT FROM THE PREVIOUS GASTROPLASTY. AND I DID NOT ENTER IN THAT AREA. THERE WAS NO EVIDENCE OF INTRAABDOMINAL ABSCESS AND THE ENTIRE SMALL BOWEL WAS RUN FROM THE LIGAMENT OF TREITZ ALL THE WAY DOWN TO THE ILEOCECAL VALVE, REVEALING ONLY THIS DEFECT OF THE SMALL BOWEL, WHICH WAS THE AREA, WHICH WAS CAUSING THE SMALL BOWEL FISTULA. AT THIS STAGE, I DECIDED TO REPAIR THIS SMALL BOWEL FISTULA BY BRINGING THE TWO LOOPS OF THE PROXIMAL DISTAL END OF THE BOWEL AROUND THE AREA OF THE DEFECT ON THE ANTERIOR WALL OF THE BOWEL. AND I DID INSERT A GIA THROUGH THESE TWO OPENINGS IN THE PROXIMAL AND DISTAL ENDS OF THE BOWEL AND SIDE-TO-SIDE (PROXIMAL END) FUNCTIONAL END-TO-END ANASTOMOSIS WAS THEN CARRIED OUT. THE GIA STAPLER WAS APPLIED AND FIRED. AND THE OPENING OF THE BOWEL WAS THEN CLOSED USING TA-55, ACHIEVING EXCELLENT LUMEN OF THE BOWEL AND WITH A GOOD BLOOD SUPPLY AND NO EVIDENCE OF ANY TENSION. WITH THIS DONE, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED WITH SALINE AND DRIED AND TO HAVE A COMPLETELY CLEAN RETURN. THE FASCIAL DEFECT MEASURED ABOUT 15 X 10 CM. AT THIS STAGE, I FELT THAT SINCE THERE WAS A SMALL BOWEL FISTULA, THAT I WOULD NOT USE NONABSORBABLE MESH TO CLOSE THE FASCIAL DEFECT, BECAUSE I WAS AFRAID THAT THIS WOULD BE CONTAMINATED WITH THE SMALL BOWEL CONTENTS. AND IT COULD CAUSE PERSISTENT INFECTION ON THE WOUND. AND ALSO COULD IN THE FUTURE CAUSE RECURRENT HERNIA, DUE TO INFECTION. SO I FELT THAT AT BEST, EVEN THOUGH THERE WOULD BE SOME SMALL AMOUNT OF TENSION ON THE WOUND, WAS TO CLOSE THE WOUND IN ONE LAYER USING A RUNNING SUTURE OF #2 ETHILON BRINGING THE ANTERIOR AND POSTERIOR FASCIA, AS WELL AS PERITONEUM. THIS WAS DONE IN SHORT RUNS OF CONTINUOUS SUTURE WITH #2 NYLON AND ACHIEVING. ALTHOUGH, THERE WAS A LITTLE BIT OF TENSION, A GOOD CLOSURE OF THE FASCIA DEFECT AND THE ENTIRE WOUND. I HAVE TO ADD THAT THERE WERE MULTIPLE OTHER DEFECTS ON THE MIDLINE ON THE UPPER PART OF THE INCISION. I WAS PRETTY SATISFIED WITH THE CLOSURE. AND ON TOP OF THAT THEN I DID PUT A PIECE OF DEXON MESH REINFORCING THIS, WHICH IS AN ABSORBABLE MESH. AND THIS WAS THEN SUTURED OVER THE FASCIA USING A RUNNING SUTURE OF #2-0 PROLENE ACHIEVING A GOOD REINFORCEMENT OF THE FASCIAL CLOSURE. THE SUBCUTANEOUS WAS THEN CLOSED WITH INTERRUPTED SUTURES OF #3-0 DEXON. THE SKIN WAS CLOSED WITH SURGICAL STAPLES. I DID PUT A JACKSON-PRATT DRAIN IN THE WOUND. AND BROUGHT IT OUT THROUGH A SEPARATE STAB WOUND IN THE LOWER PART OF THE ABDOMEN. THIS JACKSON-PRATT DRAIN WAS SUTURED IN PLACE WITH A #4-0 NYLON. A COMPRESSIVE DRY, STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL. I HAVE TO ADD THAT THERE WERE NO OTHER ABNORMALITIES IN THE SMALL BOWEL, BESIDES THE ONE IN THE AREA THAT WAS CAUSING THE FISTULA. AND THE ENTIRE LARGE BOWEL WAS INSPECTED FROM THE CECUM ALL THE WAY DOWN TO THE RECTOSIGMOID. AND THAT DID NOT SHOW EVIDENCE OF A MASS AND NO EVIDENCE OF DIVERTICULITIS, BUT A FEW DIVERTICULA AND PALPATION OF THE UTERUS AND THE OVARIES DID NOT REVEAL ANY EVIDENCE OF A MASS. THEY WERE OF NORMAL SIZE. THE PATIENT TOLERATED THE PROCEDURE WELL. AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION\u00bf. (B)(6) 2000, (B)(6), MD. PATHOLOGY REPORT, TISSUE SOURCE: HERNIA SAC SEGMENT OF SMALL BOWEL; DIAGNOSIS: LABELED \u00bfHERNIA SAC AND SEGMENT OF SMALL BOWEL\u00bf, HEMORRHAGIC MUCOSAL NECROSIS, SMALL INTESTINE WITH ADHESION TO FASCIA AND SKIN AT SITE OF HERNIA REPAIR; NOTE: SEGMENT OF SMALL BOWEL APPEARS TO BE ADHERENT TO FASCIA AS WELL AS FIBROADIPOSE TISSUE AND SKIN AT THE SITE OF MESH PLACEMENT AND DERMAL SCAR. APPEARANCES ARE CONSISTENT WITH AN ENTEROCUTANEOUS FISTULA, STATUS POST PREVIOUS REPAIR OF ABDOMINAL HERNIA. GROSS DESCRIPTION: LABELLED \"HERNIA SAC, SEGMENT OF SMALL BOWEL\", \u00bfRECEIVED IN FORMALIN IS AN 18.0 X 4.0 CM ELLIPSE OF TAN HAIRLESS SKIN WITH TWO STELLATE SHAPED RETRACTED SCARS MEASURING 2.0 CM EACH. THE SKIN ELLIPSE IS ATTACHED TO A 25.0 X 19.0 CM FIBROUS AND MEMBRANOUS TISSUE RANGING IN THICKNESS FROM 1.3 X 0.3 CM. MULTIPLE ATTACHED UNREMARKABLE FATTY LOBULES ARE ALSO IDENTIFIED. THE FIBROMEMBRANOUS TISSUE IS INTERMIXED WITH A MESH WITH MULTIPLE SURGICAL STITCHES EMBEDDED INTO DENSE FIBROUS TISSUE. SIX ADDITIONAL PIECES OF FIBROUS TISSUE WITH SURGICAL STITCHES INTERMIXED WITH PIECES OF MESH ARE ALSO RECEIVED, AVERAGING IN SIZE FROM 4.0 X 2.5 X 0.4 CM, TO 13.0 X 4.5 X 0.5 CM. A 1.1 CM LONG X 2.6 CM IN DIAMETER DONUT SHAPED SEGMENT OF BOWEL IS ALSO IDENTIFIED. THE MUCOSAL SURFACE IS TAN AND EDEMATOUS WITHOUT DISTINCT LESIONS. THE WALL MEASURES 0.3 CM AND REVEALS AN UNREMARKABLE MUSCULARIS PROPRIA WITH SURROUNDING HEMORRHAGIC SOFT TISSUES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: 1. SEGMENT OF BOWEL, TWO PIECES. 2. SKIN WITH SCAR, ONE SECTION. 3. FIBROMEMBRANOUS TISSUE, TWO PIECES. 4. FIBROMEMBRANOUS TISSUE, TWO PIECES\u00bf. IMPLANT #2, #3, #4 PREOPERATIVE COMPLAINTS: NO INFORMATION; IMPLANT #2, #3, #4 PROCEDURE: LAPAROSCOPIC LYSIS OF ADHESIONS AND INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH; IMPLANT: GORE\u00ae DUALMESH\u00ae BIOMATERIAL X 3 [ (B)(4), 20X30CM; (B)(4), 20X30CM; (B)(4), 10X15CM]; IMPLANT #2, #3, #4 DATE: (B)(6) 2001, (HOSPITALIZATION DATES UNKNOWN). (B)(6) 2001, [DICTATION DATE: (B)(6) 2001]: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA; POSTOPERATIVE DIAGNOSIS: MULTIPLE RECURRENT INCISIONAL HERNIAS; ANESTHESIA: GENERAL; PROCEDURE: \u00bfTHE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION. AND AFTER THE ADMINISTRATION OF GENERAL ENDOTRACHEAL ANESTHESIA, THE ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. A STERI-DRAPE WAS USED FOR THIS AND THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS. VENODYNE BOOTS WERE PLACED AND A FOLEY CATHETER AND AN OROGASTRIC TUBE WERE INSERTED. THE PERITONEAL CAVITY WAS ACCESSED USING AN OPEN TECHNIQUE. THE ABDOMEN WAS INSUFFLATED TO 12 MMHG WITH C02. ADDITIONAL WORKING PORTS WERE PLACED. AND THERE WAS NOTED, TO BE NUMEROUS DENSE ADHESIONS BETWEEN THE LIVER AND THE ABDOMINAL WALL, AS WELL AS BETWEEN THE BOWEL AND OMENTUM AND ABDOMINAL WALL. THIS WAS A PAINSTAKING LYSIS OF ADHESIONS. IT TOOK A CONSIDERABLE AMOUNT OF TIME AND WAS VERY DIFFICULT. DESPITE THIS, THIS WAS SAFELY PERFORMED WITH METICULOUS SURGICAL TECHNIQUE. WE USED MINIMAL CAUTERY FOR THIS PORTION OF THE OPERATION. ONCE WE EXPOSED THE ABDOMINAL WALL, THERE WAS A 2 X 2 CM PERIUMBILICAL DEFECT AND A 17 X 17 CM DEFECT JUST TO THE LEFT OF THE MIDLINE AT THE COSTAL MARGIN. IN ORDER TO COMPLETELY COVER THE DEFECT, AS WELL AS THE ENTIRE MIDLINE INCISION, WE PLACED A 20 X 30 MESH TRANSVERSELY UP UNDER THE LEFT COSTAL MARGIN. AND A 20 X 30 MESH PLACED LONGITUDINALLY TO COVER THE PERIUMBILICAL DEFECT IN THE ENTIRE OLD INCISION. THE LEFT LOWER PORTION OF THE 17 X 17 CM DEFECT WAS CLOSE, SO WE ADDED AN ADDITIONAL 10 X 15 CM PATCH TO SECURE THIS CORNER. THE COMBINATION OF MESHES WERE SECURED WITH 11 FULL THICKNESS CV2 GORE-TEX SUTURES AND TACKS AROUND THE PERIPHERY. THE MESH EXTENDED UP TO THE XIPHOID PROCESS AND CLEARLY ABOVE THE LEFT COSTAL MARGIN GIVING US ADEQUATE OVERLAP AROUND ALL ASPECTS OF THE DEFECTS AND COVERING COMPLETELY THE OLD INCISIONS. THE PORTS WERE ALL REMOVED AND THE C02 WAS ALLOWED TO ESCAPE. THE SKIN WAS CLOSED IN A STANDARD FASHION WITH SUBCUTICULAR MONOCRYL AND STERI-STRIPS. THE PATIENT TOLERATED THE PROCEDURE WELL. AND THERE WERE NO COMPLICATIONS. ESTIMATED BLOOD LOSS WAS MINIMAL. SHE WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION\u00bf. (B)(6) 2001, (B)(6). IMPLANT STICKERS. 1. \u00bfGORE-TEX DUALMESH BIOMATERIAL\u00bf ITEM#: (B)(4), LOT#: (B)(4); 2. \u00bfGORE-TEX DUALMESH BIOMATERIAL\u00bf ITEM#: (B)(4), LOT#: (B)(4); 3. \u00bfGORE-TEX DUALMESH BIOMATERIAL\u00bf ITEM#: (B)(4). LOT#: (B)(4). RELEVANT MEDICAL INFORMATION: (B)(6) 2002, (B)(6), MD. OPERATIVE REPORT, PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: PERIRECTAL AND ISCHIORECTAL ABSCESS. INFECTED SEBACEOUS CYST OF THE FACE. PROCEDURE: INCISION AND DRAINAGE OF ISCHIORECTAL ABSCESS. EXCISION OF INFECTED SEBACEOUS CYST OF THE FACE, 1-2 CM. RIGID SIGMOIDOSCOPY; FINDINGS: \u00bfTHE PATIENT HAD AN EXTENSIVE ABSCESS THAT EXTENDED ALONG THE LEFT SIDE OF THE RECTUM AND UNDER THE LEVATORS. IT WENT AROUND THE MIDLINE POSTERIORLY, AND ANTERIORLY IT WENT TO THE COOPER'S LIGAMENT AND PUBIS. LATERALLY IT EXTENDED INTO THE GLUTEUS. IT HAD VERY FOUL SMELLING ODOR. SURPRISINGLY, THE TISSUES OF THE CAVITY DID NOT SHOW ANY NECROSIS. RIGID SIGMOIDOSCOPY UP TO 20 CM DID NOT SHOW ANY OBVIOUS CANCER. I DID SEE SOME DIVERTICULA, BUT I DID NOT SEE ANY INFLAMMATION\u00bf. (B)(6) 2002, (B)(6), MD. OPERATIVE REPORT, PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: EXTENSIVE PERIRECTAL ABSCESS, PROCEDURE: DRESSING CHANGES UNDER ANESTHESIA; FINDINGS: \u00bfTHERE WAS STILL PURULENT FLUID DEEP IN THE CAVITY OF THE ABSCESS, ONE EXTENDING BELOW THE LEVATORS AND AROUND THE AREA OF THE COOPER'S LIGAMENT AND PUBIS. THE TISSUES WERE ACTUALLY FAIRLY VIABLE, EXCEPT FOR THE MOST SUPERFICIAL PART THAT SHOWED SOME SUPERFICIAL BLACK NECROSIS OF THE CONNECTIVE TISSUE. THERE WAS NO OBVIOUS FISTULA CONNECTING WITH THE RECTUM\u00bf. (B)(6) 2011, (B)(6), MD. OPERATIVE REPORT, ASSISTANT: (B)(6), MD. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: INFRARENAL ABDOMINAL AORTIC ANEURYSM; PROCEDURE: ENDOVASCULAR ANEURYSM REPAIR WITH GORE EXCLUDER C3 GRAFT. CUT-DOWNS WERE PERFORMED ON BOTH GROINS. (B)(6) 2011, (B)(6), MD. IMPLANT RECORD, EXCLUDER IMPLANT SITE: AORTA; EXCLUDER. IMPLANT SITE: RIGHT COMMON ILIAC ARTERY." }, { "mdr_text_key": "205271040", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT SHOULD BE NOTED THAT THE GORE-TEX\u00ae SOFT TISSUE PATCH INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\"" }, { "mdr_text_key": "205271041", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT MULTIPLE OPEN INCISIONAL HERNIA REPAIRS ON (B)(6) 1999 AND (B)(6) 2001 WHEREBY A GORE-TEX\u00ae SOFT TISSUE PATCH AND GORE\u00ae DUALMESH\u00ae BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2000 AND (B)(6) 2016, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF PREVIOUS GORE MESH, REMOVAL OF SMALL BOWEL FISTULA, RESECTION OF SMALL BOWEL DUE TO FISTULA, RECURRENT VENTRAL INCISIONAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH, ABDOMINAL WOUND DRAINAGE, SEVERE PAIN, DEBRIDEMENT OF NON-HEALING OPEN WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3750 W. KILTIE LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86004", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/11/2020;04/01/2021;03/13/2023" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FLAGSTAFF", "manufacturer_contact_address_1": "1505 N. FOURTH STREET", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "2017233-2020-01200", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "K992189", "date_of_event": "20000414", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "86004", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "WOMBLE", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "86005", "manufacturer_g1_state": "AZ", "reporter_country_code": "US", "manufacturer_contact_area_code": "928", "date_added": "20200901", "manufacturer_contact_f_name": "HEIDI", "device_date_of_manufacturer": "20010115", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "GORE\u00ae DUALMESH\u00ae BIOMATERIAL", "generic_name": "MESH, SURGICAL, POLYMERIC", "manufacturer_d_name": "W. L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "1505 N. FOURTH STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86004", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86004", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20060114", "model_number": "1DLMC07", "catalog_number": "1DLMC07", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FTL", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00733132601004", "udi_public": "00733132601004", "openfda": { "device_name": "Mesh, Surgical, Polymeric", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/14/2020;04/24/2021;04/24/2021", "manufacturer_contact_country": "US", "date_changed": "20240201", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "42 YR", "patient_sex": "Male", "patient_weight": "77 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230313", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "10480126", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200814", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "86005", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL WOODY MOUNTAIN B/P", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "323855827", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" \u00a0 THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "334287795", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSIONS. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. THROUGH GORE'S INVESTIGATION AND BASED ON THE AVAILABLE INFORMATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED. PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE\u00bfS INVESTIGATION. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\u00bf AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT\u00bfS UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. BASED ON MANUFACTURE DATE OF DEVICE, PRODUCT TRACKING UNAVAILABLE. REVIEW OF THE STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "321806142", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT #1 PREOPERATIVE COMPLAINTS: ON (B)(6) 1999: (B)(6), MD. INDICATIONS: \u00bfMRS. (B)(6) HAD SEVERAL VENTRAL INCISIONAL HERNIA REPAIRS IN THE PAST. SHE HAS MORBID OBESITY AND SHE STATES FOR THE PAST TWO MONTHS SHE HAS BEEN HAVING PAIN JUST ABOVE THE UMBILICUS AND SHE HAS SOME NAUSEA, AND NO VOMITING, AND NO SYMPTOMS SUGGESTIVE OF STRANGULATION. SHE HAD A CT SCAN OF WHICH SHOWED A VENTRAL INCISIONAL HERNIA ABOVE THE UMBILICUS WITH THE LOOP OF SMALL BOWEL CAUGHT IN THE SAC. REPAIR WAS DISCUSSED WITH THE PATIENT. SHE UNDERSTOOD AND AGREED. I ALSO EXPLAINED TO HER THAT SHE IS PROBABLY GOING TO NEED SURGERY FOR GASTRIC STAPLING IN THE FUTURE TO DECREASE HER MORBID OBESITY.\u00bf IMPLANT #1 PROCEDURE: REPAIR RECURRENT VENTRAL INCISIONAL HERNIA USING GORE-TEX MESH AND LYSIS OF ADHESIONS. IMPLANT: GORE-TEX\u00ae SOFT TISSUE PATCH [1410015010/P13344-039]. IMPLANT #1 DATE: ON (B)(6) 1999 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 1999: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL INCISIONAL HERNIA. PROCEDURE: \u00bfUNDER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA WITH THE PATIENT IN THE SUPINE POSITION, THE SKIN OVER THE ENTIRE ABDOMEN WAS PREPPED WITH BETADINE SCRUB SOLUTION AND STERILE DRAPES WERE THEN APPLIED. AN ELLIPTICAL INCISION OF THE OLD SCAR OVER THE DISTAL THIRD OF THE PREVIOUS SCAR WAS THEN CARRIED OUT THROUGH SKIN AND SUBCUTANEOUSLY AND BLEEDERS WERE CLAMPED AND CAUTERIZED. IT WAS EVIDENT THAT THE PATIENT HAD A HERNIAL SAC OF WHICH WAS COMING OUT OF THE LOWER PART OF THE END OF AN OLD PROLENE MESH WHICH HAD COME OFF FROM THE FASCIAL SIDE. THIS HERNIAL SAC WAS THEN DISSECTED OFF DOWN TO THE OPENING OF THE FASCIA AND THE MESH AND THE SAC WAS OPENED, AND IT CONTAINED A LOOP OF SMALL BOWEL WHICH WAS THEN FREED UP FROM THE SAC WITHOUT DIFFICULTY. SOME OF THE MESH WAS REMOVED; THE ONE ATTACHED TO THE FASCIA, AND THERE WAS A DEFECT OF APPROXIMATELY 8 BY 6 CM IN DIAMETER. THERE WAS NO OTHER LOOPS OF BOWEL CAUGHT IN THE AREA. THE OMENTUM WAS THEN FREED UP FROM THE ANTERIOR ABDOMINAL WALL SO THAT WE COULD COVER THE BOWELS WELL TO PREVENT CONTACT BETWEEN THE BOWEL AND MESH ITSELF. A GORE-TEX MESH WAS THEN FASHIONED AND MEASURING ABOUT AT LEAST 10 BY 8 CM AND WAS THEN SUTURED TO THE EDGES OF THE FASCIAL DEFECT AND THE DEFECT ON THE OLD PROLENE MESH, CHOOSING A GOOD REINFORCEMENT OF THE POSTERIOR ABDOMINAL WALL. THE FASCIA WAS CLOSED PARTIALLY ON TOP OF THE GORE-TEX MESH USING A RUNNING SUTURE OF ABOUT #0 NOVOFIL. HEMOSTASIS WAS ACHIEVED AND EXCELLENT. THE SUBCUTANEOUS TISSUES WAS [SIC] THEN CLOSED WITH INTERRUPTED SUTURES OF #3-0 DEXON AND DECIDED NOT TO USE ANY DRAINS. THE SKIN WAS THEN CLOSED WITH SURGICAL STAPLES. A COMPRESSIVE DRY STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.\u00bf ON (B)(6) 1999: (B)(6) CENTER. IMPLANT STICKER. \u00bfGORE-TEX SOFT TISSUE PATCH\u00bf. ITEM#: 1410015010. LOT#: P13344-039. ON (B)(6) 1999: (B)(6), MD. PATHOLOGY REPORT. DIAGNOSIS: SOFT TISSUE, ABDOMINAL WALL, HERNIORRHAPHY: DENSE FIBROVASCULAR CONNECTIVE TISSUE AND FIBROADIPOSE TISSUE, WITH SUTURE GRANULOMA (CLINICALLY, RECURRENT VENTRAL HERNIA). TISSUE SOURCE: ABDOMINAL WALL. GROSS DESCRIPTION: \u00bfRECEIVED IN FORMALIN LABELLED \u00bfABDOMINAL WALL\u00bf IS A MOTTLED WHITE PINK TO TAN YELLOW FOCALLY CAUTERIZED RUBBERY TISSUE RANGING FROM 1.8 X 1.6 X 0.6 CM TO 6.5 X 2.0 X 1.2 CM. SEVERAL OF THE TISSUES DISPLAY BLUE SYNTHETIC SUTURE MATERIAL. REPRESENTATIVE SECTIONS ARE SUBMITTED LABELLED 1 AND 2.\u00bf RELEVANT MEDICAL INFORMATION: ON (B)(6) 2000: (B)(6), MD. ASSISTANT: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: MORBID OBESITY. VERTICAL BANDED GASTROPLASTY. IMPLANT: TRELEX NATURAL MESH. INDICATIONS: \u00bfTHE PATIENT IS A 41 YEAR OLD FEMALE WITH A HISTORY OF MORBID OBESITY WHOSE PAST SURGICAL HISTORY INCLUDED EXPLORATORY LAPAROTOMY AND OPEN CHOLECYSTECTOMY. THE PATIENT'S HISTORY ALSO INCLUDED RECURRENT VENTRAL HERNIAS WHICH HAVE BEEN REPAIRED MULTIPLE TIMES WITH MESH. AS THE PATIENT'S STATUS IS CURRENTLY, SHE HAS A LARGE VENTRAL DEFECT WHICH SHOWS NO SIGNS OF INCARCERATION. IN ADDITION, THE PATIENT HAS A SINGLE DRAINING SINUS PRESUMABLY FROM COLONIZED MESH WHICH STILL REMAINS IN PLACE AND THE PATIENT DRAINS CONSTANT AMOUNTS OF SEROPURULENT MATERIAL FROM A SMALL OPENING IN HER ANTERIOR ABDOMINAL WALL. SHE IS FOLLOWED BY DR. RODAMILANS FOR THESE MULTIPLE HERNIAS. AT THIS POINT, THE PATIENT'S WEIGHT / HEIGHT RATIO BMI IS 40 AND DESPITE MULTIPLE ATTEMPTS AT LIFESTYLE CHANGES AND DIETING, THE PATIENT HAS HAD NO LUCK AT WEIGHT LOSS. THE PATIENT UNDERSTANDS THE RISKS OF THE PROCEDURE AND THE FACT THAT THE ENTIRE PROCEDURE MAY NOT BE COMPLETED SECONDARY TO THE SIZE OF HER VENTRAL HERNIA AND POSSIBLE INVOLVEMENT OF SMALL BOWEL. NO ATTEMPT WILL BE MADE AT VENTRAL HERNIA REPAIR OR RESECTION OF ANY MESH.\u00bf FINDINGS: \u00bfTHIS 41 YEAR OLD MORBIDLY OBESE FEMALE WITH A HISTORY OF SEVERAL VENTRAL HERNIA REPAIRS AFTER OPEN CHOLECYSTECTOMY UNDERWENT A VERTICAL BANDED GASTROPLASTY. THE BYPASS PORTION OF THE PROCEDURE COULD NOT BE COMPLETED SECONDARY TO THE ADHERENCE OF HER SMALL BOWEL WITHIN HER ABDOMEN WITH ADHESIONS AND POSSIBLE INVOLVEMENT IN A MASSIVE VENTRAL HERNIA. AS DISCUSSED WITH THE PATIENT PREOPERATIVELY, THE RISK OF REPAIR OF THIS HERNIA WITH INFECTED MESH WAS TOO GREAT TO JUSTIFY CONTINUING THE BYPASS PROCEDURE IN THIS CASE.\u00bf PROCEDURE: \u00bfWITH THE PATIENT LYING SUPINE AND ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA ADMINISTERED, THE PATIENT'S ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE MASSIVE DEFECT IN THE PATIENT'S VENTRAL HERNIA WAS APPRECIATED PREOPERATIVELY AND A LEFT SUBCOSTAL INCISION WAS MADE MEASURING APPROXIMATELY 15 CM LONG IN THE PATIENT'S LEFT UPPER QUADRANT. THIS WAS CARRIED DOWN TO THE SOFT TISSUE AND THE ANTERIOR AND POSTERIOR SHEATHS OF THE RECTUS MUSCLE AND THE PERITONEAL CAVITY WAS ENTERED WITHOUT INJURY TO UNDERLYING STRUCTURES. IT BECAME QUITE OBVIOUS WITH THE LYSIS OF SEVERAL ADHESIONS THAT THE STOMACH WAS INDEED REACHABLE AND THE GASTRIC PORTION OF THE PROCEDURE COULD BE UNDERTAKEN. HOWEVER, IT WAS NOTED DUE TO MASSIVE ADHESIONS AND BOWEL WITHIN THIS LARGE VENTRAL DEFECT THAT ONLY APPROXIMATELY 70 CM OF SMALL BOWEL COULD BE REACHED AND WORKED ON. AS DISCUSSED WITH THE PATIENT PREOPERATIVELY, THE INTRAOPERATIVE DECISION WAS MADE NOT TO TRY TO REDUCE OR REPAIR ANY OF THIS HERNIA GIVEN THE FACT THAT THERE WAS MESH WITH SOME PORTIONS OF INFECTED MESH PRESENT. FOR THIS REASON, THE INTRAOPERATIVE DECISION TO ONLY DO THE VERTICAL BANDED GASTROPLASTY WITHOUT THE BYPASS WAS MADE. THE STOMACH WAS MOBILIZED ALONG THE LESSER CURVATURE AND ALSO THE GASTROESOPHAGEAL JUNCTION ISOLATED AND SURROUNDED WITH THE PENROSE DRAIN. ALONG THE LESSER CURVATURE OF THE STOMACH, APPROXIMATELY 10 CM FROM THE GASTROESOPHAGEAL JUNCTION, AN EEA STAPLER WAS PASSED THROUGH THE ANTERIOR WALL EXITING THE POSTERIOR WALL OF THE STOMACH AND WAS FIRED CREATING AN APPROXIMATELY 2 CM DIAMETER HOLE DIRECTLY IN THE STOMACH. THE LESSER SAC WAS FREED OF ALL ADHESIONS AND SERIAL GIA STAPLERS WERE USED TO TRANSECT FROM THE POINT OF THIS CIRCULAR OPENING TO THE LATERAL EDGE OF THE GASTROESOPHAGEAL JUNCTION. AN ESOPHAGEAL STENT WAS IN PLACE TO ASSURE AN ADEQUATE POUCH WAS CREATED. THE STAPLE LINES OF THE GIA WERE THEN OVERSEWN WITH INTERRUPTED AND RUNNING SILK SUTURES. A PROLENE MESH BAND WAS THEN CREATED AT THE DISTAL END OF THE POUCH AND SUTURED LOOSELY AROUND THE DISTAL END. THE ABDOMEN WAS THOROUGHLY IRRIGATED. GOOD HEMOSTASIS WAS NOTED. THE ABDOMEN WAS THEN CLOSED IN MULTIPLE LAYERS WITH A LAYER OF RUNNING VICRYL SUTURE IN THE POSTERIOR SHEATH, ANTERIOR SHEATH, SCARPA'S AND INTERRUPTED VICRYL SUTURES IN THE DERMAL LAYER. THE SKIN WAS THEN CLOSED WITH STAPLES AND A DRY, STERILE DRESSING APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS THE EXTUBATED AND STABLE TO THE POST ANESTHESIA CARE UNIT.\u00bf EXPLANT #1 PREOPERATIVE COMPLAINTS: ON (B)(6) 2000: (B)(6), MD. INDICATIONS: \u00bfTHIS PATIENT HAS HAD MULTIPLE VENTRAL HERNIAS IN THE PAST AND SHE IS MASSIVELY OBESE. SHE RECENTLY UNDERWENT A GASTROPLASTY BECAUSE OF HER INABILITY TO LOSE WEIGHT AND THE FACT THAT SHE HAS A RECURRENT HERNIA DUE TO INCREASED OBESITY. POSTOPERATIVELY AFTER THE GASTROPLASTY, SHE DEVELOPED A WOUND INFECTION WHICH WAS OPENED AND DRAINED BY DR. (B)(6) AND SHE ALSO DEVELOPED A FISTULA OF THE MID PORTION OF THE WOUND OF THE PREVIOUS HERNIA WHICH HAD BEEN PRESENT OFF AND ON BEFORE. THE IMPRESSION WAS THAT SHE HAD A SMALL BOWEL FISTULA AND SHE IS NOW ADMITTED BECAUSE OF INCREASED PAIN AND INCREASED DRAINAGE FROM THE MID PORTION OF THE WOUND ON THE MID LINE.\u00bf EXPLANT #1 PROCEDURE: REPAIR OF MASSIVE VENTRAL INCISIONAL HERNIA WITH REPAIR OF SMALL BOWEL FISTULA BY DOING ENTEROENTEROSTOMY AND APPLICATION OF DEXON MESH OVER THE REPAIRED HERNIA. EXPLANT GORE-TEX. EXPLANT #1 DATE: ON (B)(6) 2000 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 2000: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: LARGE VENTRAL INCISIONAL HERNIA AND SMALL BOWEL FISTULA. ANESTHESIA: GENERAL. PROCEDURE: \u00bfUNDER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA AND WITH THE PATIENT IN THE SUPINE POSITION, THE SKIN OF THE ENTIRE ABDOMEN WAS PREPPED WITH BETADINE SCRUB AND SOLUTION. STERILE DRAPES WERE THEN APPLIED AND AN INCISION WAS THEN MADE AROUND THE OLD SURGICAL SCAR AND ON THAT INCLUDED THE PART WHERE THERE WAS A FISTULA ON THE MID PORTION OF THE MID LINE UPPER ABDOMEN AND AROUND THE UMBILICUS. THE INCISION WAS THEN DEEPENED THROUGH SKIN AND SUBCUTANEOUS TISSUE. IT WAS EVIDENT THAT THE PATIENT HAD A BIG COLLECTION OF FLUID ON THE LEFT SIDE OF THE OLD SCAR WHICH WAS CONSISTENT WITH SMALL BOWEL CONTENTS AND A SPECIMEN OF THAT WAS TAKEN FOR CULTURE AND SENSITIVITY. WE THEN PROCEEDED BY RESECTING THE ENTIRE SCAR AND SENDING IT OUT TO PATHOLOGY. THE PATIENT HAD A VERY LARGE VENTRAL INCISIONAL HERNIA WHICH CONTAINED THE OLD PROLENE MESH, AS WELL AS A GORE-TEX MESH AND ALL THE OLD MESH OF PROLENE, AS WELL AS THE GORE-TEX MESH WAS REMOVED AND SENT TO PATHOLOGY. ASSOCIATED WITH THIS SCAR WERE THE BORDERS OF THE FASCIA WHICH ALSO CONTAINED SMALL SEGMENT OF THE SMALL BOWEL WHICH WAS DEEPLY ADHERENT TO THE SCAR WITH THE SMALL BOWEL FISTULA. I HAD TO RESECT A PART OF THE SMALL BOWEL WHICH WAS THE CAUSE OF HER SMALL BOWEL FISTULA. WITH THIS DONE, THEN THE BORDERS OF THE FASCIA WERE REFRESHED AND UNTIL COMPLETELY NORMAL TISSUE AND ALL THE SCAR TISSUE, AS WELL AS THE MESH HAD BEEN REMOVED AND SENT TO PATHOLOGY. WITH THIS DONE, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED WITH SALINE AND DRIED AND EXAMINATION OF THE ENTIRE CAVITY REVEALED TO BE NORMAL. I COULD NOT FIND ANY DEFINITE STONES IN THE GALLBLADDER. THERE WERE ADHESIONS IN THE LEFT UPPER QUADRANT FROM THE PREVIOUS GASTROPLASTY AND I DID NOT ENTER IN THAT AREA. THERE WAS NO EVIDENCE OF INTRAABDOMINAL ABSCESS AND THE ENTIRE SMALL BOWEL WAS RUN FROM THE LIGAMENT OF TREITZ ALL THE WAY DOWN TO THE ILEOCECAL VALVE REVEALING ONLY THIS DEFECT OF THE SMALL BOWEL WHICH WAS THE AREA WHICH WAS CAUSING THE SMALL BOWEL FISTULA. AT THIS STAGE, I DECIDED TO REPAIR THIS SMALL BOWEL FISTULA BY BRINGING THE TWO LOOPS OF THE PROXIMAL DISTAL END OF THE BOWEL AROUND THE AREA OF THE DEFECT ON THE ANTERIOR WALL OF THE BOWEL AND I DID INSERT A GIA THROUGH THESE TWO OPENINGS IN THE PROXIMAL AND DISTAL ENDS OF THE BOWEL AND SIDE-TO-SIDE (PROXIMAL END) FUNCTIONAL END-TO-END ANASTOMOSIS WAS THEN CARRIED OUT. THE GIA STAPLER WAS APPLIED AND FIRED AND THE OPENING OF THE BOWEL WAS THEN CLOSED USING TA-55 ACHIEVING EXCELLENT LUMEN OF THE BOWEL AND WITH A GOOD BLOOD SUPPLY AND NO EVIDENCE OF ANY TENSION. WITH THIS DONE, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED WITH SALINE AND DRIED AND TO HAVE A COMPLETELY CLEAN RETURN. THE FASCIAL DEFECT MEASURED ABOUT 15 X 10 CM. AT THIS STAGE I FELT THAT SINCE THERE WAS A SMALL BOWEL FISTULA THAT I WOULD NOT USE NONABSORBABLE MESH TO CLOSE THE FASCIAL DEFECT BECAUSE I WAS AFRAID THAT THIS WOULD BE CONTAMINATED WITH THE SMALL BOWEL CONTENTS AND IT COULD CAUSE PERSISTENT INFECTION ON THE WOUND AND ALSO COULD IN THE FUTURE CAUSE RECURRENT HERNIA DUE TO INFECTION. SO I FELT THAT AT BEST, EVEN THOUGH THERE WOULD BE SOME SMALL AMOUNT OF TENSION ON THE WOUND, WAS TO CLOSE THE WOUND IN ONE LAYER USING A RUNNING SUTURE OF #2 ETHILON BRINGING THE ANTERIOR AND POSTERIOR FASCIA, AS WELL AS PERITONEUM. THIS WAS DONE IN SHORT RUNS OF CONTINUOUS SUTURE WITH #2 NYLON AND ACHIEVING, ALTHOUGH THERE WAS A LITTLE BIT OF TENSION, A GOOD CLOSURE OF THE FASCIA DEFECT AND THE ENTIRE WOUND. I HAVE TO ADD THAT THERE WERE MULTIPLE OTHER DEFECTS ON THE MIDLINE ON THE UPPER PART OF THE INCISION. I WAS PRETTY SATISFIED WITH THE CLOSURE AND ON TOP OF THAT THEN I DID PUT A PIECE OF DEXON MESH REINFORCING THIS WHICH IS AN ABSORBABLE MESH AND THIS WAS THEN SUTURED OVER THE FASCIA USING A RUNNING SUTURE OF #2-0 PROLENE ACHIEVING A GOOD REINFORCEMENT OF THE FASCIAL CLOSURE. THE SUBCUTANEOUS WAS THEN CLOSED WITH INTERRUPTED SUTURES OF #3-0 DEXON. THE SKIN WAS CLOSED WITH SURGICAL STAPLES. I DID PUT A JACKSON-PRATT DRAIN IN THE WOUND AND BROUGHT IT OUT THROUGH A SEPARATE STAB WOUND IN THE LOWER PART OF THE ABDOMEN. THIS JACKSON-PRATT DRAIN WAS SUTURED IN PLACE WITH A #4-0 NYLON. A COMPRESSIVE DRY, STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL. I HAVE TO ADD THAT THERE WERE NO OTHER ABNORMALITIES IN THE SMALL BOWEL BESIDES THE ONE IN THE AREA THAT WAS CAUSING THE FISTULA AND THE ENTIRE LARGE BOWEL WAS INSPECTED FROM THE CECUM ALL THE WAY DOWN TO THE RECTOSIGMOID AND THAT DID NOT SHOW EVIDENCE OF A MASS AND NO EVIDENCE OF DIVERTICULITIS, BUT A FEW DIVERTICULA AND PALPATION OF THE UTERUS AND THE OVARIES DID NOT REVEAL ANY EVIDENCE OF A MASS. THEY WERE OF NORMAL SIZE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.\u00bf ON (B)(6) 2000: (B)(6), MD. PATHOLOGY REPORT. TISSUE SOURCE: HERNIA SAC SEGMENT OF SMALL BOWEL. DIAGNOSIS: LABELED \u00bfHERNIA SAC AND SEGMENT OF SMALL BOWEL\u00bf. HEMORRHAGIC MUCOSAL NECROSIS, SMALL INTESTINE WITH ADHESION TO FASCIA AND SKIN AT SITE OF HERNIA REPAIR. NOTE: SEGMENT OF SMALL BOWEL APPEARS TO BE ADHERENT TO FASCIA AS WELL AS FIBROADIPOSE TISSUE AND SKIN AT THE SITE OF MESH PLACEMENT AND DERMAL SCAR. APPEARANCES ARE CONSISTENT WITH AN ENTEROCUTANEOUS FISTULA, STATUS POST PREVIOUS REPAIR OF ABDOMINAL HERNIA. GROSS DESCRIPTION: LABELLED \"HERNIA SAC, SEGMENT OF SMALL BOWEL\". \u00bfRECEIVED IN FORMALIN IS AN 18.0 X 4.0 CM ELLIPSE OF TAN HAIRLESS SKIN WITH TWO STELLATE SHAPED RETRACTED SCARS MEASURING 2.0 CM EACH. THE SKIN ELLIPSE IS ATTACHED TO A 25.0 X 19.0 CM FIBROUS AND MEMBRANOUS TISSUE RANGING IN THICKNESS FROM 1.3 X 0.3 CM. MULTIPLE ATTACHED UNREMARKABLE FATTY LOBULES ARE ALSO IDENTIFIED. THE FIBROMEMBRANOUS TISSUE IS INTERMIXED WITH A MESH WITH MULTIPLE SURGICAL STITCHES EMBEDDED INTO DENSE FIBROUS TISSUE. SIX ADDITIONAL PIECES OF FIBROUS TISSUE WITH SURGICAL STITCHES INTERMIXED WITH PIECES OF MESH ARE ALSO RECEIVED, AVERAGING IN SIZE FROM 4.0 X 2.5 X 0.4 CM, TO 13.0 X 4.5 X 0.5 CM. A 1.1 CM LONG X 2.6 CM IN DIAMETER DONUT SHAPED SEGMENT OF BOWEL IS ALSO IDENTIFIED. THE MUCOSAL SURFACE IS TAN AND EDEMATOUS WITHOUT DISTINCT LESIONS. THE WALL MEASURES 0.3 CM AND REVEALS AN UNREMARKABLE MUSCULARIS PROPRIA WITH SURROUNDING HEMORRHAGIC SOFT TISSUES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: 1 - SEGMENT OF BOWEL, TWO PIECES. 2 - SKIN WITH SCAR, ONE SECTION. 3 - FIBROMEMBRANOUS TISSUE, TWO PIECES. 4 - FIBROMEMBRANOUS TISSUE, TWO PIECES.\u00bf IMPLANT #2, #3, #4 PREOPERATIVE COMPLAINTS: NO INFORMATION. IMPLANT #2, #3, #4 PROCEDURE: LAPAROSCOPIC LYSIS OF ADHESIONS AND INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH. IMPLANT: GORE\u00ae DUALMESH\u00ae BIOMATERIAL X 3 [1DLMC07/00668394, 20X30CM; 1DLMC07/00604719, 20X30CM; 1DLMC03/00670141, 10X15CM]. IMPLANT #2, #3, #4 DATE: ON (B)(6) 2001 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 2001 [DICTATION DATE: ON (B)(6) 2001]: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: MULTIPLE RECURRENT INCISIONAL HERNIAS. ANESTHESIA: GENERAL. PROCEDURE: \u00bfTHE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION AND AFTER THE ADMINISTRATION OF GENERAL ENDOTRACHEAL ANESTHESIA, THE ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. A STERI-DRAPE WAS USED FOR THIS AND THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS. VENODYNE BOOTS WERE PLACED AND A FOLEY CATHETER AND AN OROGASTRIC TUBE WERE INSERTED. THE PERITONEAL CAVITY WAS ACCESSED USING AN OPEN TECHNIQUE. THE ABDOMEN WAS INSUFFLATED TO 12 MMHG WITH C02. ADDITIONAL WORKING PORTS WERE PLACED AND THERE WAS NOTED TO BE NUMEROUS, DENSE ADHESIONS BETWEEN THE LIVER AND THE ABDOMINAL WALL, AS WELL AS BETWEEN THE BOWEL AND OMENTUM AND ABDOMINAL WALL. THIS WAS A PAINSTAKING LYSIS OF ADHESIONS. IT TOOK A CONSIDERABLE AMOUNT OF TIME AND WAS VERY DIFFICULT. DESPITE THIS, THIS WAS SAFELY PERFORMED WITH METICULOUS SURGICAL TECHNIQUE. WE USED MINIMAL CAUTERY FOR THIS PORTION OF THE OPERATION. ONCE WE EXPOSED THE ABDOMINAL WALL, THERE WAS A 2 X 2 CM PERIUMBILICAL DEFECT AND A 17 X 17 CM DEFECT JUST TO THE LEFT OF THE MIDLINE AT THE COSTAL MARGIN. IN ORDER TO COMPLETELY COVER THE DEFECT, AS WELL AS THE ENTIRE MIDLINE INCISION, WE PLACED A 20 X 30 MESH TRANSVERSELY UP UNDER THE LEFT COSTAL MARGIN AND A 20 X 30 MESH PLACED LONGITUDINALLY TO COVER THE PERIUMBILICAL DEFECT IN THE ENTIRE OLD INCISION. THE LEFT LOWER PORTION OF THE 17 X 17 CM DEFECT WAS CLOSE SO WE ADDED AN ADDITIONAL 10 X 15 CM PATCH TO SECURE THIS CORNER. THE COMBINATION OF MESHES WERE SECURED WITH 11 FULL THICKNESS CV2 GORE-TEX SUTURES AND TACKS AROUND THE PERIPHERY. THE MESH EXTENDED UP TO THE XIPHOID PROCESS AND CLEARLY ABOVE THE LEFT COSTAL MARGIN GIVING US ADEQUATE OVERLAP AROUND ALL ASPECTS OF THE DEFECTS AND COVERING COMPLETELY THE OLD INCISIONS. THE PORTS WERE ALL REMOVED AND THE C02 WAS ALLOWED TO ESCAPE. THE SKIN WAS CLOSED IN A STANDARD FASHION WITH SUBCUTICULAR MONOCRYL AND STERI-STRIPS. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. ESTIMATED BLOOD LOSS WAS MINIMAL. SHE WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION.\u00bf ON (B)(6) 2001: (B)(6) CENTER. IMPLANT STICKERS. 1. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC07. LOT#: 00668394. 2. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC07. LOT#: 00604719. 3. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC03. LOT#: 00670141. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2002: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: PERIRECTAL AND ISCHIORECTAL ABSCESS. INFECTED SEBACEOUS CYST OF THE FACE. PROCEDURE: INCISION AND DRAINAGE OF ISCHIORECTAL ABSCESS. EXCISION OF INFECTED SEBACEOUS CYST OF THE FACE, 1-2 CM. RIGID SIGMOIDOSCOPY. FINDINGS: \u00bfTHE PATIENT HAD AN EXTENSIVE ABSCESS THAT EXTENDED ALONG THE LEFT SIDE OF THE RECTUM AND UNDER THE LEVATORS. IT WENT AROUND THE MIDLINE POSTERIORLY, AND ANTERIORLY IT WENT TO THE COOPER'S LIGAMENT AND PUBIS. LATERALLY IT EXTENDED INTO THE GLUTEUS. IT HAD VERY FOUL SMELLING ODOR. SURPRISINGLY, THE TISSUES OF THE CAVITY DID NOT SHOW ANY NECROSIS. RIGID SIGMOIDOSCOPY UP TO 20 CM DID NOT SHOW ANY OBVIOUS CANCER. I DID SEE SOME DIVERTICULA, BUT I DID NOT SEE ANY INFLAMMATION.\u00bf ON (B)(6) 2002: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: EXTENSIVE PERIRECTAL ABSCESS. PROCEDURE: DRESSING CHANGES UNDER ANESTHESIA. FINDINGS: \u00bfTHERE WAS STILL PURULENT FLUID DEEP IN THE CAVITY OF THE ABSCESS, ONE EXTENDING BELOW THE LEVATORS AND AROUND THE AREA OF THE COOPER'S LIGAMENT AND PUBIS. THE TISSUES WERE ACTUALLY FAIRLY VIABLE EXCEPT FOR THE MOST SUPERFICIAL PART THAT SHOWED SOME SUPERFICIAL BLACK NECROSIS OF THE CONNECTIVE TISSUE. THERE WAS NO OBVIOUS FISTULA CONNECTING WITH THE RECTUM.\u00bf ON (B)(6) 2011:(B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: INFRARENAL ABDOMINAL AORTIC ANEURYSM. PROCEDURE: ENDOVASCULAR ANEURYSM REPAIR WITH GORE EXCLUDER C3 GRAFT. CUT-DOWNS WERE PERFORMED ON BOTH GROINS. ON (B)(6) 2011: (B)(6), MD. IMPLANT RECORD. EXCLUDER. IMPLANT SITE: AORTA. EXCLUDER. IMPLANT SITE: RIGHT COMMON ILIAC ARTERY." }, { "mdr_text_key": "205271207", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\"" }, { "mdr_text_key": "205271208", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT MULTIPLE OPEN INCISIONAL HERNIA REPAIRS ON (B)(6) 1999 AND (B)(6) 2001 WHEREBY A GORE-TEX\u00ae SOFT TISSUE PATCH AND GORE\u00ae DUALMESH\u00ae BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2000 AND (B)(6) 2016, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF PREVIOUS GORE MESH, REMOVAL OF SMALL BOWEL FISTULA, RESECTION OF SMALL BOWEL DUE TO FISTULA, RECURRENT VENTRAL INCISIONAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH, ABDOMINAL WOUND DRAINAGE, SEVERE PAIN, DEBRIDEMENT OF NON-HEALING OPEN WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3750 W. KILTIE LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86004", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/11/2020;04/01/2021;03/13/2023" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FLAGSTAFF", "manufacturer_contact_address_1": "1505 N. FOURTH STREET", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "2017233-2020-01201", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "K992189", "date_of_event": "20000414", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "86004", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "WOMBLE", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "86005", "manufacturer_g1_state": "AZ", "reporter_country_code": "US", "manufacturer_contact_area_code": "928", "date_added": "20200901", "manufacturer_contact_f_name": "HEIDI", "device_date_of_manufacturer": "20001208", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "GORE\u00ae DUALMESH\u00ae BIOMATERIAL", "generic_name": "MESH, SURGICAL, POLYMERIC", "manufacturer_d_name": "W. L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "1505 N. FOURTH STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86004", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86004", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20051207", "model_number": "1DLMC07", "catalog_number": "1DLMC07", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FTL", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00733132601004", "udi_public": "00733132601004", "openfda": { "device_name": "Mesh, Surgical, Polymeric", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/14/2020;02/24/2021;02/24/2021", "manufacturer_contact_country": "US", "date_changed": "20240202", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "42 YR", "patient_sex": "Male", "patient_weight": "77 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230313", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "10480150", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200814", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "86005", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL WOODY MOUNTAIN B/P", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321972693", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT #1 PREOPERATIVE COMPLAINTS: ON (B)(6) 1999: (B)(6), MD. INDICATIONS: \u00bfMRS. (B)(6) HAD SEVERAL VENTRAL INCISIONAL HERNIA REPAIRS IN THE PAST. SHE HAS MORBID OBESITY AND SHE STATES FOR THE PAST TWO MONTHS SHE HAS BEEN HAVING PAIN JUST ABOVE THE UMBILICUS AND SHE HAS SOME NAUSEA, AND NO VOMITING, AND NO SYMPTOMS SUGGESTIVE OF STRANGULATION. SHE HAD A CT SCAN OF WHICH SHOWED A VENTRAL INCISIONAL HERNIA ABOVE THE UMBILICUS WITH THE LOOP OF SMALL BOWEL CAUGHT IN THE SAC. REPAIR WAS DISCUSSED WITH THE PATIENT. SHE UNDERSTOOD AND AGREED. I ALSO EXPLAINED TO HER THAT SHE IS PROBABLY GOING TO NEED SURGERY FOR GASTRIC STAPLING IN THE FUTURE TO DECREASE HER MORBID OBESITY.\u00bf IMPLANT #1 PROCEDURE: REPAIR RECURRENT VENTRAL INCISIONAL HERNIA USING GORE-TEX MESH AND LYSIS OF ADHESIONS. IMPLANT: GORE-TEX\u00ae SOFT TISSUE PATCH [1410015010/P13344-039]. IMPLANT #1 DATE: ON (B)(6) 1999 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 1999: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL INCISIONAL HERNIA. PROCEDURE: \u00bfUNDER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA WITH THE PATIENT IN THE SUPINE POSITION, THE SKIN OVER THE ENTIRE ABDOMEN WAS PREPPED WITH BETADINE SCRUB SOLUTION AND STERILE DRAPES WERE THEN APPLIED. AN ELLIPTICAL INCISION OF THE OLD SCAR OVER THE DISTAL THIRD OF THE PREVIOUS SCAR WAS THEN CARRIED OUT THROUGH SKIN AND SUBCUTANEOUSLY AND BLEEDERS WERE CLAMPED AND CAUTERIZED. IT WAS EVIDENT THAT THE PATIENT HAD A HERNIAL SAC OF WHICH WAS COMING OUT OF THE LOWER PART OF THE END OF AN OLD PROLENE MESH WHICH HAD COME OFF FROM THE FASCIAL SIDE. THIS HERNIAL SAC WAS THEN DISSECTED OFF DOWN TO THE OPENING OF THE FASCIA AND THE MESH AND THE SAC WAS OPENED, AND IT CONTAINED A LOOP OF SMALL BOWEL WHICH WAS THEN FREED UP FROM THE SAC WITHOUT DIFFICULTY. SOME OF THE MESH WAS REMOVED; THE ONE ATTACHED TO THE FASCIA, AND THERE WAS A DEFECT OF APPROXIMATELY 8 BY 6 CM IN DIAMETER. THERE WAS NO OTHER LOOPS OF BOWEL CAUGHT IN THE AREA. THE OMENTUM WAS THEN FREED UP FROM THE ANTERIOR ABDOMINAL WALL SO THAT WE COULD COVER THE BOWELS WELL TO PREVENT CONTACT BETWEEN THE BOWEL AND MESH ITSELF. A GORE-TEX MESH WAS THEN FASHIONED AND MEASURING ABOUT AT LEAST 10 BY 8 CM AND WAS THEN SUTURED TO THE EDGES OF THE FASCIAL DEFECT AND THE DEFECT ON THE OLD PROLENE MESH, CHOOSING A GOOD REINFORCEMENT OF THE POSTERIOR ABDOMINAL WALL. THE FASCIA WAS CLOSED PARTIALLY ON TOP OF THE GORE-TEX MESH USING A RUNNING SUTURE OF ABOUT #0 NOVOFIL. HEMOSTASIS WAS ACHIEVED AND EXCELLENT. THE SUBCUTANEOUS TISSUES WAS [SIC] THEN CLOSED WITH INTERRUPTED SUTURES OF #3-0 DEXON AND DECIDED NOT TO USE ANY DRAINS. THE SKIN WAS THEN CLOSED WITH SURGICAL STAPLES. A COMPRESSIVE DRY STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.\u00bf ON (B)(6) 1999: (B)(6) CENTER. IMPLANT STICKER. \u00bfGORE-TEX SOFT TISSUE PATCH\u00bf. ITEM#: 1410015010. LOT#: P13344-039. ON (B)(6) 1999: (B)(6), MD. PATHOLOGY REPORT. DIAGNOSIS: SOFT TISSUE, ABDOMINAL WALL, HERNIORRHAPHY: DENSE FIBROVASCULAR CONNECTIVE TISSUE AND FIBROADIPOSE TISSUE, WITH SUTURE GRANULOMA (CLINICALLY, RECURRENT VENTRAL HERNIA). TISSUE SOURCE: ABDOMINAL WALL. GROSS DESCRIPTION: \u00bfRECEIVED IN FORMALIN LABELLED \u00bfABDOMINAL WALL\u00bf IS A MOTTLED WHITE PINK TO TAN YELLOW FOCALLY CAUTERIZED RUBBERY TISSUE RANGING FROM 1.8 X 1.6 X 0.6 CM TO 6.5 X 2.0 X 1.2 CM. SEVERAL OF THE TISSUES DISPLAY BLUE SYNTHETIC SUTURE MATERIAL. REPRESENTATIVE SECTIONS ARE SUBMITTED LABELLED 1 AND 2.\u00bf RELEVANT MEDICAL INFORMATION: ON (B)(6) 2000: (B)(6), MD. ASSISTANT: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: MORBID OBESITY. VERTICAL BANDED GASTROPLASTY. IMPLANT: TRELEX NATURAL MESH. INDICATIONS: \u00bfTHE PATIENT IS A 41 YEAR OLD FEMALE WITH A HISTORY OF MORBID OBESITY WHOSE PAST SURGICAL HISTORY INCLUDED EXPLORATORY LAPAROTOMY AND OPEN CHOLECYSTECTOMY. THE PATIENT'S HISTORY ALSO INCLUDED RECURRENT VENTRAL HERNIAS WHICH HAVE BEEN REPAIRED MULTIPLE TIMES WITH MESH. AS THE PATIENT'S STATUS IS CURRENTLY, SHE HAS A LARGE VENTRAL DEFECT WHICH SHOWS NO SIGNS OF INCARCERATION. IN ADDITION, THE PATIENT HAS A SINGLE DRAINING SINUS PRESUMABLY FROM COLONIZED MESH WHICH STILL REMAINS IN PLACE AND THE PATIENT DRAINS CONSTANT AMOUNTS OF SEROPURULENT MATERIAL FROM A SMALL OPENING IN HER ANTERIOR ABDOMINAL WALL. SHE IS FOLLOWED BY DR. (B)(6) FOR THESE MULTIPLE HERNIAS. AT THIS POINT, THE PATIENT'S WEIGHT / HEIGHT RATIO BMI IS 40 AND DESPITE MULTIPLE ATTEMPTS AT LIFESTYLE CHANGES AND DIETING, THE PATIENT HAS HAD NO LUCK AT WEIGHT LOSS. THE PATIENT UNDERSTANDS THE RISKS OF THE PROCEDURE AND THE FACT THAT THE ENTIRE PROCEDURE MAY NOT BE COMPLETED SECONDARY TO THE SIZE OF HER VENTRAL HERNIA AND POSSIBLE INVOLVEMENT OF SMALL BOWEL. NO ATTEMPT WILL BE MADE AT VENTRAL HERNIA REPAIR OR RESECTION OF ANY MESH.\u00bf FINDINGS: \u00bfTHIS 41 YEAR OLD MORBIDLY OBESE FEMALE WITH A HISTORY OF SEVERAL VENTRAL HERNIA REPAIRS AFTER OPEN CHOLECYSTECTOMY UNDERWENT A VERTICAL BANDED GASTROPLASTY. THE BYPASS PORTION OF THE PROCEDURE COULD NOT BE COMPLETED SECONDARY TO THE ADHERENCE OF HER SMALL BOWEL WITHIN HER ABDOMEN WITH ADHESIONS AND POSSIBLE INVOLVEMENT IN A MASSIVE VENTRAL HERNIA. AS DISCUSSED WITH THE PATIENT PREOPERATIVELY, THE RISK OF REPAIR OF THIS HERNIA WITH INFECTED MESH WAS TOO GREAT TO JUSTIFY CONTINUING THE BYPASS PROCEDURE IN THIS CASE.\u00bf PROCEDURE: \u00bfWITH THE PATIENT LYING SUPINE AND ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA ADMINISTERED, THE PATIENT'S ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE MASSIVE DEFECT IN THE PATIENT'S VENTRAL HERNIA WAS APPRECIATED PREOPERATIVELY AND A LEFT SUBCOSTAL INCISION WAS MADE MEASURING APPROXIMATELY 15 CM LONG IN THE PATIENT'S LEFT UPPER QUADRANT. THIS WAS CARRIED DOWN TO THE SOFT TISSUE AND THE ANTERIOR AND POSTERIOR SHEATHS OF THE RECTUS MUSCLE AND THE PERITONEAL CAVITY WAS ENTERED WITHOUT INJURY TO UNDERLYING STRUCTURES. IT BECAME QUITE OBVIOUS WITH THE LYSIS OF SEVERAL ADHESIONS THAT THE STOMACH WAS INDEED REACHABLE AND THE GASTRIC PORTION OF THE PROCEDURE COULD BE UNDERTAKEN. HOWEVER, IT WAS NOTED DUE TO MASSIVE ADHESIONS AND BOWEL WITHIN THIS LARGE VENTRAL DEFECT THAT ONLY APPROXIMATELY 70 CM OF SMALL BOWEL COULD BE REACHED AND WORKED ON. AS DISCUSSED WITH THE PATIENT PREOPERATIVELY, THE INTRAOPERATIVE DECISION WAS MADE NOT TO TRY TO REDUCE OR REPAIR ANY OF THIS HERNIA GIVEN THE FACT THAT THERE WAS MESH WITH SOME PORTIONS OF INFECTED MESH PRESENT. FOR THIS REASON, THE INTRAOPERATIVE DECISION TO ONLY DO THE VERTICAL BANDED GASTROPLASTY WITHOUT THE BYPASS WAS MADE. THE STOMACH WAS MOBILIZED ALONG THE LESSER CURVATURE AND ALSO THE GASTROESOPHAGEAL JUNCTION ISOLATED AND SURROUNDED WITH THE PENROSE DRAIN. ALONG THE LESSER CURVATURE OF THE STOMACH, APPROXIMATELY 10 CM FROM THE GASTROESOPHAGEAL JUNCTION, AN EEA STAPLER WAS PASSED THROUGH THE ANTERIOR WALL EXITING THE POSTERIOR WALL OF THE STOMACH AND WAS FIRED CREATING AN APPROXIMATELY 2 CM DIAMETER HOLE DIRECTLY IN THE STOMACH. THE LESSER SAC WAS FREED OF ALL ADHESIONS AND SERIAL GIA STAPLERS WERE USED TO TRANSECT FROM THE POINT OF THIS CIRCULAR OPENING TO THE LATERAL EDGE OF THE GASTROESOPHAGEAL JUNCTION. AN ESOPHAGEAL STENT WAS IN PLACE TO ASSURE AN ADEQUATE POUCH WAS CREATED. THE STAPLE LINES OF THE GIA WERE THEN OVERSEWN WITH INTERRUPTED AND RUNNING SILK SUTURES. A PROLENE MESH BAND WAS THEN CREATED AT THE DISTAL END OF THE POUCH AND SUTURED LOOSELY AROUND THE DISTAL END. THE ABDOMEN WAS THOROUGHLY IRRIGATED. GOOD HEMOSTASIS WAS NOTED. THE ABDOMEN WAS THEN CLOSED IN MULTIPLE LAYERS WITH A LAYER OF RUNNING VICRYL SUTURE IN THE POSTERIOR SHEATH, ANTERIOR SHEATH, SCARPA'S AND INTERRUPTED VICRYL SUTURES IN THE DERMAL LAYER. THE SKIN WAS THEN CLOSED WITH STAPLES AND A DRY, STERILE DRESSING APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS THE EXTUBATED AND STABLE TO THE POST ANESTHESIA CARE UNIT.\u00bf EXPLANT #1 PREOPERATIVE COMPLAINTS: ON (B)(6) 2000: (B)(6), MD. INDICATIONS: \u00bfTHIS PATIENT HAS HAD MULTIPLE VENTRAL HERNIAS IN THE PAST AND SHE IS MASSIVELY OBESE. SHE RECENTLY UNDERWENT A GASTROPLASTY BECAUSE OF HER INABILITY TO LOSE WEIGHT AND THE FACT THAT SHE HAS A RECURRENT HERNIA DUE TO INCREASED OBESITY. POSTOPERATIVELY AFTER THE GASTROPLASTY, SHE DEVELOPED A WOUND INFECTION WHICH WAS OPENED AND DRAINED BY DR. (B)(6) AND SHE ALSO DEVELOPED A FISTULA OF THE MID PORTION OF THE WOUND OF THE PREVIOUS HERNIA WHICH HAD BEEN PRESENT OFF AND ON BEFORE. THE IMPRESSION WAS THAT SHE HAD A SMALL BOWEL FISTULA AND SHE IS NOW ADMITTED BECAUSE OF INCREASED PAIN AND INCREASED DRAINAGE FROM THE MID PORTION OF THE WOUND ON THE MID LINE.\u00bf EXPLANT #1 PROCEDURE: REPAIR OF MASSIVE VENTRAL INCISIONAL HERNIA WITH REPAIR OF SMALL BOWEL FISTULA BY DOING ENTEROENTEROSTOMY AND APPLICATION OF DEXON MESH OVER THE REPAIRED HERNIA. EXPLANT GORE-TEX. EXPLANT #1 DATE: ON (B)(6) 2000 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 2000: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: LARGE VENTRAL INCISIONAL HERNIA AND SMALL BOWEL FISTULA. ANESTHESIA: GENERAL. PROCEDURE: \u00bfUNDER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA AND WITH THE PATIENT IN THE SUPINE POSITION, THE SKIN OF THE ENTIRE ABDOMEN WAS PREPPED WITH BETADINE SCRUB AND SOLUTION. STERILE DRAPES WERE THEN APPLIED AND AN INCISION WAS THEN MADE AROUND THE OLD SURGICAL SCAR AND ON THAT INCLUDED THE PART WHERE THERE WAS A FISTULA ON THE MID PORTION OF THE MID LINE UPPER ABDOMEN AND AROUND THE UMBILICUS. THE INCISION WAS THEN DEEPENED THROUGH SKIN AND SUBCUTANEOUS TISSUE. IT WAS EVIDENT THAT THE PATIENT HAD A BIG COLLECTION OF FLUID ON THE LEFT SIDE OF THE OLD SCAR WHICH WAS CONSISTENT WITH SMALL BOWEL CONTENTS AND A SPECIMEN OF THAT WAS TAKEN FOR CULTURE AND SENSITIVITY. WE THEN PROCEEDED BY RESECTING THE ENTIRE SCAR AND SENDING IT OUT TO PATHOLOGY. THE PATIENT HAD A VERY LARGE VENTRAL INCISIONAL HERNIA WHICH CONTAINED THE OLD PROLENE MESH, AS WELL AS A GORE-TEX MESH AND ALL THE OLD MESH OF PROLENE, AS WELL AS THE GORE-TEX MESH WAS REMOVED AND SENT TO PATHOLOGY. ASSOCIATED WITH THIS SCAR WERE THE BORDERS OF THE FASCIA WHICH ALSO CONTAINED SMALL SEGMENT OF THE SMALL BOWEL WHICH WAS DEEPLY ADHERENT TO THE SCAR WITH THE SMALL BOWEL FISTULA. I HAD TO RESECT A PART OF THE SMALL BOWEL WHICH WAS THE CAUSE OF HER SMALL BOWEL FISTULA. WITH THIS DONE, THEN THE BORDERS OF THE FASCIA WERE REFRESHED AND UNTIL COMPLETELY NORMAL TISSUE AND ALL THE SCAR TISSUE, AS WELL AS THE MESH HAD BEEN REMOVED AND SENT TO PATHOLOGY. WITH THIS DONE, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED WITH SALINE AND DRIED AND EXAMINATION OF THE ENTIRE CAVITY REVEALED TO BE NORMAL. I COULD NOT FIND ANY DEFINITE STONES IN THE GALLBLADDER. THERE WERE ADHESIONS IN THE LEFT UPPER QUADRANT FROM THE PREVIOUS GASTROPLASTY AND I DID NOT ENTER IN THAT AREA. THERE WAS NO EVIDENCE OF INTRAABDOMINAL ABSCESS AND THE ENTIRE SMALL BOWEL WAS RUN FROM THE LIGAMENT OF TREITZ ALL THE WAY DOWN TO THE ILEOCECAL VALVE REVEALING ONLY THIS DEFECT OF THE SMALL BOWEL WHICH WAS THE AREA WHICH WAS CAUSING THE SMALL BOWEL FISTULA. AT THIS STAGE, I DECIDED TO REPAIR THIS SMALL BOWEL FISTULA BY BRINGING THE TWO LOOPS OF THE PROXIMAL DISTAL END OF THE BOWEL AROUND THE AREA OF THE DEFECT ON THE ANTERIOR WALL OF THE BOWEL AND I DID INSERT A GIA THROUGH THESE TWO OPENINGS IN THE PROXIMAL AND DISTAL ENDS OF THE BOWEL AND SIDE-TO-SIDE (PROXIMAL END) FUNCTIONAL END-TO-END ANASTOMOSIS WAS THEN CARRIED OUT. THE GIA STAPLER WAS APPLIED AND FIRED AND THE OPENING OF THE BOWEL WAS THEN CLOSED USING TA-55 ACHIEVING EXCELLENT LUMEN OF THE BOWEL AND WITH A GOOD BLOOD SUPPLY AND NO EVIDENCE OF ANY TENSION. WITH THIS DONE, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED WITH SALINE AND DRIED AND TO HAVE A COMPLETELY CLEAN RETURN. THE FASCIAL DEFECT MEASURED ABOUT 15 X 10 CM. AT THIS STAGE I FELT THAT SINCE THERE WAS A SMALL BOWEL FISTULA THAT I WOULD NOT USE NONABSORBABLE MESH TO CLOSE THE FASCIAL DEFECT BECAUSE I WAS AFRAID THAT THIS WOULD BE CONTAMINATED WITH THE SMALL BOWEL CONTENTS AND IT COULD CAUSE PERSISTENT INFECTION ON THE WOUND AND ALSO COULD IN THE FUTURE CAUSE RECURRENT HERNIA DUE TO INFECTION. SO I FELT THAT AT BEST, EVEN THOUGH THERE WOULD BE SOME SMALL AMOUNT OF TENSION ON THE WOUND, WAS TO CLOSE THE WOUND IN ONE LAYER USING A RUNNING SUTURE OF #2 ETHILON BRINGING THE ANTERIOR AND POSTERIOR FASCIA, AS WELL AS PERITONEUM. THIS WAS DONE IN SHORT RUNS OF CONTINUOUS SUTURE WITH #2 NYLON AND ACHIEVING, ALTHOUGH THERE WAS A LITTLE BIT OF TENSION, A GOOD CLOSURE OF THE FASCIA DEFECT AND THE ENTIRE WOUND. I HAVE TO ADD THAT THERE WERE MULTIPLE OTHER DEFECTS ON THE MIDLINE ON THE UPPER PART OF THE INCISION. I WAS PRETTY SATISFIED WITH THE CLOSURE AND ON TOP OF THAT THEN I DID PUT A PIECE OF DEXON MESH REINFORCING THIS WHICH IS AN ABSORBABLE MESH AND THIS WAS THEN SUTURED OVER THE FASCIA USING A RUNNING SUTURE OF #2-0 PROLENE ACHIEVING A GOOD REINFORCEMENT OF THE FASCIAL CLOSURE. THE SUBCUTANEOUS WAS THEN CLOSED WITH INTERRUPTED SUTURES OF #3-0 DEXON. THE SKIN WAS CLOSED WITH SURGICAL STAPLES. I DID PUT A JACKSON-PRATT DRAIN IN THE WOUND AND BROUGHT IT OUT THROUGH A SEPARATE STAB WOUND IN THE LOWER PART OF THE ABDOMEN. THIS JACKSON-PRATT DRAIN WAS SUTURED IN PLACE WITH A #4-0 NYLON. A COMPRESSIVE DRY, STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL. I HAVE TO ADD THAT THERE WERE NO OTHER ABNORMALITIES IN THE SMALL BOWEL BESIDES THE ONE IN THE AREA THAT WAS CAUSING THE FISTULA AND THE ENTIRE LARGE BOWEL WAS INSPECTED FROM THE CECUM ALL THE WAY DOWN TO THE RECTOSIGMOID AND THAT DID NOT SHOW EVIDENCE OF A MASS AND NO EVIDENCE OF DIVERTICULITIS, BUT A FEW DIVERTICULA AND PALPATION OF THE UTERUS AND THE OVARIES DID NOT REVEAL ANY EVIDENCE OF A MASS. THEY WERE OF NORMAL SIZE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.\u00bf ON (B)(6) 2000: (B)(6), MD. PATHOLOGY REPORT. TISSUE SOURCE: HERNIA SAC SEGMENT OF SMALL BOWEL. DIAGNOSIS: LABELED \u00bfHERNIA SAC AND SEGMENT OF SMALL BOWEL\u00bf. HEMORRHAGIC MUCOSAL NECROSIS, SMALL INTESTINE WITH ADHESION TO FASCIA AND SKIN AT SITE OF HERNIA REPAIR. NOTE: SEGMENT OF SMALL BOWEL APPEARS TO BE ADHERENT TO FASCIA AS WELL AS FIBROADIPOSE TISSUE AND SKIN AT THE SITE OF MESH PLACEMENT AND DERMAL SCAR. APPEARANCES ARE CONSISTENT WITH AN ENTEROCUTANEOUS FISTULA, STATUS POST PREVIOUS REPAIR OF ABDOMINAL HERNIA. GROSS DESCRIPTION: LABELLED \"HERNIA SAC, SEGMENT OF SMALL BOWEL\". \u00bfRECEIVED IN FORMALIN IS AN 18.0 X 4.0 CM ELLIPSE OF TAN HAIRLESS SKIN WITH TWO STELLATE SHAPED RETRACTED SCARS MEASURING 2.0 CM EACH. THE SKIN ELLIPSE IS ATTACHED TO A 25.0 X 19.0 CM FIBROUS AND MEMBRANOUS TISSUE RANGING IN THICKNESS FROM 1.3 X 0.3 CM. MULTIPLE ATTACHED UNREMARKABLE FATTY LOBULES ARE ALSO IDENTIFIED. THE FIBROMEMBRANOUS TISSUE IS INTERMIXED WITH A MESH WITH MULTIPLE SURGICAL STITCHES EMBEDDED INTO DENSE FIBROUS TISSUE. SIX ADDITIONAL PIECES OF FIBROUS TISSUE WITH SURGICAL STITCHES INTERMIXED WITH PIECES OF MESH ARE ALSO RECEIVED, AVERAGING IN SIZE FROM 4.0 X 2.5 X 0.4 CM, TO 13.0 X 4.5 X 0.5 CM. A 1.1 CM LONG X 2.6 CM IN DIAMETER DONUT SHAPED SEGMENT OF BOWEL IS ALSO IDENTIFIED. THE MUCOSAL SURFACE IS TAN AND EDEMATOUS WITHOUT DISTINCT LESIONS. THE WALL MEASURES 0.3 CM AND REVEALS AN UNREMARKABLE MUSCULARIS PROPRIA WITH SURROUNDING HEMORRHAGIC SOFT TISSUES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: 1 - SEGMENT OF BOWEL, TWO PIECES. 2 - SKIN WITH SCAR, ONE SECTION. 3 - FIBROMEMBRANOUS TISSUE, TWO PIECES. 4 - FIBROMEMBRANOUS TISSUE, TWO PIECES.\u00bf IMPLANT #2, #3, #4 PREOPERATIVE COMPLAINTS: NO INFORMATION. IMPLANT #2, #3, #4 PROCEDURE: LAPAROSCOPIC LYSIS OF ADHESIONS AND INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH. IMPLANT: GORE\u00ae DUALMESH\u00ae BIOMATERIAL X 3 [1DLMC07/00668394, 20X30CM; 1DLMC07/00604719, 20X30CM; 1DLMC03/00670141, 10X15CM] IMPLANT #2, #3, #4 DATE: ON (B)(6) 2001 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 2001 [DICTATION DATE: ON (B)(6) 2001]: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: MULTIPLE RECURRENT INCISIONAL HERNIAS. ANESTHESIA: GENERAL. PROCEDURE: \u00bfTHE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION AND AFTER THE ADMINISTRATION OF GENERAL ENDOTRACHEAL ANESTHESIA, THE ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. A STERI-DRAPE WAS USED FOR THIS AND THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS. VENODYNE BOOTS WERE PLACED AND A FOLEY CATHETER AND AN OROGASTRIC TUBE WERE INSERTED. THE PERITONEAL CAVITY WAS ACCESSED USING AN OPEN TECHNIQUE. THE ABDOMEN WAS INSUFFLATED TO 12 MMHG WITH C02. ADDITIONAL WORKING PORTS WERE PLACED AND THERE WAS NOTED TO BE NUMEROUS, DENSE ADHESIONS BETWEEN THE LIVER AND THE ABDOMINAL WALL, AS WELL AS BETWEEN THE BOWEL AND OMENTUM AND ABDOMINAL WALL. THIS WAS A PAINSTAKING LYSIS OF ADHESIONS. IT TOOK A CONSIDERABLE AMOUNT OF TIME AND WAS VERY DIFFICULT. DESPITE THIS, THIS WAS SAFELY PERFORMED WITH METICULOUS SURGICAL TECHNIQUE. WE USED MINIMAL CAUTERY FOR THIS PORTION OF THE OPERATION. ONCE WE EXPOSED THE ABDOMINAL WALL, THERE WAS A 2 X 2 CM PERIUMBILICAL DEFECT AND A 17 X 17 CM DEFECT JUST TO THE LEFT OF THE MIDLINE AT THE COSTAL MARGIN. IN ORDER TO COMPLETELY COVER THE DEFECT, AS WELL AS THE ENTIRE MIDLINE INCISION, WE PLACED A 20 X 30 MESH TRANSVERSELY UP UNDER THE LEFT COSTAL MARGIN AND A 20 X 30 MESH PLACED LONGITUDINALLY TO COVER THE PERIUMBILICAL DEFECT IN THE ENTIRE OLD INCISION. THE LEFT LOWER PORTION OF THE 17 X 17 CM DEFECT WAS CLOSE SO WE ADDED AN ADDITIONAL 10 X 15 CM PATCH TO SECURE THIS CORNER. THE COMBINATION OF MESHES WERE SECURED WITH 11 FULL THICKNESS CV2 GORE-TEX SUTURES AND TACKS AROUND THE PERIPHERY. THE MESH EXTENDED UP TO THE XIPHOID PROCESS AND CLEARLY ABOVE THE LEFT COSTAL MARGIN GIVING US ADEQUATE OVERLAP AROUND ALL ASPECTS OF THE DEFECTS AND COVERING COMPLETELY THE OLD INCISIONS. THE PORTS WERE ALL REMOVED AND THE C02 WAS ALLOWED TO ESCAPE. THE SKIN WAS CLOSED IN A STANDARD FASHION WITH SUBCUTICULAR MONOCRYL AND STERI-STRIPS. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. ESTIMATED BLOOD LOSS WAS MINIMAL. SHE WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION.\u00bf ON (B)(6) 2001: (B)(6) CENTER. IMPLANT STICKERS. 1. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC07. LOT#: 00668394. 2. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC07. LOT#: 00604719. 3. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC03. LOT#: 00670141. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2002: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: PERIRECTAL AND ISCHIORECTAL ABSCESS. INFECTED SEBACEOUS CYST OF THE FACE. PROCEDURE: INCISION AND DRAINAGE OF ISCHIORECTAL ABSCESS. EXCISION OF INFECTED SEBACEOUS CYST OF THE FACE, 1-2 CM. RIGID SIGMOIDOSCOPY. FINDINGS: \u00bfTHE PATIENT HAD AN EXTENSIVE ABSCESS THAT EXTENDED ALONG THE LEFT SIDE OF THE RECTUM AND UNDER THE LEVATORS. IT WENT AROUND THE MIDLINE POSTERIORLY, AND ANTERIORLY IT WENT TO THE COOPER'S LIGAMENT AND PUBIS. LATERALLY IT EXTENDED INTO THE GLUTEUS. IT HAD VERY FOUL SMELLING ODOR. SURPRISINGLY, THE TISSUES OF THE CAVITY DID NOT SHOW ANY NECROSIS. RIGID SIGMOIDOSCOPY UP TO 20 CM DID NOT SHOW ANY OBVIOUS CANCER. I DID SEE SOME DIVERTICULA, BUT I DID NOT SEE ANY INFLAMMATION.\u00bf ON (B)(6) 2002: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: EXTENSIVE PERIRECTAL ABSCESS. PROCEDURE: DRESSING CHANGES UNDER ANESTHESIA. FINDINGS: \u00bfTHERE WAS STILL PURULENT FLUID DEEP IN THE CAVITY OF THE ABSCESS, ONE EXTENDING BELOW THE LEVATORS AND AROUND THE AREA OF THE COOPER'S LIGAMENT AND PUBIS. THE TISSUES WERE ACTUALLY FAIRLY VIABLE EXCEPT FOR THE MOST SUPERFICIAL PART THAT SHOWED SOME SUPERFICIAL BLACK NECROSIS OF THE CONNECTIVE TISSUE. THERE WAS NO OBVIOUS FISTULA CONNECTING WITH THE RECTUM.\u00bf ON (B)(6) 2011: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: INFRARENAL ABDOMINAL AORTIC ANEURYSM. PROCEDURE: ENDOVASCULAR ANEURYSM REPAIR WITH GORE EXCLUDER C3 GRAFT. CUT-DOWNS WERE PERFORMED ON BOTH GROINS. ON (B)(6) 2011: (B)(6), MD. IMPLANT RECORD. EXCLUDER. IMPLANT SITE: AORTA. EXCLUDER. IMPLANT SITE: RIGHT COMMON ILIAC ARTERY." }, { "mdr_text_key": "334416039", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED HEALTH EFFECT\u00bf H6: UPDATED INVESTIGATION FINDING\u00bf H6: UPDATED INVESTIGATION CONCLUSIONS \u00bf\u00bf\u00bf \u00bf THE INVESTIGATION HAS BEEN COMPLETED.\u00bf BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. THROUGH GORE'S INVESTIGATION AND BASED ON THE AVAILABLE INFORMATION THERE IS NO\u00bfAVAILABLE\u00bfINFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO\u00bfDEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE.\u00bf\u00bfTHEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS\u00bfNO PROBLEM DETECTED. \u00bf PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE\u00bfS INVESTIGATION. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\u00bf\u00bf AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH.\u00bfTHESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT\u00bfS UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES.\u00bfTHE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS.\u00bf THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. \u00bf W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "324579104", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" \u00a0 THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "205315838", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\"" }, { "mdr_text_key": "205315839", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT MULTIPLE OPEN INCISIONAL HERNIA REPAIRS ON (B)(6) 1999 AND (B)(6) 2001 WHEREBY A GORE-TEX\u00ae SOFT TISSUE PATCH AND GORE\u00ae DUALMESH\u00ae BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2000 AND (B)(6) 2016, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF PREVIOUS GORE MESH, REMOVAL OF SMALL BOWEL FISTULA, RESECTION OF SMALL BOWEL DUE TO FISTULA, RECURRENT VENTRAL INCISIONAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH, ABDOMINAL WOUND DRAINAGE, SEVERE PAIN, DEBRIDEMENT OF NON-HEALING OPEN WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3750 W. KILTIE LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86004", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/11/2020;04/01/2021;03/13/2023" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FLAGSTAFF", "manufacturer_contact_address_1": "1505 N. FOURTH STREET", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "2017233-2020-01202", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200901", "manufacturer_address_2": "", "pma_pmn_number": "K992189", "date_of_event": "20000414", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "86004", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "WOMBLE", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "86005", "manufacturer_g1_state": "AZ", "reporter_country_code": "US", "manufacturer_contact_area_code": "928", "date_added": "20200901", "manufacturer_contact_f_name": "HEIDI", "device_date_of_manufacturer": "20010115", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200901", "brand_name": "GORE\u00ae DUALMESH\u00ae BIOMATERIAL", "generic_name": "MESH, SURGICAL, POLYMERIC", "manufacturer_d_name": "W. L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "1505 N. FOURTH STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86004", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86004", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20060114", "model_number": "1DLMC03", "catalog_number": "1DLMC03", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FTL", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00733132600960", "udi_public": "00733132600960", "openfda": { "device_name": "Mesh, Surgical, Polymeric", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/14/2020;08/14/2020;02/24/2021;02/24/2021", "manufacturer_contact_country": "US", "date_changed": "20240201", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200901", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "42 YR", "patient_sex": "Male", "patient_weight": "77 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230313", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "10480157", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200814", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "86005", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL WOODY MOUNTAIN B/P", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321263369", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: CONCLUSION CODE REMAINS UNCHANGED. ADDED ATTACHMENT FOR H10/11 CONTINUATION FOR REPORT # 2017233-2020-01202. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "334287405", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED HEALTH EFFECT. H6: UPDATED INVESTIGATION FINDING. H6: UPDATED INVESTIGATION CONCLUSIONS. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. THROUGH GORE'S INVESTIGATION AND BASED ON THE AVAILABLE INFORMATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS NO PROBLEM DETECTED. PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE\u00bfS INVESTIGATION. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\u00bf AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT MESH.\u00bfTHESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MESH MIGRATION, MESH CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION/RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT\u00bfS UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. THE DEVICE WAS NOT ABLE TO BE RETURNED TO GORE FOR EVALUATION; THEREFORE, A DIRECT PRODUCT ANALYSIS COULD NOT BE CONDUCTED. BASED ON MANUFACTURE DATE OF DEVICE, PRODUCT TRACKING UNAVAILABLE. REVIEW OF THE STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "324664811", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" \u00a0 THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "205283999", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT SHOULD BE NOTED THAT THE GORE\u00ae DUALMESH\u00ae BIOMATERIAL INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\"" }, { "mdr_text_key": "205284000", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT MULTIPLE OPEN INCISIONAL HERNIA REPAIRS ON (B)(6) 1999 AND (B)(6) 2001 WHEREBY A GORE-TEX\u00ae SOFT TISSUE PATCH AND GORE\u00ae DUALMESH\u00ae BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2000 AND (B)(6) 2016, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF PREVIOUS GORE MESH, REMOVAL OF SMALL BOWEL FISTULA, RESECTION OF SMALL BOWEL DUE TO FISTULA, RECURRENT VENTRAL INCISIONAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH, ABDOMINAL WOUND DRAINAGE, SEVERE PAIN, DEBRIDEMENT OF NON-HEALING OPEN WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED." }, { "mdr_text_key": "322427185", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: IMPLANT #1 PREOPERATIVE COMPLAINTS: ON (B)(6) 1999: (B)(6), MD. INDICATIONS: \u00bfMRS. (B)(6) HAD SEVERAL VENTRAL INCISIONAL HERNIA REPAIRS IN THE PAST. SHE HAS MORBID OBESITY AND SHE STATES FOR THE PAST TWO MONTHS SHE HAS BEEN HAVING PAIN JUST ABOVE THE UMBILICUS AND SHE HAS SOME NAUSEA, AND NO VOMITING, AND NO SYMPTOMS SUGGESTIVE OF STRANGULATION. SHE HAD A CT SCAN OF WHICH SHOWED A VENTRAL INCISIONAL HERNIA ABOVE THE UMBILICUS WITH THE LOOP OF SMALL BOWEL CAUGHT IN THE SAC. REPAIR WAS DISCUSSED WITH THE PATIENT. SHE UNDERSTOOD AND AGREED. I ALSO EXPLAINED TO HER THAT SHE IS PROBABLY GOING TO NEED SURGERY FOR GASTRIC STAPLING IN THE FUTURE TO DECREASE HER MORBID OBESITY.\u00bf IMPLANT #1 PROCEDURE: REPAIR RECURRENT VENTRAL INCISIONAL HERNIA USING GORE-TEX MESH AND LYSIS OF ADHESIONS. IMPLANT: GORE-TEX\u00ae SOFT TISSUE PATCH [1410015010 / P13344-039]. IMPLANT #1 DATE: ON (B)(6) 1999 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 1999: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: RECURRENT VENTRAL INCISIONAL HERNIA. PROCEDURE: \u00bfUNDER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA WITH THE PATIENT IN THE SUPINE POSITION, THE SKIN OVER THE ENTIRE ABDOMEN WAS PREPPED WITH BETADINE SCRUB SOLUTION AND STERILE DRAPES WERE THEN APPLIED. AN ELLIPTICAL INCISION OF THE OLD SCAR OVER THE DISTAL THIRD OF THE PREVIOUS SCAR WAS THEN CARRIED OUT THROUGH SKIN AND SUBCUTANEOUSLY AND BLEEDERS WERE CLAMPED AND CAUTERIZED. IT WAS EVIDENT THAT THE PATIENT HAD A HERNIAL SAC OF WHICH WAS COMING OUT OF THE LOWER PART OF THE END OF AN OLD PROLENE MESH WHICH HAD COME OFF FROM THE FASCIAL SIDE. THIS HERNIAL SAC WAS THEN DISSECTED OFF DOWN TO THE OPENING OF THE FASCIA AND THE MESH AND THE SAC WAS OPENED, AND IT CONTAINED A LOOP OF SMALL BOWEL WHICH WAS THEN FREED UP FROM THE SAC WITHOUT DIFFICULTY. SOME OF THE MESH WAS REMOVED; THE ONE ATTACHED TO THE FASCIA, AND THERE WAS A DEFECT OF APPROXIMATELY 8 BY 6 CM IN DIAMETER. THERE WAS NO OTHER LOOPS OF BOWEL CAUGHT IN THE AREA. THE OMENTUM WAS THEN FREED UP FROM THE ANTERIOR ABDOMINAL WALL SO THAT WE COULD COVER THE BOWELS WELL TO PREVENT CONTACT BETWEEN THE BOWEL AND MESH ITSELF. A GORE-TEX MESH WAS THEN FASHIONED AND MEASURING ABOUT AT LEAST 10 BY 8 CM AND WAS THEN SUTURED TO THE EDGES OF THE FASCIAL DEFECT AND THE DEFECT ON THE OLD PROLENE MESH, CHOOSING A GOOD REINFORCEMENT OF THE POSTERIOR ABDOMINAL WALL. THE FASCIA WAS CLOSED PARTIALLY ON TOP OF THE GORE-TEX MESH USING A RUNNING SUTURE OF ABOUT #0 NOVOFIL. HEMOSTASIS WAS ACHIEVED AND EXCELLENT. THE SUBCUTANEOUS TISSUES WAS [SIC] THEN CLOSED WITH INTERRUPTED SUTURES OF #3-0 DEXON AND DECIDED NOT TO USE ANY DRAINS. THE SKIN WAS THEN CLOSED WITH SURGICAL STAPLES. A COMPRESSIVE DRY STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.\u00bf ON (B)(6) 1999: (B)(6) CENTER. IMPLANT STICKER. \u00bfGORE-TEX SOFT TISSUE PATCH\u00bf. ITEM#: 1410015010. LOT#: P13344-039. ON (B)(6) 2099: (B)(6), MD. PATHOLOGY REPORT. DIAGNOSIS: SOFT TISSUE, ABDOMINAL WALL, HERNIORRHAPHY: DENSE FIBROVASCULAR CONNECTIVE TISSUE AND FIBROADIPOSE TISSUE, WITH SUTURE GRANULOMA (CLINICALLY, RECURRENT VENTRAL HERNIA). TISSUE SOURCE: ABDOMINAL WALL. GROSS DESCRIPTION: \u00bfRECEIVED IN FORMALIN LABELLED \u00bfABDOMINAL WALL\u00bf IS A MOTTLED WHITE PINK TO TAN YELLOW FOCALLY CAUTERIZED RUBBERY TISSUE RANGING FROM 1.8 X 1.6 X 0.6 CM TO 6.5 X 2.0 X 1.2 CM. SEVERAL OF THE TISSUES DISPLAY BLUE SYNTHETIC SUTURE MATERIAL. REPRESENTATIVE SECTIONS ARE SUBMITTED LABELLED 1 AND 2.\u00bf RELEVANT MEDICAL INFORMATION: ON (B)(6) 2000: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: MORBID OBESITY. VERTICAL BANDED GASTROPLASTY. IMPLANT: TRELEX NATURAL MESH. INDICATIONS: \u00bfTHE PATIENT IS A 41 YEAR OLD FEMALE WITH A HISTORY OF MORBID OBESITY WHOSE PAST SURGICAL HISTORY INCLUDED EXPLORATORY LAPAROTOMY AND OPEN CHOLECYSTECTOMY. THE PATIENT'S HISTORY ALSO INCLUDED RECURRENT VENTRAL HERNIAS WHICH HAVE BEEN REPAIRED MULTIPLE TIMES WITH MESH. AS THE PATIENT'S STATUS IS CURRENTLY, SHE HAS A LARGE VENTRAL DEFECT WHICH SHOWS NO SIGNS OF INCARCERATION. IN ADDITION, THE PATIENT HAS A SINGLE DRAINING SINUS PRESUMABLY FROM COLONIZED MESH WHICH STILL REMAINS IN PLACE AND THE PATIENT DRAINS CONSTANT AMOUNTS OF SEROPURULENT MATERIAL FROM A SMALL OPENING IN HER ANTERIOR ABDOMINAL WALL. SHE IS FOLLOWED BY DR. (B)(6) FOR THESE MULTIPLE HERNIAS. AT THIS POINT, THE PATIENT'S WEIGHT / HEIGHT RATIO BMI IS 40 AND DESPITE MULTIPLE ATTEMPTS AT LIFESTYLE CHANGES AND DIETING, THE PATIENT HAS HAD NO LUCK AT WEIGHT LOSS. THE PATIENT UNDERSTANDS THE RISKS OF THE PROCEDURE AND THE FACT THAT THE ENTIRE PROCEDURE MAY NOT BE COMPLETED SECONDARY TO THE SIZE OF HER VENTRAL HERNIA AND POSSIBLE INVOLVEMENT OF SMALL BOWEL. NO ATTEMPT WILL BE MADE AT VENTRAL HERNIA REPAIR OR RESECTION OF ANY MESH.\u00bf FINDINGS: \u00bfTHIS 41 YEAR OLD MORBIDLY OBESE FEMALE WITH A HISTORY OF SEVERAL VENTRAL HERNIA REPAIRS AFTER OPEN CHOLECYSTECTOMY UNDERWENT A VERTICAL BANDED GASTROPLASTY. THE BYPASS PORTION OF THE PROCEDURE COULD NOT BE COMPLETED SECONDARY TO THE ADHERENCE OF HER SMALL BOWEL WITHIN HER ABDOMEN WITH ADHESIONS AND POSSIBLE INVOLVEMENT IN A MASSIVE VENTRAL HERNIA. AS DISCUSSED WITH THE PATIENT PREOPERATIVELY, THE RISK OF REPAIR OF THIS HERNIA WITH INFECTED MESH WAS TOO GREAT TO JUSTIFY CONTINUING THE BYPASS PROCEDURE IN THIS CASE.\u00bf PROCEDURE: \u00bfWITH THE PATIENT LYING SUPINE AND ADEQUATE GENERAL ENDOTRACHEAL ANESTHESIA ADMINISTERED, THE PATIENT'S ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE MASSIVE DEFECT IN THE PATIENT'S VENTRAL HERNIA WAS APPRECIATED PREOPERATIVELY AND A LEFT SUBCOSTAL INCISION WAS MADE MEASURING APPROXIMATELY 15 CM LONG IN THE PATIENT'S LEFT UPPER QUADRANT. THIS WAS CARRIED DOWN TO THE SOFT TISSUE AND THE ANTERIOR AND POSTERIOR SHEATHS OF THE RECTUS MUSCLE AND THE PERITONEAL CAVITY WAS ENTERED WITHOUT INJURY TO UNDERLYING STRUCTURES. IT BECAME QUITE OBVIOUS WITH THE LYSIS OF SEVERAL ADHESIONS THAT THE STOMACH WAS INDEED REACHABLE AND THE GASTRIC PORTION OF THE PROCEDURE COULD BE UNDERTAKEN. HOWEVER, IT WAS NOTED DUE TO MASSIVE ADHESIONS AND BOWEL WITHIN THIS LARGE VENTRAL DEFECT THAT ONLY APPROXIMATELY 70 CM OF SMALL BOWEL COULD BE REACHED AND WORKED ON. AS DISCUSSED WITH THE PATIENT PREOPERATIVELY, THE INTRAOPERATIVE DECISION WAS MADE NOT TO TRY TO REDUCE OR REPAIR ANY OF THIS HERNIA GIVEN THE FACT THAT THERE WAS MESH WITH SOME PORTIONS OF INFECTED MESH PRESENT. FOR THIS REASON, THE INTRAOPERATIVE DECISION TO ONLY DO THE VERTICAL BANDED GASTROPLASTY WITHOUT THE BYPASS WAS MADE. THE STOMACH WAS MOBILIZED ALONG THE LESSER CURVATURE AND ALSO THE GASTROESOPHAGEAL JUNCTION ISOLATED AND SURROUNDED WITH THE PENROSE DRAIN. ALONG THE LESSER CURVATURE OF THE STOMACH, APPROXIMATELY 10 CM FROM THE GASTROESOPHAGEAL JUNCTION, AN EEA STAPLER WAS PASSED THROUGH THE ANTERIOR WALL EXITING THE POSTERIOR WALL OF THE STOMACH AND WAS FIRED CREATING AN APPROXIMATELY 2 CM DIAMETER HOLE DIRECTLY IN THE STOMACH. THE LESSER SAC WAS FREED OF ALL ADHESIONS AND SERIAL GIA STAPLERS WERE USED TO TRANSECT FROM THE POINT OF THIS CIRCULAR OPENING TO THE LATERAL EDGE OF THE GASTROESOPHAGEAL JUNCTION. AN ESOPHAGEAL STENT WAS IN PLACE TO ASSURE AN ADEQUATE POUCH WAS CREATED. THE STAPLE LINES OF THE GIA WERE THEN OVERSEWN WITH INTERRUPTED AND RUNNING SILK SUTURES. A PROLENE MESH BAND WAS THEN CREATED AT THE DISTAL END OF THE POUCH AND SUTURED LOOSELY AROUND THE DISTAL END. THE ABDOMEN WAS THOROUGHLY IRRIGATED. GOOD HEMOSTASIS WAS NOTED. THE ABDOMEN WAS THEN CLOSED IN MULTIPLE LAYERS WITH A LAYER OF RUNNING VICRYL SUTURE IN THE POSTERIOR SHEATH, ANTERIOR SHEATH, SCARPA'S AND INTERRUPTED VICRYL SUTURES IN THE DERMAL LAYER. THE SKIN WAS THEN CLOSED WITH STAPLES AND A DRY, STERILE DRESSING APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS THE EXTUBATED AND STABLE TO THE POST ANESTHESIA CARE UNIT.\u00bf EXPLANT #1 PREOPERATIVE COMPLAINTS: ON (B)(6) 2000: (B)(6), MD. INDICATIONS: \u00bfTHIS PATIENT HAS HAD MULTIPLE VENTRAL HERNIAS IN THE PAST AND SHE IS MASSIVELY OBESE. SHE RECENTLY UNDERWENT A GASTROPLASTY BECAUSE OF HER INABILITY TO LOSE WEIGHT AND THE FACT THAT SHE HAS A RECURRENT HERNIA DUE TO INCREASED OBESITY. POSTOPERATIVELY AFTER THE GASTROPLASTY, SHE DEVELOPED A WOUND INFECTION WHICH WAS OPENED AND DRAINED BY DR. (B)(6) AND SHE ALSO DEVELOPED A FISTULA OF THE MID PORTION OF THE WOUND OF THE PREVIOUS HERNIA WHICH HAD BEEN PRESENT OFF AND ON BEFORE. THE IMPRESSION WAS THAT SHE HAD A SMALL BOWEL FISTULA AND SHE IS NOW ADMITTED BECAUSE OF INCREASED PAIN AND INCREASED DRAINAGE FROM THE MID PORTION OF THE WOUND ON THE MID LINE.\u00bf EXPLANT #1 PROCEDURE: REPAIR OF MASSIVE VENTRAL INCISIONAL HERNIA WITH REPAIR OF SMALL BOWEL FISTULA BY DOING ENTEROENTEROSTOMY AND APPLICATION OF DEXON MESH OVER THE REPAIRED HERNIA. EXPLANT GORE-TEX. EXPLANT #1 DATE: ON (B)(6) 2000 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 2000: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: LARGE VENTRAL INCISIONAL HERNIA AND SMALL BOWEL FISTULA. ANESTHESIA: GENERAL. PROCEDURE: \u00bfUNDER SATISFACTORY GENERAL ENDOTRACHEAL ANESTHESIA AND WITH THE PATIENT IN THE SUPINE POSITION, THE SKIN OF THE ENTIRE ABDOMEN WAS PREPPED WITH BETADINE SCRUB AND SOLUTION. STERILE DRAPES WERE THEN APPLIED AND AN INCISION WAS THEN MADE AROUND THE OLD SURGICAL SCAR AND ON THAT INCLUDED THE PART WHERE THERE WAS A FISTULA ON THE MID PORTION OF THE MID LINE UPPER ABDOMEN AND AROUND THE UMBILICUS. THE INCISION WAS THEN DEEPENED THROUGH SKIN AND SUBCUTANEOUS TISSUE. IT WAS EVIDENT THAT THE PATIENT HAD A BIG COLLECTION OF FLUID ON THE LEFT SIDE OF THE OLD SCAR WHICH WAS CONSISTENT WITH SMALL BOWEL CONTENTS AND A SPECIMEN OF THAT WAS TAKEN FOR CULTURE AND SENSITIVITY. WE THEN PROCEEDED BY RESECTING THE ENTIRE SCAR AND SENDING IT OUT TO PATHOLOGY. THE PATIENT HAD A VERY LARGE VENTRAL INCISIONAL HERNIA WHICH CONTAINED THE OLD PROLENE MESH, AS WELL AS A GORE-TEX MESH AND ALL THE OLD MESH OF PROLENE, AS WELL AS THE GORE-TEX MESH WAS REMOVED AND SENT TO PATHOLOGY. ASSOCIATED WITH THIS SCAR WERE THE BORDERS OF THE FASCIA WHICH ALSO CONTAINED SMALL SEGMENT OF THE SMALL BOWEL WHICH WAS DEEPLY ADHERENT TO THE SCAR WITH THE SMALL BOWEL FISTULA. I HAD TO RESECT A PART OF THE SMALL BOWEL WHICH WAS THE CAUSE OF HER SMALL BOWEL FISTULA. WITH THIS DONE, THEN THE BORDERS OF THE FASCIA WERE REFRESHED AND UNTIL COMPLETELY NORMAL TISSUE AND ALL THE SCAR TISSUE, AS WELL AS THE MESH HAD BEEN REMOVED AND SENT TO PATHOLOGY. WITH THIS DONE, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED WITH SALINE AND DRIED AND EXAMINATION OF THE ENTIRE CAVITY REVEALED TO BE NORMAL. I COULD NOT FIND ANY DEFINITE STONES IN THE GALLBLADDER. THERE WERE ADHESIONS IN THE LEFT UPPER QUADRANT FROM THE PREVIOUS GASTROPLASTY AND I DID NOT ENTER IN THAT AREA. THERE WAS NO EVIDENCE OF INTRAABDOMINAL ABSCESS AND THE ENTIRE SMALL BOWEL WAS RUN FROM THE LIGAMENT OF TREITZ ALL THE WAY DOWN TO THE ILEOCECAL VALVE REVEALING ONLY THIS DEFECT OF THE SMALL BOWEL WHICH WAS THE AREA WHICH WAS CAUSING THE SMALL BOWEL FISTULA. AT THIS STAGE, I DECIDED TO REPAIR THIS SMALL BOWEL FISTULA BY BRINGING THE TWO LOOPS OF THE PROXIMAL DISTAL END OF THE BOWEL AROUND THE AREA OF THE DEFECT ON THE ANTERIOR WALL OF THE BOWEL AND I DID INSERT A GIA THROUGH THESE TWO OPENINGS IN THE PROXIMAL AND DISTAL ENDS OF THE BOWEL AND SIDE-TO-SIDE (PROXIMAL END) FUNCTIONAL END-TO-END ANASTOMOSIS WAS THEN CARRIED OUT. THE GIA STAPLER WAS APPLIED AND FIRED AND THE OPENING OF THE BOWEL WAS THEN CLOSED USING TA-55 ACHIEVING EXCELLENT LUMEN OF THE BOWEL AND WITH A GOOD BLOOD SUPPLY AND NO EVIDENCE OF ANY TENSION. WITH THIS DONE, THE ABDOMINAL CAVITY WAS THOROUGHLY IRRIGATED WITH SALINE AND DRIED AND TO HAVE A COMPLETELY CLEAN RETURN. THE FASCIAL DEFECT MEASURED ABOUT 15 X 10 CM. AT THIS STAGE I FELT THAT SINCE THERE WAS A SMALL BOWEL FISTULA THAT I WOULD NOT USE NONABSORBABLE MESH TO CLOSE THE FASCIAL DEFECT BECAUSE I WAS AFRAID THAT THIS WOULD BE CONTAMINATED WITH THE SMALL BOWEL CONTENTS AND IT COULD CAUSE PERSISTENT INFECTION ON THE WOUND AND ALSO COULD IN THE FUTURE CAUSE RECURRENT HERNIA DUE TO INFECTION. SO I FELT THAT AT BEST, EVEN THOUGH THERE WOULD BE SOME SMALL AMOUNT OF TENSION ON THE WOUND, WAS TO CLOSE THE WOUND IN ONE LAYER USING A RUNNING SUTURE OF #2 ETHILON BRINGING THE ANTERIOR AND POSTERIOR FASCIA, AS WELL AS PERITONEUM. THIS WAS DONE IN SHORT RUNS OF CONTINUOUS SUTURE WITH #2 NYLON AND ACHIEVING, ALTHOUGH THERE WAS A LITTLE BIT OF TENSION, A GOOD CLOSURE OF THE FASCIA DEFECT AND THE ENTIRE WOUND. I HAVE TO ADD THAT THERE WERE MULTIPLE OTHER DEFECTS ON THE MIDLINE ON THE UPPER PART OF THE INCISION. I WAS PRETTY SATISFIED WITH THE CLOSURE AND ON TOP OF THAT THEN I DID PUT A PIECE OF DEXON MESH REINFORCING THIS WHICH IS AN ABSORBABLE MESH AND THIS WAS THEN SUTURED OVER THE FASCIA USING A RUNNING SUTURE OF #2-0 PROLENE ACHIEVING A GOOD REINFORCEMENT OF THE FASCIAL CLOSURE. THE SUBCUTANEOUS WAS THEN CLOSED WITH INTERRUPTED SUTURES OF #3-0 DEXON. THE SKIN WAS CLOSED WITH SURGICAL STAPLES. I DID PUT A JACKSON-PRATT DRAIN IN THE WOUND AND BROUGHT IT OUT THROUGH A SEPARATE STAB WOUND IN THE LOWER PART OF THE ABDOMEN. THIS JACKSON-PRATT DRAIN WAS SUTURED IN PLACE WITH A #4-0 NYLON. A COMPRESSIVE DRY, STERILE DRESSING WAS APPLIED. THE PATIENT TOLERATED THE PROCEDURE WELL. I HAVE TO ADD THAT THERE WERE NO OTHER ABNORMALITIES IN THE SMALL BOWEL BESIDES THE ONE IN THE AREA THAT WAS CAUSING THE FISTULA AND THE ENTIRE LARGE BOWEL WAS INSPECTED FROM THE CECUM ALL THE WAY DOWN TO THE RECTOSIGMOID AND THAT DID NOT SHOW EVIDENCE OF A MASS AND NO EVIDENCE OF DIVERTICULITIS, BUT A FEW DIVERTICULA AND PALPATION OF THE UTERUS AND THE OVARIES DID NOT REVEAL ANY EVIDENCE OF A MASS. THEY WERE OF NORMAL SIZE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.\u00bf ON (B)(6) 2000: (B)(6), MD. PATHOLOGY REPORT. TISSUE SOURCE: HERNIA SAC SEGMENT OF SMALL BOWEL. DIAGNOSIS: LABELED \u00bfHERNIA SAC AND SEGMENT OF SMALL BOWEL\u00bf. HEMORRHAGIC MUCOSAL NECROSIS, SMALL INTESTINE WITH ADHESION TO FASCIA AND SKIN AT SITE OF HERNIA REPAIR. NOTE: SEGMENT OF SMALL BOWEL APPEARS TO BE ADHERENT TO FASCIA AS WELL AS FIBROADIPOSE TISSUE AND SKIN AT THE SITE OF MESH PLACEMENT AND DERMAL SCAR. APPEARANCES ARE CONSISTENT WITH AN ENTEROCUTANEOUS FISTULA, STATUS POST PREVIOUS REPAIR OF ABDOMINAL HERNIA. GROSS DESCRIPTION: LABELLED \"HERNIA SAC, SEGMENT OF SMALL BOWEL\". \u00bfRECEIVED IN FORMALIN IS AN 18.0 X 4.0 CM ELLIPSE OF TAN HAIRLESS SKIN WITH TWO STELLATE SHAPED RETRACTED SCARS MEASURING 2.0 CM EACH. THE SKIN ELLIPSE IS ATTACHED TO A 25.0 X 19.0 CM FIBROUS AND MEMBRANOUS TISSUE RANGING IN THICKNESS FROM 1.3 X 0.3 CM. MULTIPLE ATTACHED UNREMARKABLE FATTY LOBULES ARE ALSO IDENTIFIED. THE FIBROMEMBRANOUS TISSUE IS INTERMIXED WITH A MESH WITH MULTIPLE SURGICAL STITCHES EMBEDDED INTO DENSE FIBROUS TISSUE. SIX ADDITIONAL PIECES OF FIBROUS TISSUE WITH SURGICAL STITCHES INTERMIXED WITH PIECES OF MESH ARE ALSO RECEIVED, AVERAGING IN SIZE FROM 4.0 X 2.5 X 0.4 CM, TO 13.0 X 4.5 X 0.5 CM. A 1.1 CM LONG X 2.6 CM IN DIAMETER DONUT SHAPED SEGMENT OF BOWEL IS ALSO IDENTIFIED. THE MUCOSAL SURFACE IS TAN AND EDEMATOUS WITHOUT DISTINCT LESIONS. THE WALL MEASURES 0.3 CM AND REVEALS AN UNREMARKABLE MUSCULARIS PROPRIA WITH SURROUNDING HEMORRHAGIC SOFT TISSUES. REPRESENTATIVE SECTIONS ARE SUBMITTED AS FOLLOWS: 1 - SEGMENT OF BOWEL, TWO PIECES. 2 - SKIN WITH SCAR, ONE SECTION. 3 - FIBROMEMBRANOUS TISSUE, TWO PIECES. 4 - FIBROMEMBRANOUS TISSUE, TWO PIECES.\u00bf IMPLANT #2, #3, #4 PREOPERATIVE COMPLAINTS: NO INFORMATION. IMPLANT #2, #3, #4 PROCEDURE: LAPAROSCOPIC LYSIS OF ADHESIONS AND INCISIONAL HERNIA REPAIR WITH GORE-TEX MESH. IMPLANT: GORE\u00ae DUALMESH\u00ae BIOMATERIAL X 3 [1DLMC07 / 00668394, 20X30CM; 1DLMC07 / 00604719, 20X30CM; 1DLMC03 / 00670141, 10X15CM]. IMPLANT #2, #3, #4 DATE: ON (B)(6) 2001 (HOSPITALIZATION DATES UNKNOWN). ON (B)(6) 2001: [DICTATION DATE: ON (B)(6) 2001]: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE DIAGNOSIS: RECURRENT INCISIONAL HERNIA. POSTOPERATIVE DIAGNOSIS: MULTIPLE RECURRENT INCISIONAL HERNIAS. ANESTHESIA: GENERAL. PROCEDURE: \u00bfTHE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION AND AFTER THE ADMINISTRATION OF GENERAL ENDOTRACHEAL ANESTHESIA, THE ABDOMEN WAS PREPPED AND DRAPED IN STERILE FASHION. A STERI-DRAPE WAS USED FOR THIS AND THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS. VENODYNE BOOTS WERE PLACED AND A FOLEY CATHETER AND AN OROGASTRIC TUBE WERE INSERTED. THE PERITONEAL CAVITY WAS ACCESSED USING AN OPEN TECHNIQUE. THE ABDOMEN WAS INSUFFLATED TO 12 MMHG WITH C02. ADDITIONAL WORKING PORTS WERE PLACED AND THERE WAS NOTED TO BE NUMEROUS, DENSE ADHESIONS BETWEEN THE LIVER AND THE ABDOMINAL WALL, AS WELL AS BETWEEN THE BOWEL AND OMENTUM AND ABDOMINAL WALL. THIS WAS A PAINSTAKING LYSIS OF ADHESIONS. IT TOOK A CONSIDERABLE AMOUNT OF TIME AND WAS VERY DIFFICULT. DESPITE THIS, THIS WAS SAFELY PERFORMED WITH METICULOUS SURGICAL TECHNIQUE. WE USED MINIMAL CAUTERY FOR THIS PORTION OF THE OPERATION. ONCE WE EXPOSED THE ABDOMINAL WALL, THERE WAS A 2 X 2 CM PERIUMBILICAL DEFECT AND A 17 X 17 CM DEFECT JUST TO THE LEFT OF THE MIDLINE AT THE COSTAL MARGIN. IN ORDER TO COMPLETELY COVER THE DEFECT, AS WELL AS THE ENTIRE MIDLINE INCISION, WE PLACED A 20 X 30 MESH TRANSVERSELY UP UNDER THE LEFT COSTAL MARGIN AND A 20 X 30 MESH PLACED LONGITUDINALLY TO COVER THE PERIUMBILICAL DEFECT IN THE ENTIRE OLD INCISION. THE LEFT LOWER PORTION OF THE 17 X 17 CM DEFECT WAS CLOSE SO WE ADDED AN ADDITIONAL 10 X 15 CM PATCH TO SECURE THIS CORNER. THE COMBINATION OF MESHES WERE SECURED WITH 11 FULL THICKNESS CV2 GORE-TEX SUTURES AND TACKS AROUND THE PERIPHERY. THE MESH EXTENDED UP TO THE XIPHOID PROCESS AND CLEARLY ABOVE THE LEFT COSTAL MARGIN GIVING US ADEQUATE OVERLAP AROUND ALL ASPECTS OF THE DEFECTS AND COVERING COMPLETELY THE OLD INCISIONS. THE PORTS WERE ALL REMOVED AND THE C02 WAS ALLOWED TO ESCAPE. THE SKIN WAS CLOSED IN A STANDARD FASHION WITH SUBCUTICULAR MONOCRYL AND STERI-STRIPS. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. ESTIMATED BLOOD LOSS WAS MINIMAL. SHE WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION.\u00bf ON (B)(6) 2001: (B)(6) CENTER. IMPLANT STICKERS. 1. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC07. LOT#: 00668394. 2. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC07. LOT#: 00604719. 3. \u00bfGORE-TEX DUALMESH BIOMATERIAL.\u00bf ITEM#: 1DLMC03. LOT#: 00670141. RELEVANT MEDICAL INFORMATION: ON (B)(6) 2002: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: PERIRECTAL AND ISCHIORECTAL ABSCESS. INFECTED SEBACEOUS CYST OF THE FACE. PROCEDURE: INCISION AND DRAINAGE OF ISCHIORECTAL ABSCESS. EXCISION OF INFECTED SEBACEOUS CYST OF THE FACE, 1-2 CM. RIGID SIGMOIDOSCOPY. FINDINGS: \u00bfTHE PATIENT HAD AN EXTENSIVE ABSCESS THAT EXTENDED ALONG THE LEFT SIDE OF THE RECTUM AND UNDER THE LEVATORS. IT WENT AROUND THE MIDLINE POSTERIORLY, AND ANTERIORLY IT WENT TO THE COOPER'S LIGAMENT AND PUBIS. LATERALLY IT EXTENDED INTO THE GLUTEUS. IT HAD VERY FOUL SMELLING ODOR. SURPRISINGLY, THE TISSUES OF THE CAVITY DID NOT SHOW ANY NECROSIS. RIGID SIGMOIDOSCOPY UP TO 20 CM DID NOT SHOW ANY OBVIOUS CANCER. I DID SEE SOME DIVERTICULA, BUT I DID NOT SEE ANY INFLAMMATION.\u00bf ON (B)(6) 2002: (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: EXTENSIVE PERIRECTAL ABSCESS. PROCEDURE: DRESSING CHANGES UNDER ANESTHESIA. FINDINGS: \u00bfTHERE WAS STILL PURULENT FLUID DEEP IN THE CAVITY OF THE ABSCESS, ONE EXTENDING BELOW THE LEVATORS AND AROUND THE AREA OF THE COOPER'S LIGAMENT AND PUBIS. THE TISSUES WERE ACTUALLY FAIRLY VIABLE EXCEPT FOR THE MOST SUPERFICIAL PART THAT SHOWED SOME SUPERFICIAL BLACK NECROSIS OF THE CONNECTIVE TISSUE. THERE WAS NO OBVIOUS FISTULA CONNECTING WITH THE RECTUM.\u00bf ON (B)(6) 2011: (B)(6), MD. OPERATIVE REPORT. ASSISTANT: (B)(6), MD. PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS: INFRARENAL ABDOMINAL AORTIC ANEURYSM. PROCEDURE: ENDOVASCULAR ANEURYSM REPAIR WITH GORE EXCLUDER C3 GRAFT. CUT-DOWNS WERE PERFORMED ON BOTH GROINS. ON (B)(6) 2011: (B)(6), MD. IMPLANT RECORD. EXCLUDER. IMPLANT SITE: AORTA. EXCLUDER. IMPLANT SITE: RIGHT COMMON ILIAC ARTERY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3750 W. KILTIE LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86004", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/11/2020;09/11/2020;04/01/2021;03/13/2023" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "ELKTON", "manufacturer_contact_address_1": "1505 N. FOURTH STREET", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "3003910212-2020-01069", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200903", "manufacturer_address_2": "", "pma_pmn_number": "K033671", "date_of_event": "20190506", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "86004", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "REIGH", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "219221408", "manufacturer_g1_state": "MD", "reporter_country_code": "US", "manufacturer_contact_area_code": "928", "date_added": "20200903", "manufacturer_contact_f_name": "MEGAN", "device_date_of_manufacturer": "20131216", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200903", "brand_name": "GORE\u00ae BIO-A\u00ae HERNIA PLUG", "generic_name": "MESH, SURGICAL, ABSORBABLE, ABDOMINAL HERNIA", "manufacturer_d_name": "W. L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "1505 N. FOURTH STREET", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86004", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86004", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20161031", "model_number": "HP01", "catalog_number": "HP01", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OWT", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00733132606146", "udi_public": "(01)00733132606146(17)161", "openfda": { "registration_number": [ "3003910212" ], "fei_number": [ "3003910212" ], "device_name": "Mesh, Surgical, Absorbable, Abdominal Hernia", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3300", "device_class": "2" } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/14/2020;02/05/2021;02/05/2021", "manufacturer_contact_country": "US", "date_changed": "20240208", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "1408", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200903", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "68 YR", "patient_sex": "Male", "patient_weight": "83 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Unspecified Infection", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230309", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "10489219", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200814", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "21922", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MPD APC B/P", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "323721545", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED RESULTS CODE. CONCLUSION CODE REMAINS UNCHANGED. IT SHOULD BE NOTED THAT THE GORE\u00ae BIOABSORBABLE HERNIA PLUG INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" \u00a0 THE GORE\u00ae BIOABSORBABLE HERNIA PLUG INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "334850350", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: UPDATED INVESTIGATION CONCLUSIONS: D17: APPROPRIATE CODE/TERM NOT AVAILABLE FOR \u00bfFALSE CLAIM\u00bf AND \u00bfWITHDRAWN COMPLAINT\u00bf. THIS CLAIM WAS WITHDRAWN, AND THE ALLEGED PRODUCT COMPLAINT IS NO LONGER BEING PURSUED AT THIS TIME. THE INVESTIGATION HAS BEEN COMPLETED. BASED UPON THE TOTALITY OF THE INFORMATION RECEIVED OVER THE COURSE OF THE INVESTIGATION AND REPORTED BY GORE IN THE PREVIOUSLY SUBMITTED MEDICAL RECORD NARRATIVES THE FOLLOWING CONCLUSIONS HAVE BEEN REACHED. AS PREVIOUSLY REPORTED, ALL PERTINENT MEDICAL RECORDS REQUESTED MAY NOT HAVE BEEN RECEIVED. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. BASED UPON GORE\u00bfS INVESTIGATION THERE IS NO AVAILABLE INFORMATION THAT REASONABLY SUGGESTS THAT A GORE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO DEATH, SERIOUS INJURY OR REPORTABLE MALFUNCTION, AND IS NO LONGER CONSIDERED REPORTABLE. THEREFORE, THIS EVENT IS BEING CODED AS NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, NO HEALTH CONSEQUENCES OR IMPACT AND WILL BE CLOSED AS FALSE CLAIM, NO PROBLEM DETECTED, AND \u00bfWITHDRAWN.\u00bf PREVIOUS PATIENT CODES WERE REPORTED BASED ON THE ORIGINAL COMPLAINT AND ARE NO LONGER APPLICABLE AND/OR NOT REPORTABLE PER GORE\u00bfS INVESTIGATION. IT SHOULD BE NOTED THAT THE GORE\u00ae BIO-A\u00ae HERNIA PLUG INSTRUCTIONS FOR USE STATES, \u00bfAS PACKAGED, THE GORE\u00ae BIO-A\u00ae HERNIA PLUG IS A TAILORABLE, BIOABSORBABLE MATERIAL INTENDED TO BE A TEMPORARY BRIDGE OF DEFECTS UNTIL THE BIOABSORBABLE NATURE OF THE DEVICE ALLOWS THE BODY TO FILL THE DEFECT WITH NATIVE TISSUE. THE DEVICE IS COMPRISED OF A DISK ATTACHED TO MULTIPLE TUBES. THE IMPLANTED GORE\u00ae BIO-A\u00ae HERNIA PLUG IS A POROUS FIBROUS STRUCTURE COMPOSED SOLELY OF SYNTHETIC BIOABSORBABLE POLY (GLYCOLIDE: TRIMETHYLENE CARBONATE) COPOLYMER. DEGRADED VIA A COMBINATION OF HYDROLYTIC AND ENZYMATIC PATHWAYS, THE COPOLYMER HAS BEEN FOUND TO BE BOTH BIOCOMPATIBLE AND NONANTIGENIC. IN VIVO STUDIES WITH THIS COPOLYMER INDICATE THE BIOABSORPTION PROCESS SHOULD BE COMPLETE BY SIX TO SEVEN MONTHS.\u00bf THEREFORE, THIS GORE DEVICE WOULD NOT BE EXPECTED TO CONTRIBUTE TO EXPLANT, ADHESIONS, GASTROINTESTINAL FISTULA, INFECTION, LACK OF/INADEQUATE DEVICE TISSUE INCORPORATION OR INGROWTH, EROSION/EXTRUSION, AND AN ADDITIONAL SURGICAL PROCEDURE BEYOND THIS TIMEFRAME. THE GORE\u00ae BIO-A\u00ae HERNIA PLUG INSTRUCTIONS FOR USE INCLUDE WARNINGS AND ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS MAY INCLUDE, BUT ARE NOT LIMITED TO, INFECTION, INFLAMMATION, ADHESIONS AND SEROMA FORMATION. THE INSTRUCTIONS FOR USE FURTHER WARN: \u00bfAS WITH ANY IMPLANTABLE SURGICAL DEVICE, STRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\u00bf PROCEDURE AND SPECIFIC PATIENT FACTORS MAY CONTRIBUTE TO OR CAUSE INFECTION, LEADING TO CONTAMINATION, EXPOSURE, LACK OF INCORPORATION AND/OR SEEDING OF DEVICE. PROCEDURE RELATED FACTORS MAY INCLUDE ADHERENCE TO CLINICAL GUIDELINES ON INFECTION RISK MANAGEMENT, CONTAMINATION OF DEVICE PRIOR TO OR DURING IMPLANT, AND POST-OPERATIVE PERSISTENT/SYMPTOMATIC SEROMA AND WOUND MANAGEMENT. PATIENT RISK FACTORS MAY INCLUDE DIABETES, SMOKING, AGE, MALNUTRITION, IMMUNOSUPPRESSIVE THERAPY, POST-OPERATIVE INSTRUCTION NONCOMPLIANCE, AND HYGIENE. AS WITH ANY SURGICAL PROCEDURE, THERE ARE ALWAYS RISKS OF COMPLICATIONS FOR SURGICAL REPAIR OF HERNIAS AND SOFT TISSUE DEFICIENCIES, WITH OR WITHOUT BIO-A. THESE MAY INCLUDE BUT ARE NOT LIMITED TO, ADHESIONS AND RELATED HARMS, BLEEDING, BOWEL OBSTRUCTION, COMPROMISED DEVICE BIOCOMPATIBILITY, CONTAMINATION WHICH MAY LEAD TO PATIENT HARMS, DEVICE DAMAGE, DYSPHAGIA, EROSION OR EXTRUSION AND RELATED HARMS, EXPOSURE OR PROTRUSION AND RELATED HARMS, FEVER, FISTULA, GERD RECURRENCE, DEFECT RECURRENCE AND RELATED HARMS, ILEUS, INCREASED PROCEDURE TIME AND RELATED HARMS, IRRITATION OR INFLAMMATION, INFECTION, MIGRATION, CONTRACTION, PAIN, PARESTHESIA, PERFORATION, REVISION / RE-INTERVENTION, SEROMA OR HEMATOMA AND RELATED HARMS, TISSUE ISCHEMIA, WOUND COMPLICATIONS AND WOUND DEHISCENCE AND ADDITIONAL INTERVENTION INCLUDING SURGERY. MANY OF THE POTENTIAL COMPLICATIONS ARE ASSOCIATED WITH THE PATIENT\u00bfS UNDERLYING DISEASE PROGRESSION, CO-MORBIDITIES, ADDITIONAL MEDICAL HISTORY AND/OR OTHER SURGICAL PROCEDURES. THE ABOVE INHERENT RISKS ARE TYPICALLY DETAILED IN STANDARD INFORMED CONSENT DOCUMENTS. BASED UPON THE INFORMATION RECEIVED, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. W.L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \"DEFECTS\" OR HAS \"MALFUNCTIONED\". THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT." }, { "mdr_text_key": "321774792", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B7: ADDED MEDICAL HISTORY. H6: CONCLUSION CODE REMAINS UNCHANGED. H10/11: ADDED MEDICAL RECORD INFORMATION. ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WERE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: RELEVANT MEDICAL INFORMATION: (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), MD. ANESTHESIA RECORD. SURGERY PLANNED: LAP COLECTOMY. PROBLEM LIST: CROHN\u00bfS DISEASE, HYPERTENSION, KIDNEY REPLACED BY TRANSPLANT. ASA CLASS: 3. WEIGHT 184.36 POUNDS, BMI 24.4. (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), MD; (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSIS: COLONIC STRICTURE, STATUS POST CROHN DISEASE. POSTOPERATIVE DIAGNOSIS: COLONIC STRICTURE, STATUS POST CROHN DISEASE. PROCEDURE: 1) CYSTOURETHROSCOPY. 2) BILATERAL URETERAL STENT PLACEMENT. 3) GRAFTED RIGHT ILIAC FOCI, RENAL TRANSPLANT STENT PLACEMENT. 4) RETROGRADE PYELOGRAM X3. 5) INTERPRETATION OF FLUOROSCOPIC IMAGES IN LESS THAN 1 HOUR. THE COLORECTAL SERVICE WILL DICTATE THEIR PROCEDURE SEPARATELY. (B)(6) 2013: (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. FIRST ASSISTANT: (B)(6), MD. PREOPERATIVE DIAGNOSES: 1) KIDNEY FAILURE STATUS POST KIDNEY TRANSPLANT. 2) CROHN DISEASE WITH DESCENDING COLON STRICTURE. POSTOPERATIVE DIAGNOSES: 1) KIDNEY FAILURE STATUS POST KIDNEY TRANSPLANT. 2) CROHN DISEASE WITH DESCENDING COLON STRICTURE. PROCEDURE: LAPAROSCOPIC HAND-ASSISTED LEFT HEMICOLECTOMY, FLEXIBLE SIGMOIDOSCOPY, DIVERTING LOOP ILEOSTOMY. CYSTOSCOPY AND STENTS BY UROLOGY. INDICATIONS FOR PROCEDURE: PATIENT IS A 63 YEARS OLD WITH HISTORY OF KIDNEY TRANSPLANT OVER 10 YEARS AGO, ALSO DIAGNOSED WITH CROHN DISEASE, HAVING A CROHN STRICTURE IN HIS LEFT COLON. HE IS THUS BROUGHT TO THE OPERATING ROOM FOR RESECTION OF THIS. DESCRIPTION OF PROCEDURE: \u00bfHE IS PREPPED AND DRAPED IN THE STANDARD SURGICAL FASHION. HE RECEIVED ANCEF AND FLAGYL FOR PROPHYLAXIS. HE IS IN LOW LITHOTOMY POSITION. ACCESS TO HIS ABDOMEN IS OBTAINED USING A SUPRAUMBILICAL INCISION, ALTHOUGH WE LATER NOTE THAT HE HAS AN INFRAUMBILICAL HERNIA. WE ALSO PLACE A RIGHT LOWER QUADRANT 10 MM PORT TAKING CARE NOT TO GET IN THE WAY OF THE TRANSPLANTED KIDNEY. THE 5 MM PORT IS THEN PLACED IN THE RIGHT UPPER QUADRANT, AS WELL AS AN ADDITIONAL 5 MM PORT IN THE LEFT LOWER QUADRANT. ATTENTION IS TURNED TO THE SIGMOID COLON WHERE WE BEGAN DISSECTING AT THE BASE OF THE MESENTERY TO THE SACRAL PROMONTORY. THE SAME THING IS DONE ON THE RIGHT AND THE LEFT. THIS IS FOLLOWED UP, AS SOON WE SEE THIS ABNORMAL AREA OF COLONIC STRICTURE. AT THIS POINT, WE CHANGE TO A HAND-ASSISTED TECHNIQUE. AN INFRAUMBILICAL INCISION IS MADE AND GELPORT IS PLACED IN ORDER TO MOBILIZE THIS AREA WHICH APPEARS TO BE ROCK HARD. IT IS COMPLETELY PLASTERED TO THE RETROPERITONEUM, AND THERE IS 1 AREA THAT APPEARS TO HAVE ALMOST PERFORATED FISTULA INTO THE RETROPERITONEUM. WE CONTINUE DISSECTION ALL THE WAY UP TO THE SPLENIC FLEXURE. THIS ENTIRE AREA APPEARS QUITE ABNORMAL. WE THEN TURN OUR ATTENTION TO THE TRANSVERSE COLON WHERE WE DISSECT THE OMENTUM OFF OF THE TRANSVERSE COLON, ALL THE WAY FROM ABOUT MID TRANSVERSE TO THE SPLENIC FLEXURE. WE THEN TURN OUR ATTENTION TO THE SIGMOID COLON. WE BEGAN TAKING THE MESENTERY MEDIALLY AND ALLOWING THE ENTIRE COLON MEDIALIZE. WE THEN TRANSECT AROUND THE SPLENIC FLEXURE, AS WELL AS AT THE PROXIMAL AREA OF THE STRICTURE. THE ENTIRE STRICTURE LENGTH IS APPROXIMATELY A FOOT LONG. WE USE THE 5 MM LIGASURE TO THROUGH THE MESENTERY, AND A VASCULAR LOAD OF THE STAPLER TO GO THROUGH THE VESSELS. WHEN IT WAS COMPLETED WE PASS OFF THE SPECIMEN TO BE SENT TO PATHOLOGY. I PERFORMED A FLEXIBLE SIGMOIDOSCOPY TO ASSURE THAT THERE IS NO STRICTURE OR ABNORMAL AREA LEFT. WE THEN DECIDED THAT BECAUSE OF THE AREA THAT HAS THE UMBILICAL HERNIA, WE CONNECT THE UMBILICAL PORT SITE TO OUR PREVIOUS HAND PORT SITE IN ORDER TO REPAIR THE INFRAUMBILICAL HERNIA. ONCE THIS IS DONE, WE CAN SEE THE PROXIMAL END OF THE DESCENDING COLON. WE PASS THE EEA 29 STAPLER THROUGH HIS RECTUM, AND THERE IS NO TENSION ON THIS ANASTOMOSIS. WE CREATE AN END-TO-SIDE ANASTOMOSIS WITH A FIRE OF THE EEA. THE PROXIMAL PART OF THE COLON IS THEN OCCLUDED, AND I GO BELOW TO PERFORM A FLEXIBLE SIGMOIDOSCOPY AND ANASTOMOTIC LEAK TEST. THIS IS NEGATIVE, AND THE DONUTS ARE COMPLETE ON INSPECTION. I THEN RESCRUB, ABOVE AND BECAUSE OF HIS IMMUNOSUPPRESSION BOTH FOR THE TRANSPLANT AS WELL AS ANTI-TNF FOR HIS CROHN\u00bfS, AND THE DIFFICULT DISSECTION, AND THE AMOUNT OF MESENTERY THAT I HAD TO TAKE IN ORDER TO REACH DOWN TO WHERE WE COULD PERFORM ANASTOMOSIS, I DECIDED TO DIVERT HIM PROXIMALLY. WE MEASURE APPROXIMATELY 40 CM PROXIMAL, AND THEN MAKE A SKIN DEFECT AT THE PREVIOUSLY MARKED SITE, USE A MUSCLE-SPARING TECHNIQUE, AND BRING UP A DIVERTING LOOP ILEOSTOMY. WE DO PLACE A 19-FRENCH ROUND FLUTED DRAIN IN THE PELVIS. THE MIDLINE IS CLOSED USING A RUNNING LOOPED PDS WITH INTERRUPTED VICRYL SUTURES. THE SKIN IS LOOSELY APPROXIMATED USING SKIN STAPLES. THE PORT SITES ARE CLOSED WITH A SUTURE PASSER, AND THEN THE SKIN EDGES REAPPROXIMATED USING MONOCRYL AND DERMABOND. STERILE DRESSINGS ARE APPLIED. THE ILEOSTOMY IS THEN MATURED USING 3-0 CHROMIC SUTURE AND ILEOSTOMY APPLIANCE IS PLACED. THE PATIENT IS TURNED TO THE SUPINE POSITION, EXTUBATE AND THEN TRANSPORTED TO PACU IN STABLE CONDITION. HE TOLERATED THE PROCEDURE WELL, AND ALL COUNTS WERE CORRECT. HE GOT 3 L OF CRYSTALLOID, 1.5 OF ALBUMIN. URINE OUTPUT WAS 400, AND EBL WAS 150.\u00bf (B)(6) 2013: EMO(B)(6) HOSPITAL. (B)(6), MD. PATHOLOGY. ACC #: (B)(4). FINAL PATHOLOGIC DIAGNOSIS: A) COLON, ANASTOMOTIC DONUTS, EXCISION: RINGS OF UNREMARKABLE COLON. NEGATIVE FOR MALIGNANCY. B) COLON LEFT, HEMICOLECTOMY: SEGMENT OF STRICTURED BOWEL WITH PATCHY ULCERS AND CHRONIC TRANSMURAL INFLAMMATION. MUCOSA AWAY FROM ULCERS SHOWS ONLY MINIMAL EVIDENCE OF CHRONIC INJURY (PANETH CELL METAPLASIA); THERE IS NO EVIDENCE OF \u00bfTYPICAL\u00bf CHRONIC ACTIVE COLITIS (SEE COMMENT). ONE BENIGN LYMPH NODE (0/1). COMMENT: PART B. THIS PATIENT HAS A HISTORY OF CROHN\u00bfS DISEASE. THE PATHOLOGIC FINDINGS OF WALL THICKENING AND BROAD MUCOSAL ULCERS WITH NEARLY NORMAL INTERVENING MUCOSA COULD BE SEEN IN CROHN\u00bfS DISEASE. HOWEVER, OTHER ETIOLOGIES SUCH AS DRUG-INDUCED INJURY (IE FROM NSAIDS) ARE POSSIBLE. NO DIVERTICULA ARE NOTED, NOR ARE GRANULOMAS OR \u00bfCLASSIC\u00bf HISTOLOGIC FEATURES OF CHRONIC ACTIVE COLITIS. ASSISTED BY: ANTHONY MARTINEZ, MD, RESIDENT. CLINICAL HISTORY: LAP ASSISTED PARTIAL COLECTOMY, FLEXIBLE SIGMOIDOSCOPY, CYSTO WITH URETERAL STENT PLACEMENT. COLONIC STRICTURE. SPECIMEN(S) RECEIVED: A) ANASTOMOTIC DONUTS. B) LEFT COLON. (B)(6) 2013: (B)(6) HOSPITAL. (B)(6). RADIOLOGY-XR ABDOMEN 1 VIEW (KUB). INDICATION: NAUSEA WITH VOMITING; STATUS POST AN ASSISTED LOW ANTERIOR RESECTION WITH DIVERTING LOOP ILEOSTOMY (FOR CROHN\u00bfS WITH A STRICTURE); REMOTE RENAL TRANSPLANT. IMPRESSION: 1) ILEUS VERSUS EARLY SMALL BOWEL OBSTRUCTION. SERIAL FILM VERSUS CT FOR FURTHER EVALUATION. 2) PRESUMED PARTIAL STAGHORN CALCULUS ON THE LEFT. IMPLANT PREOPERATIVE COMPLAINTS: (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), NP. ANESTHESIA RECORD. SURGERY PLANNED: LAPAROSCOPIC ASSISTED COLECTOMY; CYSTOSCOPY AND STENTS, FLEXIBLE SIGMOIDOSCOPY. HISTORY OF PRESENT ILLNESS: HISTORY OF CROHN\u00bfS DISEASE AND A COLONIC STRICTURE WHO PRESENTS FOR LAPAROSCOPIC ASSISTED COLECTOMY; CYSTOSCOPY AND STENTS, FLEXIBLE SIGMOIDOSCOPY. PAST MEDICAL HISTORY AND REVIEW OF SYSTEMS: HYPERTENSION. CEREBROVASCULAR ACCIDENT 1992 SECONDARY TO SEVERE HYPOTENSION FROM MEDICATIONS. ONLY RESIDUAL IS MILD DROOPING RIGHT LOWER LIP. CROHN\u00bfS DISEASE STATUS POST COLON RESECTION AND DIVERTING ILEOSTOMY FOR STRICTURE 12/13. FUNCTIONING RENAL TRANSPLANT (STATUS POST LIVING DONOR TRANSPLANT 1996). PHARMACOLOGIC IMMUNOSUPPRESSION (FOR RENAL TRANSPLANT AND CROHN\u00bfS DISEASE). ANXIETY. PAST SURGICAL HISTORY: COLON RESECTION (WITH DIVERTING ILEOSTOMY 12/13). PERITONEAL DIALYSIS CATHETER PLACEMENT 1994 AND REMOVAL SECONDARY TO INFECTION 1996. RENAL TRANSPLANT (1996). PERMACATH INSERTION FOR SHORT TERM HEMODIALYSIS PRIOR TO TRANSPLANT 1996. SOCIAL HISTORY: ALCOHOL USE: OCCASIONAL. TOBACCO USE: NEVER. DRUG USE: DENIES. WEIGHT 82.8 KILOGRAMS, BMI 24.1. CURRENT MEDICATIONS: CERTOLIZUMAB, CYCLOSPORINE, SULFAMETHOXAZOLE-TRIMETHOPRIM. ELECTROCARDIOGRAM: PERFORMED: (B)(6) 2013, NORMAL SINUS RHYTHM, HEART RATE: 93, PROLONGED QT. IMPRESSION: PATIENT ASSESSED AND APPROPRIATE FOR ELECTIVE SURGERY WITH THE FOLLOWING CONSIDERATIONS: CROHN\u00bfS DISEASE, KIDNEY TRANSPLANT, AND HYPERTENSION. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. ANESTHESIA RECORD. SURGERY PLANNED: ILEOSTOMY CLOSURE. HISTORY OF PRESENT ILLNESS: HISTORY OF CROHN\u00bfS DISEASE FOR ILEOSTOMY CLOSURE. CURRENT MEDICATIONS: CERTOLIZUMAB, CYCLOSPORINE, SULFAMETHOXAZOLE-TRIMETHOPRIM. LAB: WHITE BLOOD CELL COUNT 4.2. ASA CLASS: 3. WEIGHT 182.16 POUNDS. PLAN: GENERAL ENDOTRACHEAL INTUBATION. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 63-YEAR-OLD PATIENT OF MY PARTNER, (B)(6), WHO UNDERWENT A HEMICOLECTOMY FOR CROHN DISEASE AND DIVERTING LOOP ILEOSTOMY. HE HAS UNDERGONE HIS PREOPERATIVE WORKUP, INCLUDING GASTROGRAFIN ENEMA, REVEALING NO EVIDENCE OF LEAK OR STRICTURE, AND THUS DESIRES TAKEDOWN OF HIS LOOP ILEOSTOMY. THE RISKS, BENEFITS, AND ALTERNATIVES OF THE PROCEDURE WERE DISCUSSED WITH THE PATIENT PREOPERATIVELY. WRITTEN INFORMED CONSENT WAS OBTAINED AFTER ALL OF HIS QUESTIONS WERE ANSWERED. IMPLANT #1 PROCEDURE: 1) EXTRACORPOREAL LOOP ILEOSTOMY CLOSURE WITH A HAND-SEWN SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS. 2) VICRYL MESH SUBLAY, FOLLOWED BY A GORE BIO-A HERNIA PLUG FASCIAL REINFORCEMENT SUBLAY FOR FASCIAL CLOSURE. IMPLANT: GORE\u00ae BIO-A\u00ae HERNIA PLUG [HP01/12116048]. IMPLANT DATE: (B)(6) 2014 (HOSPITALIZATION (B)(6) 2014). (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. PREOPERATIVE DIAGNOSES: 1) ILEOSTOMY STATUS. 2) HISTORY OF CROHN DISEASE, STATUS POST LEFT HEMICOLECTOMY. 3) HISTORY OF KIDNEY TRANSPLANT. 4) HISTORY OF HYPERTENSION. POSTOPERATIVE DIAGNOSES: 1) ILEOSTOMY STATUS. 2) HISTORY OF CROHN DISEASE, STATUS POST LEFT HEMICOLECTOMY. 3) HISTORY OF KIDNEY TRANSPLANT. 4) HISTORY OF HYPERTENSION. ATTENDING SURGEON WAS PRESENT AND PARTICIPATED IN THE ENTIRE PROCEDURE. ESTIMATED BLOOD LOSS: 50 CC. RESIDENT SURGEON: SARAH FISHER, MD. SPECIMEN: ILEOSTOMY TRIM. DRAINS: NONE. FINDINGS: INCLUDED THE EFFERENT LIMB OF THE SMALL BOWEL WAS ADHERENT TO THE LATERAL SIDE WALL, CLOSE TO WHERE THE KIDNEY TRANSPLANT INCISION WAS AND COULD NOT BE VERY EASILY MOBILIZED; HENCE, WE CREATED A HAND-SEWN ANASTOMOSIS AS OPPOSED TO A STAPLED ANASTOMOSIS. PROCEDURE IN DETAIL: \u00bfTHE PATIENT WAS BROUGHT TO THE OPERATING ROOM, PLACED ON THE OPERATING ROOM TABLE IN THE SUPINE POSITION. SEQUENTIAL COMPRESSION HOSE WERE PLACED ON THE PATIENT\u00bfS LOWER EXTREMITIES. GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED PER THE ANESTHESIOLOGY TEAM. THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE OSTOMY WAS SEWN SHUT PREOPERATIVELY WITH 3-0 SILK SUTURE. A CALL TO ORDER WAS PERFORMED. THE PATIENT WAS GIVEN ANCEF AND FLAGYL INTRAVENOUSLY PER SCIP PROTOCOL. WE BEGAN THE PROCEDURE BY CREATING A PERISTOMAL INCISION USING THE CUT FUNCTION OF THE BOVIE AND SUBSEQUENTLY CAREFULLY LYSED ALL OF THE ADHESIONS OF THE OSTOMY TO THE SURROUNDING SUBCUTANEOUS TISSUES ALL THE WAY DOWN TO THE LEVEL OF THE FASCIA. ADHESIONS TO THE FASCIA WERE CAREFULLY TAKEN DOWN USING BOVIE ELECTROCAUTERY. WE WERE ABLE TO MOBILIZE A SIGNIFICANT AMOUNT OF SMALL BOWEL OUT OF THE FASCIA FOR AN ANASTOMOSIS; HOWEVER, THE EFFERENT LIMB WAS ADHERENT INTRA-ABDOMINALLY TO THE LATERAL SIDEWALL OF THE PATIENT\u00bfS ABDOMEN, IN SUCH A LOCATION THAT IT WOULD BE VERY DIFFICULT TO MOBILIZE FURTHER. IN LIGHT OF THIS, WE ELECTED TO NOT PERFORM A STAPLED ANASTOMOSIS AND RATHER OPTING FOR A HAND-SEWN, ANTIPERISTALTIC SIDE-TO-SIDE FUNCTIONAL END-TO-END. THE ILEOSTOMY TRIM WAS TRANSECTED USING A SINGLE LOAD OF THE GIA 75 STAPLER BLUE LOAD AND THE STAPLE LINES WERE OVERSEWN USING 3-0 VICRYL LEMBERT SUTURES. WE THEN CREATED A HAND-SEWN ANASTOMOSIS IN 2 LAYERS USING 3-0 VICRYL POP LEMBERT SUTURES FOR THE BACK ROW AND RUNNING 3-0 PDS FOR THE INNER LAYER, FOLLOWED BY AN INTERRUPTED 3-0 LEMBERT LAYER IN FRONT ROW. WHEN WE COMPLETED THE ANASTOMOSIS, IT WAS PATENT, IT WAS WELL PERFUSED AND NOT ON ANY TENSION. WE THEN PROCEEDED TO CLOSE THE MESENTERIC DEFECT USING A 3-0 VICRYL RUNNING SUTURE, AND WE SUBSEQUENTLY DELIVERED THE ANASTOMOSIS BACK INTO THE ABDOMEN. HAVING DONE THIS, WE THEN PROCEEDED TO CLOSE THE FASCIA. THE FASCIAL CLOSURE WAS PERFORMED IN THE FOLLOWING MANNER: A SINGLE SHEET OF VICRYL MESH WAS FOLDED SUCH THAT IT WAS A 4 PLY. IT WAS DELIVERED INTO THE PERITONEAL CAVITY, SUCH THAT IT PROTECTED THE ANASTOMOSIS AND THE UNDERLYING VISCERA. WE THEN PROCEEDED TO TAKE A GORE BIO-A HERNIA PLUG AND DELIVER IT INTO THIS FASCIAL DEFECT AS WELL, SUCH THAT THE ARMS OF THE PLUG FACED INWARD. WE TOOK #1 NONLOOPED PDS AND PLACED INTERRUPTED SUTURES, ANCHORING THE BIO-A PLUG AT THE CORNERS OF THE FASCIAL CLOSURE. THE FASCIAL DEFECT APPEARED TO BE LONGITUDINALLY ORIENTED AND APPEARED TO CLOSE ON THE LEAST AMOUNT OF TENSION THAT WAY AND THIS WAS CLOSED IN A LONGITUDINAL FASHION USING INTERRUPTED #1 PDS SUTURES X4. ONCE THESE SUTURES WERE IN, BEFORE TYING THEM DOWN, WE VERIFIED BEYOND A SHADOW OF A DOUBT, THAT THERE WAS NO LOOP BOWEL ADJACENT TO THE CLOSURE AND SUBSEQUENTLY TIED THESE DOWN. ONCE THIS WAS DONE, WE PLACED 2 INTERRUPTED, BURIED, SUBCUTICULAR 4-0 MONOCRYL STITCHES. THE SKIN CLOSURE ALSO APPEARED TO SIT ON THE LEAST AMOUNT OF TENSION IN THE VERTICAL ORIENTATION AND THUS, WE LEFT IT LONGITUDINALLY CLOSED AND WE PACKED IN BETWEEN USING 4X4 GAUZE. A STERILE DRESSING WAS PLACED ON THIS. THE PATIENT TOLERATED THE PROCEDURE WELL. ALL COUNTS WERE CORRECT. I, (B)(6), THE ATTENDING, WAS PRESENT AND PARTICIPATED FOR THE ENTIRE PROCEDURE.\u00bf (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD; (B)(6), MD. BRIEF OPERATIVE NOTE. COLORECTAL ABDOMINAL BRIEF OP. I WAS PRESENT AND PARTICIPATED IN THE ENTIRE PROCEDURE. CIH. ASSISTANT SURGEON: (B)(6); MS-3. TYPE OF SURGERY: ELECTIVE. PRIMARY DIAGNOSIS: CROHN\u00bfS. CROHN\u00bfS DISEASE INDICATION: HISTORY OF COLONIC STRICTURE S/P RESECTION WITH DIVERTING LOOP ILEOSTOMY, DESIRES INTESTINAL CONTINUITY. PRIOR ABDOMINAL SURGICAL HISTORY: COLONIC OR RECTAL RESECTION: LAP. COMMENT: LRRT. CURRENT OPERATION: COLORECTAL SURGERY IS PRIMARY, TEMPORARY DIVERSION NOT PERFORMED. MODE: OPEN. PRIMARY PROCEDURE: ILEOSTOMY REVERSAL. WAS AN ANTI-ADHESION BARRIER MATERIAL USED? NO ANTI-ADHESION BARRIER MATERIAL USED. COMMENT: VICRYL MESH UNDERLAY AND BIO-A PATCH REINFORCED FASCIAL REPAIR. SECONDARY PROCEDURE: THERE WAS NOT ANOTHER PROCEDURE UNRELATED TO THE PRIMARY DX PERFORMED BY COLORECTAL SURGERY. REMICADE / ANTIBODY THERAPY: PATIENT RECEIVED REMICADE [SIC] OR ANTIBODY THERAPY FOR INFLAMMATORY BOWEL DISEASE IN LAST TWO MONTHS, CIMZIA STOPPED (B)(6) 2014. PRE-OP DIAGNOSIS: ILEOSTOMY; DESIRES INTESTINAL CONTINUITY. POST-OP DIAGNOSIS: ILEOSTOMY, DESIRES INTESTINAL CONTINUITY. PROCEDURE: ILEOSTOMY REVERSAL. FINDINGS: ILEOSTOMY MOBILIZED, TWO LAYER SIDE TO SIDE HAND SEWN ANASTOMOSIS. ANESTHESIA: GENERAL. URINE OUTPUT: 200 ML. FLUIDS: CRYSTALLOID 2,000 ML. SPECIMEN/TISSUE REMOVED: OSTOMY. ESTIMATED BLOOD LOSS: 15 ML. DRAINS: NONE. COMPLICATIONS: NONE. (B)(6) 2014: (B)(6). IMPLANT LOG. ENTRY 1: ETHICON MESH VICRYL. (B)(6) 2014: (B)(6) HOSPITAL. IMPLANT LOG. ENTRY 2: TYPE: IMPLANT. DESCRIPTION: PLUG BIOABSORBABLE HERNIA. CATALOG NUMBER: HP01. LOT NUMBER: 12116048. MANUFACTURER: W.L. GORE. QUANTITY: 1. EXPIRATION DATE: 10/31/16. IMPLANT SITE: PERITONEUM. IMPLANTED OR EXPLANTED BY: PRIMARY SURGEON. CULTURED: NO. (B)(6) 2014: (B)(6) HOSPITAL. IMPLANT STICKER. GORE\u00ae BIO-A\u00ae HERNIA PLUG. REF CATALOGUE NUMBER: HP01. LOT BATCH CODE: 12116048. USE BY: 2016-10. THE RECORDS CONFIRM A GORE\u00ae BIO-A\u00ae HERNIA PLUG (HP01/12116048) WAS IMPLANTED DURING THE PROCEDURE. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD, PATHOLOGIST. PATHOLOGY. ACC #: (B)(4). FINAL PATHOLOGIC DIAGNOSIS: ILEUM, ILEOSTOMY TRIM, RESECTION: ILEUM WITH FOCAL SUBMUCOSAL AND SUBSEROSAL FIBROSIS. COMPATIBLE WITH AN ILEOSTOMY SITE. ASSISTED BY: (B)(6), MD, RESIDENT. CLINICAL HISTORY: NONE PROVIDED. SPECIMEN(S) RECEIVED: A: ILEOSTOMY TRIM. (B)(6)DESCRIPTION: THE SPECIMEN IS RECEIVED IN FORMALIN, LABELED WITH THE PATIENT\u00bfS NAME AND MEDICAL RECORD NUMBER DESIGNATED \u00bfILEOSTOMY TRIM\u00bf ON THE CONTAINER AND CONSISTS OF TWO SEGMENTS OF SMALL BOWEL (1.6 AND 1.4 CM IN LENGTH, 1.8 CM IN DIAMETER EACH) THAT HAVE AN OPENED COMMUNICATION WITH AN OSTOMY SITE THROUGH THE SKIN (3.2 X 2.2 CM). THE BOWEL MARGINS ARE SEALED BY METALLIC STAPLE LINES. THE BOWEL MUCOSA IS UNREMARKABLE. DICTATED BY PA ANDREW BALICKI. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6). RADIOLOGY-XR ABDOMEN 1 VIEW (KUB). INDICATION: BOWEL OBSTRUCTION, STATUS POST END ILEOSTOMY REVERSAL. IMPRESSION: CLUSTER OF DILATED LOOPS OF SMALL BOWEL OVER THE LEFT HEMIABDOMEN, IF THERE IS CLINICAL CONCERN FOR OBSTRUCTION THEN CT ABDOMEN IS RECOMMENDED. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-CT ABDOMEN/PELVIS WITHOUT INTRAVENOUS CONTRAST. INDICATION: BOWEL OBSTRUCTION. CROHN\u00bfS DISEASE STATUS POST LEFT COLECTOMY WITH DIVERTING ILEOSTOMY IN (B)(6) 2013. ILEOSTOMY REVERSAL (B)(6) 20, 2014. FINDINGS: CT ABDOMEN WITHOUT CONTRAST: DIFFUSELY DILATED SMALL BOWEL LOOPS TRANSITIONING TO DECOMPRESSED DISTAL ILEUM AT THE LEVEL OF THE ILEOSTOMY TAKEDOWN (IMAGE 42 OF SERIES 2). SUPERFICIAL TO THE TRANSITION POINT, THERE IS MESH MATERIAL WITH INTERMIXED FOCI OF GAS. THE COLON IS DECOMPRESSED BUT DOES CONTAIN ENTERIC CONTRAST. PATENT DISTAL COLON ANASTOMOSIS. NO PNEUMOPERITONEUM OR ASCITES. NO PNEUMATOSIS. CT PELVIS WITHOUT CONTRAST: POSTOPERATIVE CHANGES IN THE RIGHT UPPER QUADRANT ABDOMINAL WALL AT THE FORMER ILEOSTOMY SITE. IMPRESSION: 1) DIFFUSELY DILATED SMALL BOWEL LOOPS WITH TRANSITION POINT AT THE LEVEL OF THE ILEOSTOMY TAKEDOWN IN THE RIGHT UPPER QUADRANT INDICATIVE OF AT LEAST PARTIAL SMALL BOWEL OBSTRUCTION AS CONTRAST IS ABLE TO TRAVERSE THE AREA OF TRANSITION TO REACH THE COLON. NO EVIDENCE OF BOWEL PERFORATION OR ISCHEMIA. 2) POSTOPERATIVE FINDINGS STATUS POST RIGHT UPPER QUADRANT ILEOSTOMY TAKEDOWN AND MESH REPAIR WITH FOCI OF GAS AND FLUID INTERMIXED WITH THE MESH, LIKELY POSTOPERATIVE CHANGE. HOWEVER, SUPERIMPOSED INFECTION CANNOT BE EXCLUDED. CORRELATE CLINICALLY. 3) STATUS POST LEFT HEMICOLECTOMY WITH PATENT COLOCOLONIC ANASTOMOSIS. 4) ATROPHIC NATIVE KIDNEY. RIGHT LOWER QUADRANT TRANSPLANT KIDNEY WITHOUT HYDRONEPHROSIS OR PERITRANSPLANT COLLECTION. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-XR THORACOABDOMEN HIGH KUB. INDICATION: HISTORY OF COLONIC STRICTURE, HISTORY OF ILEOSTOMY, POSTOP DAY 6 STATUS POST END ILEOSTOMY TAKEDOWN, BOWEL OBSTRUCTION. IMPRESSION: 1) INTERVAL PLACEMENT OF NASOGASTRIC TUBE WITH SIDE-PORT PAST THE EXPECTED LOCATION OF THE GASTROESOPHAGEAL JUNCTION. 2) SLIGHT INTERVAL IMPROVEMENT IN POSTSURGICAL ILEUS. 3) STABLE LEFT RENAL CALCULUS. (B)(6) 2014: (B)(6) HOSPITAL. (B)(6), MD. RADIOLOGY-XR ABDOMEN 1 VIEW (KUB). INDICATION: BOWEL OBSTRUCTION. IMPRESSION: STABLE APPEARANCE OF DILATED LOOPS OF SMALL BOWEL, CORRELATING TO ONGOING PARTIAL SMALL BOWEL OBSTRUCTION AS SEEN ON PRIOR CT ABDOMEN. RELEVANT MEDICAL INFORMATION: (B)(6) 2015: (B)(6) HOSPITAL. (B)(6), MD. ANESTHESIA RECORD. SURGERY PLANNED: LAPAROSCOPIC UMBILICAL HERNIA REPAIR. CURRENT MEDICATIONS: GENGRAF, HUMIRA PEN, ISONIAZID. ABDOMINAL BINDER: WEAR ABDOMINAL BINDER TO PREVENT HERNIA FROM GROWING IN SIZE. LAB: WHITE BLOOD CELL COUNT 5.4. ASA CLASS: 3. WEIGHT 182.38 POUNDS, BMI 24.1. PLAN: GENERAL ENDOTRACHEAL INTUBATION. (B)(6) 2015: (B)(6) HOSPITAL. (B)(6), MD. OPERATIVE REPORT. TEACHING ASSISTANT: (B)(6), MD (CHIEF RESIDENT). FIRST ASSISTANT: (B)(6), MD (PGY3). PREOPERATIVE DIAGNOSES: 1) INCISIONAL HERNIA. 2) STATUS POST RENAL TRANSPLANTATION. 3) PRIOR HISTORY OF END-STAGE RENAL DISEASE WITH PRIOR HISTORY OF APPENDECTOMY. POSTOPERATIVE DIAGNOSES: 1) INCISIONAL HERNIA. 2) STATUS POST RENAL TRANSPLANTATION. 3) PRIOR HISTORY OF END-STAGE RENAL DISEASE WITH PRIOR HISTORY OF APPENDECTOMY. OPERATIVE PROCEDURE: 1) LAPAROSCOPIC LYSIS OF ADHESIONS LASTING APPROXIMATELY 90 MINUTES FOR REDUCTION OF CHRONICALLY INCARCERATED SMALL BOWEL FROM INCISIONAL HERNIA DEFECT. 2) LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH 15 CM ROUND COMPOSITE SYMBOTEX MESH (6 TRANSFASCIAL SUTURES, ABSORBABLE TACKS). ANESTHESIA: GENERAL ENDOTRACHEAL ANESTHESIA. IV FLUIDS: 1500 ML OF CRYSTALLOID. ESTIMATED BLOOD LOSS: LESS THAN 50 ML. URINE OUTPUT: 325 ML. COMPLICATIONS: NONE. COUNTS: INSTRUMENT AND TOWEL COUNTS AT THE END OF THE CASE. SPECIMEN: NONE. DRAINS: NONE. FINDINGS: PATIENT WAS NOTED TO HAVE SMALL BOWEL CHRONICALLY INCARCERATED IN THE INCISIONAL HERNIA DEFECT WITH SIDE ADHESIONS THROUGHOUT THE ABDOMEN. INDICATION FOR PROCEDURE: THE PATIENT IS A 65-YEAR-OLD, AFRICAN AMERICAN MALE WITH A HISTORY OF RENAL TRANSPLANTATION WHO DEVELOPED AN INCISIONAL HERNIA DEFECT THAT WAS CAUSING HIM PROGRESSIVE DISCOMFORT. THIS WAS NOT ALONG HIS PRIOR TRANSPLANTATION SITE, BUT ALONG THE MIDLINE. HE THEREFORE PRESENTED TO THE OPERATING ROOM FOR REPAIR OF THE DEFECT. DESCRIPTION OF PROCEDURE: \u00bfAFTER INFORMED CONSENT WAS OBTAINED FROM THE PATIENT, THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND PLACED IN THE SUPINE POSITION. THE PATIENT RECEIVED 2 G OF ANCEF INTRAVENOUSLY WITHIN 30 MINUTES OF ANY INCISIONS, AND HAD BILATERAL SEQUENTIAL COMPRESSION DEVICES IN PLACE FOR DEEP VENOUS THROMBOSIS PROPHYLAXIS. GENERAL ENDOTRACHEAL ANESTHESIA WAS INDUCED, AND THE PATIENT WAS PREPPED AND DRAPED IN A STANDARD STERILE SURGICAL FASHION WITH A FOLEY CATHETER IN PLACE AND LEFT ARM TUCKED. HE HAD AN IOBAN DRESSING OVER HIS ABDOMEN. THE PATIENT\u00bfS ABDOMEN WAS ENTERED BENEATH THE LEFT COSTAL MARGIN UTILIZING A 10/12 OPTICAL VIEWING TROCAR. THE ABDOMEN WAS INSUFFLATED TO 15 MMHG WITHOUT DIFFICULTY, AND PLACING A LAPAROSCOPE IN THE ABDOMEN CONFIRMED NO INJURY TO UNDERLYING VISCERAL STRUCTURES UPON ENTRANCE INTO THE ABDOMEN. THERE WERE ADHESIONS WIDELY ALONG THE PATIENT\u00bfS CENTRAL ABDOMEN. UNDER DIRECT VISUALIZATION A 5 MM TROCAR WAS PLACED IN THE BISUBCOSTAL POSITION. THESE TROCARS WERE USED TO THEN PERFORM METICULOUS LYSIS OF ADHESIONS FOR REDUCTION OF CHRONICALLY INCARCERATED SMALL BOWEL FROM THE PATIENT\u00bfS INCISIONAL HERNIA DEFECT. MOST OF THE ADHESIONS WERE THIN AND FILMY, AND EASILY SWEPT DOWN. SOME HYDRODISTENTION WAS DONE SAFELY TO TAKE BOWEL DOWN OFF THE ANTERIOR ABDOMINAL WALL. THIS ALLOWED VISUALIZATION ALL THE WAY TO THE POINT THAT HIS TRANSPLANTED KIDNEY COULD BE SEEN IN THE RIGHT LOWER QUADRANT. THE ABDOMEN WAS WIDELY SURVEYED UPON COMPLETION OF ADHESIOLYSIS, AND THERE WAS NO EVIDENCE OF INADVERTENT ENTERIC INJURY OR PERSISTENT BLEEDING. THE HERNIA DEFECT MEASURED APPROXIMATELY 7 CM IN WIDTH AND 9 CM IN LENGTH. THEREFORE IN ORDER TO OBTAIN REASONABLE CIRCUMFERENTIAL COVERAGE OF AT LEAST 3 CM IN ALL DIRECTIONS, A 15 CM ROUND PIECE OF COMPOSITE SYMBOTEX MESH WAS OBTAINED. THIS WAS ANCHORED IN 4 QUADRANTS ALONG THE POLYESTER ASPECT OF THE MESH WITH A 0 GORE SUTURE. THE MESH WAS MOISTENED AND INTRODUCED INTO THE ABDOMEN. IT WAS SUTURE PASSED THROUGH AND THROUGH THE ANTERIOR ABDOMINAL WALL IN 4 QUADRANTS AND ABSORBABLE TACKS WERE THEN PLACED CIRCUMFERENTIALLY. FOR ADDITIONAL FIXATION, AN ADDITIONAL TRANSFASCIAL SUTURE WAS PLACED IN THE EPIGASTRIC REGION AS WELL AS IN THE RIGHT LOWER QUADRANT, THE 2 AREAS THAT APPEARED WHERE HERNIA RECURRENCE WOULD POTENTIALLY BE MORE LIKELY. AGAIN ABDOMEN WAS WIDELY SURVEYED. THE MESH LAY TAUTLY AGAINST THE ANTERIOR ABDOMINAL WALL UPON DESUFFLATION. THE TROCARS WERE ALL REMOVED. THE SKIN OF ALL PORT SITES WAS CLOSED WITH RUNNING 4-0 MONOCRYL SUBCUTICULAR STITCH. DERMABOND WAS PLACED OVER ALL SITES. DERMABOND WAS ALSO PLACED ON THE SUTURE PASS SITE. THERE WERE NO APPARENT COMPLICATIONS DURING THE CASE, AND AS THE ATTENDING SURGEON, I WAS PRESENT AND SCRUBBED FOR THE ENTIRE OPERATION.\u00bf (B)(6) 2015: (B)(6) HOSPITAL. (B)(6), MD; (B)(6), MD. BRIEF OP NOTE. ASSISTANT SURGEON: (B)(6). PRE-OP DIAGNOSIS: UMBILICAL HERNIA. POST-OP DIAGNOSIS: SAME AS PRE-OP. PROCEDURE: LAPAROSCOPIC UMBILICAL HERNIA REPAIR WITH MESH. FINDINGS: MODERATE ADHESIONS TO ABDOMINAL WALL, UMBILICAL HERNIA MEASURING 5X9CM. ANESTHESIA: GENERAL. SPECIMEN/TISSUE REMOVED: NONE. ESTIMATED BLOOD LOSS: 20 ML. DRAINS: NONE. COMPLICATIONS: NONE. (B)(6) 2015: (B)(6) HOSPITAL. IMPLANT LOG. MESH SYMBOTEX." }, { "mdr_text_key": "205897845", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IT SHOULD BE NOTED THAT THE GORE\u00ae BIO-A\u00ae HERNIA PLUG INSTRUCTIONS FOR USE ADDRESSES THE FOLLOWING ADVERSE REACTIONS AMONG OTHERS: \u00bfPOSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY TISSUE DEFICIENCY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, CONTAMINATION, INFECTION, INFLAMMATION, ADHESION, FISTULA FORMATION, SEROMA FORMATION, HEMATOMA, AND RECURRENCE.\" THE GORE\u00ae BIO-A\u00ae HERNIA PLUG INSTRUCTIONS FOR USE ALSO STATES: \u00bfSTRICT ASEPTIC TECHNIQUES SHOULD BE FOLLOWED. IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE MATERIAL.\"" }, { "mdr_text_key": "205897846", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE\u00ae BIO-A\u00ae HERNIA PLUG WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF PREVIOUS GORE MESH DUE TO EROSION TO THE COLON, SMALL BOWEL RESECTION DUE TO DENSE EROSION, GORE MESH WAS NOT INCORPORATED, INFECTION, EXTENSIVE ADHESIONS FROM MESH TO COLON FISTULA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "P.O. BOX 1408", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86004", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/17/2020;04/01/2021;03/09/2023" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "1416980-2020-05932", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200923", "manufacturer_address_2": "", "pma_pmn_number": "NI", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200923", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200923", "brand_name": "FLOSEAL", "generic_name": "AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED", "manufacturer_d_name": "BAXTER HEALTHCARE CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "DEERFIELD", "manufacturer_d_state": "IL", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NA", "catalog_number": "NI", "lot_number": "NI", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LMF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Agent, Absorbable Hemostatic, Collagen Based", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4490", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/29/2020", "manufacturer_contact_country": "", "date_changed": "20230511", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200923", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "72 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula" ] } ], "distributor_city": "", "date_report": "20200929", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10577400", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200828", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "314994512", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTION, H10: THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "208311026", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CASE STUDY: CHIERIGO, P., MOJTABA RAHMATI. \u00bfTRATTAMENTO CONSERVATIVO DI FISTOLA CALICEALE PERSISTENTE SECONDARIA AD ENUCLEORESEZIONE RENALE. DESCRIZIONI DI UN CASO E CONSIDERAZIONI CLINICHE\u00bf, VOL 77, ISSUE 3, 2010. THERAPY DATES - START DATE, THERAPY DATE: THE STUDY WAS CONDUCTED ON AN UNREPORTED DATE IN (B)(6) 2010. (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "208311027", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A PATIENT UNDERWENT A LEFT RENAL TUMOR EXCISION (3.5 X 3 CM) DURING TEMPORARY RENAL ARTERY OCCLUSION WITH SURFACE HYPOTHERMIA IN WHICH FLOSEAL WAS USED. INTRA-OPERATIVELY A URETERAL STENT WAS PLACED. IT WAS REPORTED VISUAL EXAMINATION OF THE SURGICAL CAVITY DID NOT REVEAL ANY CALYCEAL OPENING. ELECTROCAUTERIZATION WAS PERFORMED, AND THE CAVITY WAS \u00bfSTUFFED\u00bf WITH FLOSEAL. SURGICAL EDGES WERE \u00bfFREE FROM ILLNESS\u00bf. FIVE DAYS POST-OPERATIVELY, URINARY LEAKAGE FROM THE DRAINAGE TUBE INCREASED. ON AN UNREPORTED DATE, A PYELOGRAPHY WAS PERFORMED, AND THE RESULT SHOWED A CALYCEAL FISTULA. A FURTHER STENT WAS PLACED WITH NO RESULTS. THE BLADDER CATHETER WAS KEPT IN PLACE FOR \u00bfAROUND TWO MONTHS\u00bf. IT WAS REPORTED THAT URINARY LEAKAGE STOPPED 34 DAYS FOLLOWING SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/29/2020" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-08110", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200929", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160829", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "NL", "manufacturer_contact_area_code": "951", "date_added": "20200929", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200929", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200929", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200929", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10603283", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200909", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "209122761", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WAS NOT PROVIDED. THE REPORTED PATIENT EFFECT OF THROMBOSIS AND MYOCARDIAL INFARCTION ARE LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "209122762", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT ON (B)(6) 2016, AN ABSORB SCAFFOLD WAS IMPLANTED IN AN UNSPECIFIED ARTERY. TWO DAYS POST SCAFFOLD IMPLANTATION, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND IN-STENT THROMBOSIS WAS NOTED. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-08245", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201002", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "BE", "manufacturer_contact_area_code": "951", "date_added": "20201002", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201002", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201002", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201002", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10623825", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200915", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "209780370", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT: ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS, AND MYOCARDIAL INFARCTION, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE \u00bfBIOSOLVE-IV-REGISTRY: SAFETY AND PERFORMANCE OF THE MAGMARIS SCAFFOLD: 12-MONTH OUTCOMES OF THE FIRST COHORT OF 1,075 PATIENTS\". THE PATIENT DEATHS MENTIONED ARE FILED UNDER ANOTHER MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "209780371", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS IS FILED FOR THE PATIENT EFFECTS. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO THE FOLLOWING: DEATH, THROMBOSIS, MYOCARDIAL INFARCTION, REVASCULARIZATION AND RE-HOSPITALIZATION. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED BIOSOLVE-IV-REGISTRY: SAFETY AND PERFORMANCE OF THE MAGMARIS SCAFFOLD: 12-MONTH OUTCOMES OF THE FIRST COHORT OF 1,075 PATIENTS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-08244", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201002", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140501", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "BE", "manufacturer_contact_area_code": "951", "date_added": "20201002", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201002", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201005", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201002", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20201002", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10623864", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200915", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "209743567", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF DEATH - ESTIMATED. DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT - ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE \u00bfBIOSOLVE-IV-REGISTRY: SAFETY AND PERFORMANCE OF THE MAGMARIS SCAFFOLD: 12-MONTH OUTCOMES OF THE FIRST COHORT OF 1,075 PATIENTS\". THE OTHER SERIOUS ADVERSE EFFECTS MENTIONED ARE FILED UNDER ANOTHER MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "209743568", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS IS FILED FOR THE PATIENT DEATHS: IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO THE FOLLOWING: DEATH, THROMBOSIS, MYOCARDIAL INFARCTION, REVASCULARIZATION AND RE-HOSPITALIZATION. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED BIOSOLVE-IV-REGISTRY: SAFETY AND PERFORMANCE OF THE MAGMARIS SCAFFOLD: 12-MONTH OUTCOMES OF THE FIRST COHORT OF 1,075 PATIENTS. PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-08602", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201014", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20201014", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201014", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/10/2020", "manufacturer_contact_country": "", "date_changed": "20230809", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201014", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ischemia", "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20201127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10680893", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200922", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320336011", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4: THE UNIQUE DEVICE IDENTIFIER (UDI) IS NOT AVAILABLE BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, RESTENOSIS AND ISCHEMIA, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, ELECTRONIC INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "211472821", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ESTIMATED DATE OF EVENT. ESTIMATED DATE OF IMPLANT. THE STENT REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE: \"SCAFFOLD UNDEREXPANSION AND LATE LUMEN LOSS AFTER BIORESORBABLE SCAFFOLD IMPLANTATION: INSIGHTS FROM ABSORB JAPAN TRIAL.\" THE XIENCE STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "211472822", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH PRESENTATION IDENTIFYING ABSORB SCAFFOLDS AND XIENCE STENTS THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, THROMBOSIS, RESTENOSIS, ISCHEMIA, REVASCULARIZATION, REHOSPITALIZATION AND ISSUES WITH STRUT APPOSITION FOR ABSORB SCAFFOLDS AND XIENCE STENTS. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 400 PATIENTS THAT WERE TREATED WITH ABSORB SCAFFOLDS AND XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"SCAFFOLD UNDEREXPANSION AND LATE LUMEN LOSS AFTER BIORESORBABLE SCAFFOLD IMPLANTATION: INSIGHTS FROM ABSORB JAPAN TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/27/2020" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-08850", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201022", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20200928", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "951", "date_added": "20201022", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201022", "brand_name": "ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB GT1", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201022", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Angina", "Stenosis" ] } ], "distributor_city": "", "date_report": "20201022", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10722005", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200928", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "212699273", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF TREATMENT AND IMPLANT: ESTIMATED DATE. UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED DEVICE COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE ABSORB GT1 INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE." }, { "mdr_text_key": "212699274", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE UNSPECIFIED ABSORB GT1 SCAFFOLD WAS IMPLANTED ABOUT 4 YEARS AGO AND RESTENOSIS WAS NOTED ON (B)(6) 2020. THE PATIENT HAD CHEST DISCOMFORT. THE AREA WAS RE-STENTED. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "NJ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "P.O. BOX 151, ROUTE 22 WEST", "manufacturer_contact_pcity": "90821834", "event_type": "Injury", "report_number": "2210968-2020-08469", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201030", "manufacturer_address_2": "", "pma_pmn_number": "K133356", "date_of_event": "20180901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "08876", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9082183429", "noe_summarized": "1", "manufacturer_contact_l_name": "BELLO", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "L" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "908", "date_added": "20201030", "manufacturer_contact_f_name": "ELBA", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201030", "brand_name": "PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT", "generic_name": "SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE", "manufacturer_d_name": "ETHICON INC.", "manufacturer_d_address_1": "P.O. BOX 151, ROUTE 22 WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "SOMERVILLE", "manufacturer_d_state": "NJ", "manufacturer_d_zip_code": "08876", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "08876", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GAW", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Suture, Nonabsorbable, Synthetic, Polypropylene", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5010", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210311", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9082", "patient": [ { "patient_sequence_number": "1", "date_received": "20201030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Fistula" ] } ], "distributor_city": "", "date_report": "20201012", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SOMERVILLE", "mdr_report_key": "10760227", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201012", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ETHICON INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214742035", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE AND PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE AND PDS II SUTURE) USED IN THIS PROCEDURE? WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PLEASE PROVIDE PATIENT DEMOGRAPHICS. CITATION: YONSEI MED J 2018 SEP;59(7):872-878; DOI: HTTPS://DOI.ORG/10.3349/YMJ.2018.59.7.872." }, { "mdr_text_key": "214742036", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "TITLE: FISH-MOUTH CLOSURE OF THE PANCREATIC STUMP AND PARACHUTING OF THE PANCREATIC END WITH DOUBLE U TRANS-PANCREATIC SUTURES FOR PANCREATICO-JEJUNOSTOMY THE STUDY DISCUSSED ABOUT THE FISH-MOUTH CLOSURE OF THE PANCREATIC STUMP AND PARACHUTING OF THE PANCREATIC END WITH DOUBLE U TRANS-PANCREATIC SUTURES FOR PANCREATICO-JEJUNOSTOMY. FROM NOVEMBER 2017, 11 CASES (MALE=7, FEMALE=4; AGE RANGE=47 \u00bf 85 YEARS) OF PYLORUS PRESERVING WHIPPLE\u00bfS OPERATION WITH LEE\u00bfS METHOD WERE PERFORMED. DURING THE PROCEDURE OF MODIFIED BLUMGART\u00bfS ANASTOMOSIS (BA) (LEE\u00bfS METHOD), AT TRANSECTION OF THE PANCREAS AND FISH-MOUTH CLOSURE OF THE STUMP, THE BEVELED EDGE OF THE PANCREATIC STUMP WAS CLOSED WITH INTERRUPTED 4-0 PROLENE VERTICAL MATTRESS SUTURES (ETHICON) (FISH-MOUTH APPROXIMATION), EXCEPT FOR THE AREA AROUND THE MAIN PANCREATIC DUCT (MPD). AT THE POSTERIOR U SUTURE (TRANS-PANCREATIC SUTURE WITH U-SHAPED JEJUNAL SEROMUSCULAR SUTURES), THE PANCREATICO-JEJUNOSTOMY (PJ) ANASTOMOSIS WAS PERFORMED IN TWO LAYERS (INNER PJ DUCT- TO MUCOSA ANASTOMOSIS AND OUTER PJ APPROXIMATION FOR COVER\u00acING THE PANCREATIC CUT STUMP). THE POSTERIOR PART OF THE OUTER LAYER CONSISTS OF TRANS-PANCREATIC HORIZONTAL MATTRESS SUTURES PLACED THROUGH THE PANCREAS APPROXIMATELY 1.5\u00bf2 CM DISTAL FROM THE CUT TRANSECTION EDGE OF THE PANCREAS NECK. DOUBLE-ARMED 3-0 PROLENE SUTURES (ETHICON) (MONOFILAMENT POLYPRO\u00acPYLENE) OR 3-0 PDS (ETHICON) FOR THIS LAYER. AT DUCT-TO-MUCOSA (SECOND INNER LAYER OR PJ), WHILE TOWING THE PENETRATING POSTERIOR U SU\u00acTURES, THE MPD WAS APPROXIMATED TO A SMALL FULL-THICKNESS EN\u00acTEROTOMY IN THE JEJUNUM WITH 5-0 PROLENE (ETHICON) AND/OR 5-0 PDS SUTURES (ETHICON). AT STENT INTO THE PANCREATIC DUCT, THE SHORT SILICONE TUBE WAS FIXED WITH A PRE-TIED POSTERIOR SUTURE AT 6 O\u00bfCLOCK USING 5-0 ABSORBABLE PDS SUTURES (ETHICON). AT ANTERIOR U SUTURE (COMPLETION OF SYMMETRIC DOUBLE U SUTURE), AFTER COMPLETION OF DUCT-TO-MUCOSA PJ ANASTOMOSIS, THE ANTERIOR PJ APPROXIMATION USING THE SAME PREVIOUSLY TIGHTENED 3-0 PROLENE POSTERIOR U SUTURES (ETHICON) IN THE SAME MANNER OF THE HORIZONTAL SEROMUSCULAR MATTRESS SUTURE (ANTERIOR U SUTURE-SECOND SUTURE). AT PARACHUTING THE PANCREAS WITH DOUBLE U SUTURES (HORSE SADDLE SHAPE APPROXIMATION OF THE JEJUNUM OVER THE FISH-MOUTH CLOSED PANCREATIC STUMP), PANCREATICO-JEJUNOSTOMY AFTER THE DOUBLE U SUTURES ARE TIGHTENED WITH 3-0 PROLENE SUTURES (ETHICON) AT A FINAL STEP TO APPROXIMATE THE GLAND AND THE JEJUNUM BY PARACHUTING (HORSE SADDLE SHAPE) WITH TENSION EVENLY DISTRIBUTED ACROSS FOUR SUTURE SITES. REPORTED COMPLICATIONS INCLUDED BIOCHEMICAL LEAK (BL) (N=2) IN WHICH PERIPANCREATIC DRAIN WERE ABLE TO REMOVE ON ABOUT POSTOPERATIVE DAY 7, AND ONE CASE HAD DRAINS FOR 12 DAYS DUE TO POSTOPERATIVE PANCREATIC FISTULA OF BL (N=1) WITHOUT SIGNIFICANT PROBLEMS; TRANSIENT BILE LEAK (N=1); FEVER (N=2); TRANSIENT DELAYER GASTRIC EMPTYING (N=1). IN CONCLUSION, THE NEW METHOD (LEE\u00bfS METHOD) MAY DRAMATICALLY REDUCE THE OCCURRENCE OF POSTOPERATIVE PANCREATIC FISTULA AFTER WHIPPLE\u00bfS OPERATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "08876", "manufacturer_contact_exchange": "908", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "NJ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "P.O. BOX 151, ROUTE 22 WEST", "manufacturer_contact_pcity": "90821834", "event_type": "Injury", "report_number": "2210968-2020-08470", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201030", "manufacturer_address_2": "", "pma_pmn_number": "N18331", "date_of_event": "20180901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "08876", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9082183429", "noe_summarized": "1", "manufacturer_contact_l_name": "BELLO", "source_type": [ "FOREIGN", "HEALTH PROFESSIONAL", "L" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "908", "date_added": "20201030", "manufacturer_contact_f_name": "ELBA", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201030", "brand_name": "PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT", "generic_name": "SUTURE, SURGICAL, ABSORBABLE", "manufacturer_d_name": "ETHICON INC.", "manufacturer_d_address_1": "P.O. BOX 151, ROUTE 22 WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "SOMERVILLE", "manufacturer_d_state": "NJ", "manufacturer_d_zip_code": "08876", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "08876", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NEW", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Suture, Surgical, Absorbable, Polydioxanone", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4840", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210203", "health_professional": "I", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9082", "patient": [ { "patient_sequence_number": "1", "date_received": "20201030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Fistula" ] } ], "distributor_city": "", "date_report": "20201012", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SOMERVILLE", "mdr_report_key": "10760230", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201012", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ETHICON INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214744938", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE AND PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE AND PDS II SUTURE) USED IN THIS PROCEDURE? WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PLEASE PROVIDE PATIENT DEMOGRAPHICS. CITATION: YONSEI MED J 2018 SEP;59(7):872-878; DOI: HTTPS://DOI.ORG/10.3349/YMJ.2018.59.7.872." }, { "mdr_text_key": "214744939", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "TITLE: FISH-MOUTH CLOSURE OF THE PANCREATIC STUMP AND PARACHUTING OF THE PANCREATIC END WITH DOUBLE U TRANS-PANCREATIC SUTURES FOR PANCREATICO-JEJUNOSTOMY THE STUDY DISCUSSED ABOUT THE FISH-MOUTH CLOSURE OF THE PANCREATIC STUMP AND PARACHUTING OF THE PANCREATIC END WITH DOUBLE U TRANS-PANCREATIC SUTURES FOR PANCREATICO-JEJUNOSTOMY. FROM NOVEMBER 2017, 11 CASES (MALE=7, FEMALE=4; AGE RANGE=47 \u00bf 85 YEARS) OF PYLORUS PRESERVING WHIPPLE\u00bfS OPERATION WITH LEE\u00bfS METHOD WERE PERFORMED. DURING THE PROCEDURE OF MODIFIED BLUMGART\u00bfS ANASTOMOSIS (BA) (LEE\u00bfS METHOD), AT TRANSECTION OF THE PANCREAS AND FISH-MOUTH CLOSURE OF THE STUMP, THE BEVELED EDGE OF THE PANCREATIC STUMP WAS CLOSED WITH INTERRUPTED 4-0 PROLENE VERTICAL MATTRESS SUTURES (ETHICON) (FISH-MOUTH APPROXIMATION), EXCEPT FOR THE AREA AROUND THE MAIN PANCREATIC DUCT (MPD). AT THE POSTERIOR U SUTURE (TRANS-PANCREATIC SUTURE WITH U-SHAPED JEJUNAL SEROMUSCULAR SUTURES), THE PANCREATICO-JEJUNOSTOMY (PJ) ANASTOMOSIS WAS PERFORMED IN TWO LAYERS (INNER PJ DUCT- TO MUCOSA ANASTOMOSIS AND OUTER PJ APPROXIMATION FOR COVERING THE PANCREATIC CUT STUMP). THE POSTERIOR PART OF THE OUTER LAYER CONSISTS OF TRANS-PANCREATIC HORIZONTAL MATTRESS SUTURES PLACED THROUGH THE PANCREAS APPROXIMATELY 1.5\u00bf2 CM DISTAL FROM THE CUT TRANSECTION EDGE OF THE PANCREAS NECK. DOUBLE-ARMED 3-0 PROLENE SUTURES (ETHICON) (MONOFILAMENT POLYPROPYLENE) OR 3-0 PDS (ETHICON) FOR THIS LAYER. AT DUCT-TO-MUCOSA (SECOND INNER LAYER OR PJ), WHILE TOWING THE PENETRATING POSTERIOR U SUTURES, THE MPD WAS APPROXIMATED TO A SMALL FULL-THICKNESS ENTEROTOMY IN THE JEJUNUM WITH 5-0 PROLENE (ETHICON) AND/OR 5-0 PDS SUTURES (ETHICON). AT STENT INTO THE PANCREATIC DUCT, THE SHORT SILICONE TUBE WAS FIXED WITH A PRE-TIED POSTERIOR SUTURE AT 6 O\u00bfCLOCK USING 5-0 ABSORBABLE PDS SUTURES (ETHICON). AT ANTERIOR U SUTURE (COMPLETION OF SYMMETRIC DOUBLE U SUTURE), AFTER COMPLETION OF DUCT-TO-MUCOSA PJ ANASTOMOSIS, THE ANTERIOR PJ APPROXIMATION USING THE SAME PREVIOUSLY TIGHTENED 3-0 PROLENE POSTERIOR U SUTURES (ETHICON) IN THE SAME MANNER OF THE HORIZONTAL SEROMUSCULAR MATTRESS SUTURE (ANTERIOR U SUTURE-SECOND SUTURE). AT PARACHUTING THE PANCREAS WITH DOUBLE U SUTURES (HORSE SADDLE SHAPE APPROXIMATION OF THE JEJUNUM OVER THE FISH-MOUTH CLOSED PANCREATIC STUMP), PANCREATICO-JEJUNOSTOMY AFTER THE DOUBLE U SUTURES ARE TIGHTENED WITH 3-0 PROLENE SUTURES (ETHICON) AT A FINAL STEP TO APPROXIMATE THE GLAND AND THE JEJUNUM BY PARACHUTING (HORSE SADDLE SHAPE) WITH TENSION EVENLY DISTRIBUTED ACROSS FOUR SUTURE SITES. REPORTED COMPLICATIONS INCLUDED BIOCHEMICAL LEAK (BL) (N=2) IN WHICH PERIPANCREATIC DRAIN WERE ABLE TO REMOVE ON ABOUT POSTOPERATIVE DAY 7, AND ONE CASE HAD DRAINS FOR 12 DAYS DUE TO POSTOPERATIVE PANCREATIC FISTULA OF BL (N=1) WITHOUT SIGNIFICANT PROBLEMS; TRANSIENT BILE LEAK (N=1); FEVER (N=2); TRANSIENT DELAYER GASTRIC EMPTYING (N=1). IN CONCLUSION, THE NEW METHOD (LEE\u00bfS METHOD) MAY DRAMATICALLY REDUCE THE OCCURRENCE OF POSTOPERATIVE PANCREATIC FISTULA AFTER WHIPPLE\u00bfS OPERATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "08876", "manufacturer_contact_exchange": "908", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3010252479-2020-00135", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20201030", "manufacturer_address_2": "", "pma_pmn_number": "P180025", "date_of_event": "20201006", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20201030", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201030", "brand_name": "MANTA 18F", "generic_name": "VASCULAR CLOSURE DEVICE", "manufacturer_d_name": "ESSENTIAL MEDICAL, INC", "manufacturer_d_address_1": "260 SIERRA DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "EXTON", "manufacturer_d_state": "PA", "manufacturer_d_zip_code": "19341", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "19341", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210908", "model_number": "2115", "catalog_number": "", "lot_number": "MN2001287", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MGB", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00856279007062", "udi_public": "856279007062", "openfda": { "device_name": "Device, Hemostasis, Vascular", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/06/2020", "manufacturer_contact_country": "", "date_changed": "20231011", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201030", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "85 YR", "patient_sex": "", "patient_weight": "86", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Extravasation" ] } ], "distributor_city": "", "date_report": "20201006", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10761867", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201006", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "325346669", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. NO RETURN PRODUCT EVALUATION COULD BE COMPLETED. THE DEVICE LOT HISTORY RECORD REVIEW INDICATED NO NON-CONFORMITIES RELATED TO THIS LOT, THEREFORE, SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION SUBMITTED, FOLLOWING A TAVR PROCEDURE, A MANTA 18F WAS PREPARED TO DEPLOY FOR ACCESS IN THE LEFT COMMON FEMORAL ARTERY. PATIENT ARTERIOTOMY WAS 8.8 X 9MM WITH MODERATE ANTERIOR AND POSTERIOR CALCIFICATION AT THE FEMORAL HEAD AND AN EXTREME AMOUNT OF CALCIFICATION BELOW THE FEMORAL HEAD. MANTA DEPLOYMENT DEPTH WAS MEASURED AT 3.5 + 1. A PRE-DEPLOYMENT ANGIOGRAM REVEALED A HIP PROSTHESIS BLOCKING THE VIEW OF THE ACCESS SITE MAKING IT DIFFICULT TO IDENTIFY WHERE THE SURGEON MADE INITIAL ACCESS. THE SURGEON DECIDED TO DO A BLIND STICK INTO THE GROIN WITHOUT THE USE OF ULTRASOUND. ACTIVATED CLOTTING TIME (ACT) WAS NOTED AT 289. DURING DEPLOYMENT, THE MANTA ANCHOR DID NOT DEPLOY, AND THE COMPLETE MANTA CLOSURE DEVICE PULLED OUT OF THE ACCESS SITE. A SECOND DEVICE WAS THEN INSERTED HOWEVER, UNSUCCESSFUL IN CLOSING THE ACCESS. COPIOUS BLEEDING WAS PRESENT, A CUT DOWN WAS PERFORMED, AN ENDARTERECTOMY OF THE CALCIUM, AND PATCHED THE VESSEL. FOLLOWING THE PROCEDURE, THE SURGEON MENTIONED THIS WAS NOT A MANTA FAILURE, IT WAS TOO HEAVILY CALCIFIED. \"THERE WAS A HUGE ROCK OF CALCIUM THERE\"; AND HAD ACCESSED DIRECTLY INTO CALCIUM ROCK. ADDITIONALLY, POST-PROCEDURE THE SURGEON NOTED ACCESS WAS IN THE LEFT FEMORAL ARTERY 1CM ABOVE THE BIFURCATION. THE IFU WAS REVIEWED AND CONFIRMED TO LIST WARNING: DO NOT USE IN PATIENTS WITH SEVERE CALCIFICATION OF THE ACCESS VESSEL AND/OR COMMON FEMORAL ARTERY STENOSIS RESULTING IN A VESSEL <5MM IN DIAMETER FOR THE 14F MANTA OR <6MM IN DIAMETER FOR THE 18F MANTA, OR >50% DIAMETER FEMORAL OR ILIAC ARTERY STENOSIS. PRECAUTIONS: IF BLEEDING FROM THE FEMORAL ACCESS SITE PERSISTS AFTER THE USE OF THE MANTA DEVICE, THE PHYSICIAN SHOULD ASSESS THE SITUATION. BASED ON THE PHYSICIAN ASSESSMENT OF THE AMOUNT OF BLEEDING, USE MANUAL OR MECHANICAL COMPRESSION, APPLICATION OF BALLOON PRESSURE FROM A SECONDARY ACCESS SITE, PLACEMENT OF A COVERED STENT, AND/OR SURGICAL REPAIR TO OBTAIN HEMOSTASIS. THE FOLLOWING POTENTIAL ADVERSE EVENTS RELATED TO THE DEPLOYMENT OF VASCULAR CLOSURE DEVICES HAVE BEEN IDENTIFIED: OTHER ACCESS SITE COMPLICATIONS LEADING TO BLEEDING, HEMATOMA, PSEUDOANEURYSM, OR ARTERIO-VENOUS FISTULA, POSSIBLY REQUIRING BLOOD TRANSFUSION, SURGICAL REPAIR, AND/OR ENDOVASCULAR INTERVENTION. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ANY LARGE BORE INTERVENTION, INCLUDING THE USE OF THE MANTA VASCULAR CLOSURE DEVICE, INCLUDE BUT ARE NOT LIMITED TO: LATE ARTERIAL BLEEDING, VESSEL LACERATION OR TRAUMA. IF THE MANTA CLOSURE DOES NOT DEPLOY PROPERLY IN THE ARTERY AND HEMOSTASIS IS NOT ACHIEVED, THE CLOSURE AND ALL ABSORBABLE COMPONENTS MAY BE REMOVED FROM THE PATIENT IF MEDICALLY NECESSARY. ACTIVATED CLOTTING TIME (ACT) SHOULD BE BELOW 250 SECONDS PRIOR TO CLOSURE. CONFIRM VIA FEMORAL ARTERIOGRAM: NO EVIDENCE OF SIGNIFICANT PERIPHERAL VASCULAR DISEASE OR CALCIFICATION IN THE REGION OF THE ARTERIOTOMY." }, { "mdr_text_key": "213850108", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE HAS NOT RETURNED FOR EVALUATION AND AN INVESTIGATION HAS BEEN OPENED TO REVIEW DEVICE HISTORY RECORD, AND RISK DOCUMENTATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION." }, { "mdr_text_key": "213850109", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS REPORTED: PHYSICIAN ATTEMPTED TO CLOSE LT COMMON FEMORAL ACCESS WITH 18FR MANTA. ANCHOR DID NOT DEPLOY IN VESSEL AND CAME OUT. REINSERTED A 2ND MANTA DEVICE BUT DID NOT CLOSE ACCESS SITE. LOTS OF BLEEDING AT SITE, PATIENT WENT TO A CUTDOWN. ASSOCIATED TO MDR 3010252479-2020-00134 MANTA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/01/2021" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-09118", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201102", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "AS", "manufacturer_contact_area_code": "951", "date_added": "20201102", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201102", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201103", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201102", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "82 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20201102", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10773318", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201013", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214293289", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF DEATH: ESTIMATED. DATE OF EVENT: ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT: ESTIMATED. THERE WERE NO REPORTED DEVICE MALFUNCTIONS AND THE PRODUCTS WERE NOT RETURNED AS THE SCAFFOLDS REMAIN IN THE ANATOMIES. A REVIEW OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORIES COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED DEATHS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. ARTICLE TITLE: \"LONG-TERM RESULTS OF A PROSPECTIVE, SINGLE-ARM EVALUATION OF EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS IN INFRAPOPLITEAL ARTERIES.\" THE OTHER ADVERSE PATIENT EFFECTS REFERENCED ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "214293290", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING: DEATH, RESTENOSIS, SCAFFOLD THROMBOSIS, OCCLUSION, PSEUDOANEURYSM, TARGET LESION REVASCULARIZATION AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 48 PATIENTS, 55 LIMBS, TREATED WITH 71 ABSORB SCAFFOLDS. DETAILS ARE LISTED IN THE ARTICLE TITLED, \"LONG-TERM RESULTS OF A PROSPECTIVE, SINGLE-ARM EVALUATION OF EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS IN INFRAPOPLITEAL ARTERIES.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09119", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201102", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "AS", "manufacturer_contact_area_code": "951", "date_added": "20201102", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201102", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201102", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "82 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Occlusion", "Thrombosis", "Stenosis", "Pseudoaneurysm" ] } ], "distributor_city": "", "date_report": "20201102", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10773355", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201013", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214774766", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT - ESTIMATED. THERE WERE NO REPORTED DEVICE MALFUNCTIONS AND THE PRODUCTS WERE NOT RETURNED AS THE SCAFFOLDS REMAIN IN THE ANATOMIES. A REVIEW OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORIES COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF RESTENOSIS, THROMBOSIS, OCCLUSION AND PSEUDOANEURYSM, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. ARTICLE TITLE: \"LONG-TERM RESULTS OF A PROSPECTIVE, SINGLE-ARM EVALUATION OF EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS IN INFRAPOPLITEAL ARTERIES\". THE PATIENT EFFECT OF DEATH IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "214774767", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING: DEATH, RESTENOSIS, SCAFFOLD THROMBOSIS, OCCLUSION, PSEUDOANEURYSM, TARGET LESION REVASCULARIZATION AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 48 PATIENTS, 55 LIMBS, TREATED WITH 71 ABSORB SCAFFOLDS. DETAILS ARE LISTED IN THE ARTICLE TITLED, \"LONG-TERM RESULTS OF A PROSPECTIVE, SINGLE-ARM EVALUATION OF EVEROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLDS IN INFRAPOPLITEAL ARTERIES.\" PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09186", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201103", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130805", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "NL", "manufacturer_contact_area_code": "951", "date_added": "20201103", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201103", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201103", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10779911", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214522489", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. SPECIFIC ABSORB DEVICE PART AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED. THE PATIENT DEATHS REFERENCED ARE BEING REPORTED ON A SEPARATE MEDWATCH REPORT #. LITERATURE: THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN REAL-WORLD PRACTICE: LONG-TERM FOLLOW-UP OF THE AMC SINGLE CENTRE REAL WORLD PCI REGISTRY. AS THIS IS A PUBLISHED ARTICLE AND IS ATTACHED TO THE REPORTS, PATIENT INFORMATION IS INCLUDED." }, { "mdr_text_key": "214522490", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD THAT MAY BE RELATED TO DEATH, THROMBUS, MYOCARDIAL INFARCTION AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED, THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN REAL-WORLD PRACTICE: LONG-TERM FOLLOW-UP OF THE AMC SINGLE CENTRE REAL WORLD PCI REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-09187", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201103", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20130805", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "NL", "manufacturer_contact_area_code": "951", "date_added": "20201103", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201103", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201103", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20201103", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10779917", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214402403", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF DEATH HAS BEEN ESTIMATED. THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. SPECIFIC ABSORB DEVICE PART AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECT LISTED IS CONSISTENT WITH THE PRODUCT RISK PROFILE AND IS THEREFORE EXPECTED. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED. LITERATURE: THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN REAL-WORLD PRACTICE: LONG-TERM FOLLOW-UP OF THE (B)(6) REGISTRY. AS THIS IS A PUBLISHED ARTICLE AND IS ATTACHED TO THE REPORTS, PATIENT INFORMATION IS INCLUDED." }, { "mdr_text_key": "214402404", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS IS FILED TO REPORT THE PATIENT DEATH IN THE ARTICLE. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB SCAFFOLD THAT MAY BE RELATED TO DEATH, THROMBUS, MYOCARDIAL INFARCTION AND REVASCULARIZATION. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED, THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD IN REAL-WORLD PRACTICE: LONG-TERM FOLLOW-UP OF THE (B)(6) REGISTRY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-09195", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20201103", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140801", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20201103", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201103", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Difficult or Delayed Activation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/13/2021", "manufacturer_contact_country": "", "date_changed": "20231010", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20210118", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10781402", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214524222", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: ESTIMATED DATE OF EVENT. IMPLANT DATE: ESTIMATED DATE OF IMPLANT. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE MALFUNCTIONS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE ADDITIONAL XIENCE STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. LITERATURE: THE RELATIONSHIP OF PRE-PROCEDURAL DMAX BASED SIZING TO LESION LEVEL OUTCOMES IN ABSORB BVS AND XIENCE EES TREATED PATIENTS IN THE AIDA TRIAL." }, { "mdr_text_key": "214524223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH PRESENTATION IDENTIFYING ABSORB BVS AND XIENCE STENTS THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, REHOSPITALIZATION. DEPLOYMENT DIFFICULTY WAS ALSO NOTED FOR BOTH ABSORB BVS AND XIENCE STENTS. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"THE RELATIONSHIP OF PRE-PROCEDURAL DMAX BASED SIZING TO LESION LEVEL OUTCOMES IN ABSORB BVS AND XIENCE EES TREATED PATIENTS IN THE AIDA TRIAL.\"" }, { "mdr_text_key": "322249245", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.NA" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/18/2021" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2024168-2020-09196", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201103", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20140801", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20201103", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201103", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Improper or Incorrect Procedure or Method", "Difficult or Delayed Activation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/13/2021", "manufacturer_contact_country": "", "date_changed": "20231006", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20210118", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10781432", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "322364304", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IT SHOULD BE NOTED THAT THE IFU STATES: SIZE THE REFERENCE TARGET LESION DIAMETER APPROPRIATELY TO AVOID OVER EXPANDING THE SCAFFOLD TO ENSURE ADEQUATE SCAFFOLD APPOSITION. THIS WILL REDUCE THE RISK OF CAUSING SCAFFOLD DAMAGE. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED DIFFICULTY. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." }, { "mdr_text_key": "216326948", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). ESTIMATED DATE OF EVENT. ESTIMATED DATE OF IMPLANT. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADVERSE EVENTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE ADDITIONAL XIENCE REFERENCED BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. LITERATURE : THE RELATIONSHIP OF PRE-PROCEDURAL DMAX BASED SIZING TO LESION LEVEL OUTCOMES IN ABSORB BVS AND XIENCE EES TREATED PATIENTS IN THE AIDA TRIALNA." }, { "mdr_text_key": "216326949", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH PRESENTATION IDENTIFYING ABSORB BVS AND XIENCE STENTS THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, REHOSPITALIZATION. DEPLOYMENT DIFFICULTY WAS ALSO NOTED FOR BOTH ABSORB BVS AND XIENCE STENTS. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF (B)(4) PATIENTS THAT WERE TREATED WITH XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"THE RELATIONSHIP OF PRE-PROCEDURAL DMAX BASED SIZING TO LESION LEVEL OUTCOMES IN ABSORB BVS AND XIENCE EES TREATED PATIENTS IN THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/18/2021" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09203", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201103", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180617", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201103", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201103", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20201103", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10781738", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214580702", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. SPECIFIC ABSORB DEVICE PART AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE PATIENT EFFECTS LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. LITERATURE. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE ADDITIONAL SCAFFOLD IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "214580703", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 5. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD [BRS] IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". THE PATIENT WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND SUBTOTAL OCCLUSION OF THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH THREE BRS (TWO 3.5/28 MM AND A 3.5/18 MM DEVICES). BECAUSE OF DISSECTION AT THE DISTAL EDGE OF THE DISTAL BRS, A 3.0/9 MM DES WAS IMPLANTED. SURVEILLANCE ANGIOGRAPHY SHOWED MILD RESTENOSIS IN THE MID RCA, WITH NO INDICATION FOR TREATMENT. 532 DAYS AFTER INDEX PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PATIENT SUFFERED A RECURRENT MYOCARDIAL INFARCTION WITH VERY LATE SCAFFOLD THROMBOSIS AND SUBTOTAL THROMBOTIC OCCLUSION WITHIN THE SCAFFOLDED SEGMENT OF THE MID RCA. OPTICAL COHERENCE TOMOGRAPHY SHOWED FOCAL SCAFFOLD DISCONTINUITY IN THE DISTAL BRS WITH OVERLYING THROMBUS AND AN OTHERWISE ACCEPTABLE RESULT IN THE STENTED SEGMENT. IN ADDITION, THERE WAS RESTENOSIS WITH AN OCT-DERIVED PERCENT LUMEN AREA STENOSIS OF 54%. THE LESION WAS TREATED WITH BALLOON DILATION FOLLOWED BY IMPLANTATION OF DES. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09206", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201103", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180617", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201103", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201103", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201103", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "74 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection", "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201103", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10781923", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214609633", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. SPECIFIC ABSORB DEVICE PART AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. A CONCLUSIVE CAUSE FOR THE PATIENT EFFECTS LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. LITERATURE. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE ADDITIONAL SCAFFOLD IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "214609634", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 5. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD [BRS] IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". THE PATIENT WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND SUBTOTAL OCCLUSION OF THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH THREE BRS (TWO 3.5/28 MM AND A 3.5/18 MM DEVICES). BECAUSE OF DISSECTION AT THE DISTAL EDGE OF THE DISTAL BRS, A 3.0/9 MM DES WAS IMPLANTED. SURVEILLANCE ANGIOGRAPHY SHOWED MILD RESTENOSIS IN THE MID RCA, WITH NO INDICATION FOR TREATMENT. 532 DAYS AFTER INDEX PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PATIENT SUFFERED A RECURRENT MYOCARDIAL INFARCTION WITH VERY LATE SCAFFOLD THROMBOSIS AND SUBTOTAL THROMBOTIC OCCLUSION WITHIN THE SCAFFOLDED SEGMENT OF THE MID RCA. OPTICAL COHERENCE TOMOGRAPHY SHOWED FOCAL SCAFFOLD DISCONTINUITY IN THE DISTAL BRS WITH OVERLYING THROMBUS AND AN OTHERWISE ACCEPTABLE RESULT IN THE STENTED SEGMENT. IN ADDITION, THERE WAS RESTENOSIS WITH AN OCT-DERIVED PERCENT LUMEN AREA STENOSIS OF 54%. THE LESION WAS TREATED WITH BALLOON DILATION FOLLOWED BY IMPLANTATION OF DES. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09227", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201104", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180530", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201104", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201104", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201104", "sequence_number_treatment": [ "3.0X28 ABSORB SCAFFOLD (LAD)" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201104", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10786218", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214599868", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED. THE ADDITIONAL DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER." }, { "mdr_text_key": "214599869", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 2. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". A 3.0X28 MM ABSORB SCAFFOLD WAS IMPLANTED IN THE LEFT CIRCUMFLEX CORONARY ARTERY AND A 3.0X28 ABSORB SCAFFOLD WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. PER THE ARTICLE, SIX-MONTH ANGIOGRAPHIC FOLLOW-UP DOCUMENTED A FAVORABLE RESULT IN BOTH LESIONS. 514 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THROMBOTIC OCCLUSION OF THE BIORESORBABLE SCAFFOLD (BRS) IN THE LEFT CIRCUMFLEX (LCX). FLOW WAS RESTORED AFTER BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT. IN ADDITION, THERE WAS DIFFUSE IN-STENT RESTENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY BRS, WHICH WAS ALSO TREATED WITH A DES. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09237", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201104", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180530", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201104", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201104", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201104", "sequence_number_treatment": [ "3.0X28 ABSORB SCAFFOLD" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stenosis" ] } ], "distributor_city": "", "date_report": "20201104", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10787880", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214649619", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING LITERATURE: \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". THE ADDITIONAL DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE UDI IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED." }, { "mdr_text_key": "214649620", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 2. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". A 3.0X28 MM ABSORB SCAFFOLD WAS IMPLANTED IN THE LEFT CIRCUMFLEX CORONARY ARTERY AND A 3.0X28 ABSORB SCAFFOLD WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. PER THE ARTICLE, SIX-MONTH ANGIOGRAPHIC FOLLOW-UP DOCUMENTED A FAVORABLE RESULT IN BOTH LESIONS. 514 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THROMBOTIC OCCLUSION OF THE BIORESORBABLE SCAFFOLD (BRS) IN THE LEFT CIRCUMFLEX (LCX). FLOW WAS RESTORED AFTER BALLOON DILATATION AND IMPLANTATION OF A DRUG ELUTING STENT. IN ADDITION, THERE WAS DIFFUSE IN-STENT RESTENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY BRS, WHICH WAS ALSO TREATED WITH A DES. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09238", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201104", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20181204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201104", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201104", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201104", "sequence_number_treatment": [ "2.5 MM ABSORB SCAFFOLD" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "68 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201104", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10788101", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214653352", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE: ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "214653433", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 3. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS [VLSCT] AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". TWO 2.5 MM ABSORB SCAFFOLDS AND A TOTAL LENGTH OF 36 MM WERE IMPLANTED IN THE RIGHT CORONARY ARTERY. ANGIOGRAPHIC FOLLOW-UP CONFIRMED FAVORABLE RESULTS. 702 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH VLSCT AND THROMBOTIC OCCLUSION OF THE DISTAL SCAFFOLD, WHICH WAS TREATED WITH BALLOON DILATATION AND DRUG ELUTING STENT IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-09243", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201104", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20201104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201104", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/05/2020", "manufacturer_contact_country": "", "date_changed": "20230804", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201104", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "53 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10788499", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214790561", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE REPORTED POTENTIAL ADVERSE EVENTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "214790562", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 1. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". A 3.0X18 MM ABSORB SCAFFOLD WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. PER THE ARTICLE, 393 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) AND VLSCT (VERY LATE SCAFFOLD THROMBOSIS). INTRAPROCEDURAL OCT (OPTICAL COHERENCE TOMOGRAPHY) EXAMINATION SHOWED SCAFFOLD DISCONTINUITY WITH MALAPPOSED STRUTS IN THE VESSEL LUMEN AND OVERLYING THROMBUS. FLOW WAS RESTORED WITH THROMBUS ASPIRATION AND BALLOON DILATATION WITH GOOD ACUTE ANGIOGRAPHIC RESULT. 46 DAYS LATER THE PATIENT SUFFERED RECURRENT VLSCT, THIS TIME UNDER ONGOING DUAL ANTIPLATELET THERAPY WITH PRASUGREL. OCT EXAMINATION OF THE CULPRIT LESION WAS REPEATED AND SHOWED MORE MARKED SCAFFOLD DISCONTINUITY WITH OVERLYING THROMBUS. THE PATIENT WAS TREATED WITH A METALLIC DRUG-ELUTING STENT (DES) WITH GOOD RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "320382284", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED WALL APPOSITION AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. CORRECTED VERBIAGE FROM PREVIOUSLY FILED MDR. REPLACED \"REPORTED DIFFICULTY TO DEPLOY\" WITH \"REPORTED WALL APPOSITION\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-09246", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201104", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190619", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20201104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201104", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Improper or Incorrect Procedure or Method", "Difficult or Delayed Activation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/13/2021", "manufacturer_contact_country": "", "date_changed": "20230901", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201104", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20210118", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10788646", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "214738647", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). DATE OF EVENT: ESTIMATED DATE OF EVENT. DATE OF IMPLANT: ESTIMATED DATE OF IMPLANT. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL XIENCE STENT REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. LITERATURE: THE INFLUENCE OF IMPLANTATION TECHNIQUES ON LESION ORIENTED-OUTCOMES IN ABSORB BVS AND XIENCE EES LESIONS TREATED IN ROUTINE CLINICAL PRACTICE AT COMPLETE THREE YEAR FOLLOW-UP: AIDA TRIAL QCA SUBSTUDY." }, { "mdr_text_key": "214738648", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH PRESENTATION IDENTIFYING ABSORB BVS AND XIENCE STENTS THAT MAY BE RELATED TO THE FOLLOWING: MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION AND REHOSPITALIZATION. DEPLOYMENT DIFFICULTY WAS ALSO NOTED FOR BOTH ABSORB BVS AND XIENCE STENTS, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 1,845 PATIENTS THAT WERE TREATED WITH XIENCE STENTS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"THE INFLUENCE OF IMPLANTATION TECHNIQUES ON LESION ORIENTED-OUTCOMES IN ABSORB BVS AND XIENCE EES LESIONS TREATED IN ROUTINE CLINICAL PRACTICE AT COMPLETE THREE YEAR FOLLOW-UP: AIDA TRIAL QCA SUBSTUDY.\"" }, { "mdr_text_key": "322473392", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. IT SHOULD BE NOTED THAT THE IFU STATES: SIZE THE REFERENCE TARGET LESION DIAMETER APPROPRIATELY TO AVOID OVER EXPANDING THE SCAFFOLD TO ENSURE ADEQUATE SCAFFOLD APPOSITION. THIS WILL REDUCE THE RISK OF CAUSING SCAFFOLD DAMAGE. IT IS UNKNOWN IF THE IFU DEVIATION CONTRIBUTED TO THE REPORTED DIFFICULTY. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS COULD NOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/18/2021" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09258", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201105", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201105", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201105", "brand_name": "ABSORB", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201105", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201105", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10793457", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "216655258", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "216655259", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 8. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS [VLSCT] AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD [BRS] IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". PER THE ARTICLE: THE PATIENT UNDERWENT IMPLANTATION OF TWO BIORESORBABLE SCAFFOLDS (BRS) (3.0/18 MM AND 3.5/12 MM) IN A LESION IN THE LCX ARTERY (LEFT CIRCUMFLEX). SIX-MONTH ANGIOGRAPHIC FOLLOW-UP DOCUMENTED A FAVORABLE RESULT. 1494 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI (ST ELEVATION MYOCARDIAL INFARCTION). CORONARY ANGIOGRAPHY SHOWED VLSCT WITH THROMBOTIC OCCLUSION OF THE BRS. FLOW WAS RESTORED AFTER BALLOON DILATATION AND IMPLANTATION OF A DES([DRUG ELUTING STENT). NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09274", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201105", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20180424", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201105", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201105", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201105", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "71 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201105", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10795434", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "216642731", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ESTIMATED EVENT DATE. ESTIMATED IMPLANT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "216642732", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 4. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD (VLSCT) THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD (BRS) IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". THE PATIENT UNDERWENT RIGHT CORONARY ARTERY (RCA) INTERVENTION WITH IMPLANTATION OF A 3.5/12 MM BIORESORBABLE SCAFFOLD (BRS). FOLLOW-UP ANGIOGRAPHY SHOWED GOOD RESULTS WITHOUT SIGNIFICANT RESTENOSIS. 478 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH STEMI (ST ELEVATION MYOCARDIAL INFARCTION). CORONARY ANGIOGRAPHY SHOWED VLSCT WITH THROMBOTIC OCCLUSION OF THE BRS IN THE PROXIMAL RCA. AFTER THROMBUS ASPIRATION AND BALLOON DILATATION, A DES (DRUG ELUTING STENT) WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09286", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20201105", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190517", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201105", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201105", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201105", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201105", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10796317", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "216644147", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATE IS ESTIMATED. IMPLANT DATE IS ESTIMATED. THE SCAFFOLD REMAINS IN THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED WALL APPOSITION, PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE REPORTED POTENTIAL ADVERSE EVENTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "216644148", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 6. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS [VLSCT] AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD [BRS] IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". FROM THE ARTICLE: THE PATIENT WAS TREATED WITH TWO 3.5/28 MM BRS FOR PRESENTATION WITH NSTEMI [NON ST ELEVATION MYOCARDIAL INFARCTION]. FOLLOW-UP ANGIOGRAPHY AT 15 MONTHS AFTER THE INDEX PCI [PERCUTANEOUS CORONARY INTERVENTION] SHOWED A SATISFACTORY RESULT. 866 DAYS AFTER THE INDEX PCI, THE PATIENT PRESENTED WITH STEMI CAUSED BY VLSCT. ST-SEGMENT ELEVATION RESOLVED AFTER ADMINISTRATION OF HEPARIN IN THE EMERGENCY DEPARTMENT. THERE WAS TIMI 3 FLOW BY CORONARY ANGIOGRAPHY. OCT [OPTICAL COHERENCE TOMOGRAPHY] SHOWED THROMBOTIC MATERIAL SURROUNDING MALAPPOSED STRUTS IN THE LUMEN OF THE DISTAL RCA [RIGHT CORONARY ARTERY] AT THE SITE OF A FOCAL SCAFFOLD DISCONTINUITY. A DES [DRUG ELUTING STENT] WAS IMPLANTED WITH A GOOD PROCEDURAL RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09283", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20201105", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190610", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201105", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201105", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201105", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis", "Stenosis" ] } ], "distributor_city": "", "date_report": "20201105", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10796357", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "217331338", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ESTIMATED DATES OF EVENT AND IMPLANT. THE SCAFFOLD REMAINS IN THE PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE REPORTED WALL APPOSITION, PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE REPORTED POTENTIAL ADVERSE EVENT OF MYOCARDIAL INFARCTION, STENOSIS AND THROMBOSIS ARE LISTED IN THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVSS), INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "217331339", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 7 IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS [VLSCT] AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD [BRS] IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". PER THE ARTICLE: THE PATIENT PRESENTED WITH NSTEMI [NON ST ELEVATION MYOCARDIAL INFARCTION] AND SUBTOTAL OCCLUSION OF THE PROXIMAL LAD [LEFT ANTERIOR DESCENDING CORONARY ARTERY]. A 3.5/18 MM BRS WAS IMPLANTED. SIX-MONTH FOLLOW-UP ANGIOGRAPHY SHOWED AN EXCELLENT RESULT IN THE PROXIMAL LAD. 890 DAYS AFTER BRS IMPLANTATION, THE PATIENT WAS ADMITTED TO HOSPITAL WITH STEMI. CORONARY ANGIOGRAPHY SHOWED VLSCT WITH SUBTOTAL THROMBOTIC OCCLUSION OF THE SCAFFOLD IN THE PROXIMAL LAD. OCT [OPTICAL COHERENCE TOMOGRAPHY] SHOWED A FOCAL AREA OF MILD TO MODERATE RESTENOSIS, A TISSUE BRIDGE POSSIBLY CONSEQUENT ON CHRONIC MALPOSITION AND FOCAL SCAFFOLD DISCONTINUITY WITH THROMBOSIS OVERLYING MALPOSED STRUTS IN THE VESSEL LUMEN. FLOW WAS RESTORED AFTER BALLOON DILATION AND DES [DRUG ELUTING STENT] IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-09296", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "951", "date_added": "20201106", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201106", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201106", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20201106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10801788", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "215069451", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED AND THE REPORTED DEATH CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE XIENCE AND XIENCE PRIME REFERENCED IN B5 ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT #S. ARTICLE TITLE: POLY (L-LACTIC ACID) BIORESORBABLE SCAFFOLDS VERSUS METALLIC DRUG-ELUTING STENTS FOR THE TREATMENT OF CORONARY ARTERY DISEASE: A META-ANALYSIS OF 11 RANDOMIZED TRIALS." }, { "mdr_text_key": "215069452", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE PRIME, AND XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 10,707 PATIENTS THAT WERE TREATED WITH XIENCE/XIENCE PRIME STENTS AND ABSORB SCAFFOLDS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"POLY (L-LACTIC ACID) BIORESORBABLE SCAFFOLDS VERSUS METALLIC DRUG-ELUTING STENTS FOR THE TREATMENT OF CORONARY ARTERY DISEASE: A META-ANALYSIS OF 11 RANDOMIZED TRIALS.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09298", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "951", "date_added": "20201106", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201106", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10801855", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "215069586", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATES ESTIMATED THE PATIENT DEATHS REFERENCED IN EVENT DESCRIPTION WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT #. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED AND THE REPORTED PATIENT EFFECTS CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE XIENCE AND XIENCE PRIME REFERENCED IN EVENT DESCRIPTION ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT #S. ARTICLE TITLE: POLY (L-LACTIC ACID) BIORESORBABLE SCAFFOLDS VERSUS METALLIC DRUG-ELUTING STENTS FOR THE TREATMENT OF CORONARY ARTERY DISEASE: A META-ANALYSIS OF 11 RANDOMIZED TRIALS." }, { "mdr_text_key": "215069587", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING ABSORB, XIENCE PRIME, AND XIENCE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATH, MYOCARDIAL INFARCTION, THROMBOSIS, REVASCULARIZATION, AND REHOSPITALIZATION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 10,707 PATIENTS THAT WERE TREATED WITH XIENCE/XIENCE PRIME STENTS AND ABSORB SCAFFOLDS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"POLY (L-LACTIC ACID) BIORESORBABLE SCAFFOLDS VERSUS METALLIC DRUG-ELUTING STENTS FOR THE TREATMENT OF CORONARY ARTERY DISEASE: A META-ANALYSIS OF 11 RANDOMIZED TRIALS.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09308", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20190201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201106", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201106", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aneurysm", "Myocardial Infarction", "Tachycardia", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10804448", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "215606984", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DATE OF EVENT HAS BEEN ESTIMATED. THE DATE OF IMPLANT HAS BEEN ESTIMATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. LITERATURE ATTACHMENT. ARTICLE TITLE: VERY LATE SCAFFOLD THROMBOSIS AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY. THE UDI NUMBER IS UNKNOWN AS THE PART AND LOT #S WERE NOT PROVIDED." }, { "mdr_text_key": "215606985", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PATIENT 9. IT WAS REPORTED THAT THIS PATIENT WAS FEATURED IN A JOURNAL ARTICLE TITLED, \"VERY LATE SCAFFOLD THROMBOSIS [VLSCT[ AFTER EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD [BRS] IMPLANTATION IN PATIENTS WITH UNREMARKABLE INTERIM SURVEILLANCE ANGIOGRAPHY\". THE PATIENT UNDERWENT IMPLANTATION OF A 3.5/28 MM BRS IN A LESION IN THE PROXIMAL LAD [LEFT ANTERIOR DESCENDING] IN THE SETTING OF STEMI [ST ELEVATION MYOCARDIAL INFARCTION]. SIX-MONTH ANGIOGRAPHIC FOLLOW-UP DOCUMENTED A FAVORABLE RESULT IN THIS LESION. 1440 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH NSTEMI [NON-ST ELEVATION MYOCARDIAL INFARCTION] AND RECURRENT NON-SUSTAINED VENTRICULAR TACHYCARDIA. CORONARY ANGIOGRAPHY WITH OCT [OPTICAL COHERENCE TOMOGRAPHY] IMAGING SHOWED VLSCT WITH THROMBOTIC MATERIAL AND FORMATION OF A LARGE ANEURYSM IN THE REGION OF THE IMPLANTED BRS. THE LESION WAS TREATED WITH DES [DRUG ELUTING STENT] IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-09309", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160927", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "951", "date_added": "20201106", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201106", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "1012462-28", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201211", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "62 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20201106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10804612", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "215251156", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF DEATH - ESTIMATED. DATE OF IMPLANT - ESTIMATED. THE SCAFFOLD REMAINS IMPLANTED IN THE PATIENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. LITERATURE ATTACHMENT. ARTICLE TITLE \u00bfONE-YEAR RESULTS FOLLOWING A PRE-SPECIFIED ABSORB IMPLANTATION STRATEGY IN ST-ELEVATION MYOCARDIAL INFARCTION ((B)(6) STUDY)\"." }, { "mdr_text_key": "215251157", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO THE FOLLOWING: AFTER PRE-DILATATION OF THE LESION IN THE LEFT CIRCUMFLEX TO OBTUSE MARGINAL (LCX-OM) CORONARY ARTERY, A 2.50X28MM ABSORB SCAFFOLD WAS IMPLANTED AND POST DILATED. TWENTY SIX DAYS AFTER SCAFFOLD IMPLANTATION, THE PATIENT DIED FROM CARDIAC DEATH. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ONE-YEAR RESULTS FOLLOWING A PRE-SPECIFIED ABSORB IMPLANTATION STRATEGY IN ST-ELEVATION MYOCARDIAL INFARCTION (BVS STEMI STRATEGY-IT STUDY)\". SPECIFICALLY, THIS EVENT CAPTURES CASE 3 FROM TABLE 3 IN THE ARTICLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Death", "report_number": "2024168-2020-09313", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201106", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201106", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20201211", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20201106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10805142", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "215250790", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF DEATH - ESTIMATED. DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT - ESTIMATED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY REMAIN IMPLANTED. A REVIEW OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORIES COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBERS WERE NOT PROVIDED. THE PATIENT EFFECT OF DEATH IS CONSISTENT WITH THE PRODUCT RISK PROFILE. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING THE OTHER ADVERSE EVENTS MENTIONED ARE FILED UNDER A SEPARATE MEDWATCH REPORT. ATTACHMENT: ARTICLE TITLE: IMPACT OF CORONARY CALCIFICATION ON OUTCOMES AFTER ABSORB SCAFFOLD IMPLANTATION: INSIGHTS FROM THE GABI-R REGISTRY." }, { "mdr_text_key": "215250791", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS IS FILED TO REPORT PATIENT DEATHS. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING: CARDIAC DEATH, TARGET LESION REVASCULARIZATION, TARGET VESSEL MYOCARDIAL INFARCTION, DEFINITE OR PROBABLE SCAFFOLD THROMBOSIS, MAJOR ADVERSE CARDIAC EVENTS, HEMORRHAGE, PERFORATION, RENAL FAILURE, STROKE AND PERCUTANEOUS CORONARY INTERVENTION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 3140 PATIENTS WITH 3790 LESIONS, TREATED WITH THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD. DETAILS ARE LISTED IN THE ARTICLE TITLED, \"IMPACT OF CORONARY CALCIFICATION ON OUTCOMES AFTER ABSORB SCAFFOLD IMPLANTATION: INSIGHTS FROM THE GABI-R REGISTRY\". PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09314", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20151101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "951", "date_added": "20201106", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201106", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK ABSORB", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "61 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stroke/CVA", "Hemorrhage/Blood Loss/Bleeding", "Myocardial Infarction", "Perforation", "Renal Failure", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20201106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10805161", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "215287398", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. DATE OF IMPLANT: ESTIMATED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY REMAIN IMPLANTED. A REVIEW OF THE LOT HISTORY RECORDS AND COMPLAINT HISTORIES COULD NOT BE CONDUCTED BECAUSE THE LOT AND PART NUMBERS WERE NOT PROVIDED. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ARTICLE TITLE: IMPACT OF CORONARY CALCIFICATION ON OUTCOMES AFTER ABSORB SCAFFOLD IMPLANTATION: INSIGHTS FROM THE GABI-R REGISTRY." }, { "mdr_text_key": "215287399", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS IS FILED TO REPORT THE SERIOUS INJURIES. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE SCAFFOLDS THAT MAY BE RELATED TO THE FOLLOWING: CARDIAC DEATH, TARGET LESION REVASCULARIZATION, TARGET VESSEL MYOCARDIAL INFARCTION, DEFINITE OR PROBABLE SCAFFOLD THROMBOSIS, MAJOR ADVERSE CARDIAC EVENTS, HEMORRHAGE, PERFORATION, RENAL FAILURE, STROKE AND PERCUTANEOUS CORONARY INTERVENTION. THIS ARTICLE SUMMARIZES CLINICAL OUTCOMES OF 3140 PATIENTS WITH 3790 LESIONS, TREATED WITH THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD. DETAILS ARE LISTED IN THE ARTICLE TITLED, \"IMPACT OF CORONARY CALCIFICATION ON OUTCOMES AFTER ABSORB SCAFFOLD IMPLANTATION: INSIGHTS FROM THE GABI-R REGISTRY\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "TEMECULA", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-09315", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20201106", "manufacturer_address_2": "", "pma_pmn_number": "P150023", "date_of_event": "20160904", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "925914628", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "951", "date_added": "20201106", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20201106", "brand_name": "ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM", "generic_name": "BIORESORBABLE SCAFFOLD", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "1012464-28", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "PNY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Absorbable Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210108", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4628", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20201106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction" ] } ], "distributor_city": "", "date_report": "20201106", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10805494", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20201021", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92591", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 2024168", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "215606639", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT ESTIMATED AS (B)(6) 2016. DATE OF IMPLANT ESTIMATED AS (B)(6) 2016. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. A CONCLUSIVE CAUSE FOR THE DIFFICULTIES LISTED CAN NOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING ATTACHMENT: ARTICLE: ONE-YEAR RESULTS FOLLOWING A PRE-SPECIFIED ABSORB IMPLANTATION STRATEGY IN ST-ELEVATION MYOCARDIAL INFARCTION (BVS STEMI STRATEGY-IT STUDY) . THE OTHER EVENTS REFERENCED IN THE ARTICLE ARE FILED UNDER OTHER MFR REPORT NUMBERS." }, { "mdr_text_key": "215606640", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) THAT MAY BE RELATED TO THE FOLLOWING: AFTER PRE-DILATATION OF THE LESION IN THE DISTAL RIGHT CORONARY ARTERY, A 3.5X28MM ABSORB SCAFFOLD WAS IMPLANTED AND POST DILATED. THREE DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION USING NC BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"ONE-YEAR RESULTS FOLLOWING A PRE-SPECIFIED ABSORB IMPLANTATION STRATEGY IN ST-ELEVATION MYOCARDIAL INFARCTION (BVS STEMI STRATEGY-IT STUDY)\". PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION. THIS EVENT CAPTURES CASE 2 UNDER TABLE 3." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "26531 YNEZ ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_contact_pcity": "09170809", "event_type": "Injury", "report_number": "9612164-2020-01684", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P100021", "date_of_event": "20200418", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "091708096", "noe_summarized": "1", "manufacturer_contact_l_name": "SWEENEY", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "091", "date_added": "20200427", "manufacturer_contact_f_name": "ALISON", "device_date_of_manufacturer": "20200130", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "ENDURANT II ILIAC STENT GRAFT", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220129", "model_number": "ETLW1610C124E", "catalog_number": "ETLW1610C124E", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00643169467644", "udi_public": "00643169467644", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/27/2020", "manufacturer_contact_country": "", "date_changed": "20210723", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "0917", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "78 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Occlusion", "Pain", "Weakness" ] } ], "distributor_city": "", "date_report": "20200525", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "GALWAY", "mdr_report_key": "10000147", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200419", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC IRELAND", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190502577", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "190502578", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 42MM ABDOMINAL AORTIC ANEURYSM. ONE DAY PREVIOUSLY THE PATIENT HAD A RIGHT FEMORAL ENDARTERECTOMY PERFORMED. THE EVAR PROCEDURE REPORTEDLY WENT WELL AND THE PATIENT WAS DISCHARGED THE NEXT DAY. POST-OPERATIVELY NINE DAYS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH LEG PAIN AND WEAKNESS. THE PATIENT HAD WEAK PULSES. A CT WAS PERFORMED WHICH SHOWED A LIMB OCCLUSION. THE IMAGES REVEALED THAT THE RIGHT ENDURANT LIMB IS SEVERELY COMPRESSED THROUGH THE DISTAL AORTA. IT WAS NOTED THE DISTAL AORTIC MEASURED ONLY 16 MM IN DIAMETER. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS THE RIGHT LIMB BEING COMPRESSED THROUGH THE DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED." }, { "mdr_text_key": "202425015", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE RIGHT FEMORAL ENDARTERECTOMY WAS PERFORMED DURING THE EVAR PROCEDURE AND NOT THE DAY PREVIOUSLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "PARKMORE BUSINESS PARK WEST", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "091", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "05/25/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2183870-2020-00126", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K132777", "date_of_event": "20200413", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER", "generic_name": "CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL", "manufacturer_d_name": "COVIDIEN", "manufacturer_d_address_1": "4600 NATHAN LANE NORTH", "manufacturer_d_address_2": "", "manufacturer_d_city": "PLYMOUTH", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55442", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55442", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20221219", "model_number": "AB14W060120150", "catalog_number": "AB14W060120150", "lot_number": "A951346", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200511", "device_report_product_code": "LIT", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00763000110482", "udi_public": "00763000110482", "openfda": { "device_name": "Catheter, Angioplasty, Peripheral, Transluminal", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2", "registration_number": [ "2183870" ], "fei_number": [ "2183870" ] } } ], "product_problems": [ "Burst Container or Vessel", "Deflation Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/27/2020;06/02/2020", "manufacturer_contact_country": "", "date_changed": "20230615", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "83 YR", "patient_sex": "", "patient_weight": "75", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200603", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000157", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190485865", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "190485866", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PHYSICIAN INTENDED TO USE A NANOCROSS ELITE DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT\u00bfS DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT A LONGITUDINAL BALLOON BURST OCCURRED DURING BALLOON INFLATION AT A PRESSURE OF 14ATM IN A VERY CALCIFIED SFA PTA BYPASS GRAFT. AS THE DEVICE WAS BEING REMOVED IT WAS SUSPECTED THE BALLOON COULD NOT FULLY DEFLATE. THE BALLOON WAS REPORTED TO BE STUCK ON THE WIRE SO A NON-MEDTRONIC DEVICE WAS ADVANCED OVER THE BALLOON. A NEEDLE WAS INSERTED TO THE BALLOON TO FULLY DEFLATE THE PROXIMAL PORTION. A GOOSENECK SNARE DEVICE WAS THEN ADVANCED TO REMOVE THE FRAGMENTED PORTIONS. ALL BALLOON FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT INJURY REPORTED." }, { "mdr_text_key": "316962009", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION: THE NANOCROSS ELITE CATHETER WAS RECEIVED IN THREE SEGMENTS: OUTER TUBING, INNER GUIDEWIRE LUMEN, AND BALLOON CHAMBER. AN AUDIT OF THE DEVICE\u00bfS COMPONENTS WAS CONDUCTED: THE Y-MANIFOLD AND THE PROXIMAL BALLOON RADIOPAQUE MARKER BAND WERE NOT RETURNED. THE DISTAL END OF THE OUTER TUBING CONTAINED THE BALLOON CHAMBER PROXIMAL BOND. THE BALLOON CHAMBER SEPARATION FACE EXHIBITS RADIAL /CIRCUMFERENTIAL TEARING. THE DISTAL END OF THE INNER GUIDEWIRE LUMEN EXHIBITS TENSILE STRETCHING/NECKING DOWN. NO RADIOPAQUE MARKER BAND WAS LOCATED ON THE INNER GUIDEWIRE LUMEN. THE BALLOON CHAMBER SEGMENT CONSISTS OF THE DISTAL TIP, DISTAL BALLOON BOND, MAJORITY OF THE BALLOON CHAMBER MATERIAL, AND APPROXIMATELY 64MM OF INNER GUIDEWIRE LUMEN ALONG WITH ONE RADIOPAQUE MARKER BAND. THE INNER GUIDEWIRE LUMEN EXHIBITS TENSILE STRETCHING/NECKING DOWN WHICH ALLOWS THE RADIOPAQUE MARKER BAND TO MOVE ALONG ITS LENGTH. TECHNICAL ANALYSIS OF THE RETURNED NANOCROSS ELITE DILATATION CATHETER CONFIRMED THE REPORTED EVENT OF BALLOON BURST, DILATATION CATHETER INTERACTION WITH GUIDEWIRE AND SHEATH WHICH RESULTED IN BALLOON CHAMBER EMBOLIZATION FROM THE CATHETER. IT IS NOTED THAT ONE OF THE RADIOPAQUE MARKER BANDS AND THE Y-MANIFOLD WERE NOTE RETURNED WITH THE DEVICE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "317219312", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: ALL COMPONENTS OF THE DEVICE WERE SAFELY REMOVED FROM THE PATIENT. THERE WAS NO VESSEL DAMAGE NOTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/29/2020;06/03/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9612164-2020-01685", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P100021", "date_of_event": "20200420", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "ENDURANT II BIFURCATED STENT GRAFT", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220120", "model_number": "ETBF2813C166EJ", "catalog_number": "ETBF2813C166EJ", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ] } } ], "product_problems": [ "Leak/Splash" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/25/2020", "manufacturer_contact_country": "", "date_changed": "20230620", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "85 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20200624", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000193", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200420", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190502812", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "190502813", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50 MM ABDOMINAL AORTIC ANEURYSM. THE ET BF2813C166EJ WAS IMPLANTED JUST BELOW THE LEFT RENAL ARTERY (RA). IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS CONFIRMED ON FINAL ANGIOGRAPHY. TOUCH-UP OF PROXIMAL NECK WAS PERFORMED AGAIN, BUT THE TYPE IA ENDOLEAK WA STILL PRESENT. INTERVENTION WAS PERFORMED AND AN AORTIC CUFF WAS IMPLANTED. THE ETCF2828C49EJ WAS IMPLANTED SO THE CUFF COVERED TO THE LEFT RENAL ARTERY (DUE TO THIS BEING A DIALYSIS PATIENT). FOLLOWING THIS, TOUCH-UP WAS PERFORMED AGAIN BUT ANOTHER ANGIOGRAPHY SHOWED THE TYPE IA ENDOLEAK STILL REMAINED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY. THE PROXIMAL NECK HAD A LARGE AREA OF CALCIFICATION AROUND THE FULL CIRCUMFERENCE, AND THE CALCIFICATION HINDERED THE SEALING OF THE NECK. NO ADDITIONAL CLINICAL SEQUALAE WERE PERFORMED AND THE PATIENT WILL BE MONITORED." }, { "mdr_text_key": "317493969", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED: IT WAS CONFIRMED THAT THE LEFT RENAL ARTERY WAS COVERED INTENTIONALLY WITH THE ENDURANT CUFF BECAUSE THE PATIENT WAS A DIALYSIS PATIENT. FURTHER TREATMENT OF A TYPE IA ENDOLEAK IS NOT PLANNED; THE ACTIVATED CLOTTING TIME (ACT) WAS LOWERED AND THE ENDOLEAK WAS EXPECTED TO RESOLVE BY POSTOPERATIVE THROMBOSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/23/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9612164-2020-01686", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P100040", "date_of_event": "20200416", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "VALIANT CAPTIVIA - CW", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210818", "model_number": "VAMC2828C100TJ", "catalog_number": "VAMC2828C100TJ", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ] } } ], "product_problems": [ "Leak/Splash" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/23/2020", "manufacturer_contact_country": "", "date_changed": "20230714", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "79 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection" ] } ], "distributor_city": "", "date_report": "20200702", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000282", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200423", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190502919", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "190502920", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 106MM TYPE B THORACIC DISSECTION. THE TWO ENTRIES IN THE DESCENDING AORTA WAS ABLE TO BE CLOSED AND NO BLOOD FLOW TO FALSE LUMEN WAS OBSERVED, THE PROCEDURE WAS THEN COMPLETED. DURING POSTOPERATIVE FOLLOW-UP, A CT SCAN PERFORMED A WEEK LATER SHOWED A RE-DISSECTION WAS OBSERVED AT THE DISTAL EDGE OF THE STENT GRAFT AND BLOOD FLOW TO THE FALSE LUMEN WAS ALSO OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS CONSIDERED POSSIBLY TO BE THAT THERE WAS CALCIFICATION AT THE DISTAL EDGE OF THE IMPLANTED STENT GRAFT, AND BY INTERFERING THERE, IT MIGHT HAVE APPLIED PRESSURE ON THE BLOOD VESSEL CREATING AN ENTRY THERE, OR A ANOTHER CAUSE GIVEN WAS THAT IT MIGHT HAVE POSSIBLY OCCURRED BECAUSE IT MIGHT HAVE BEEN A FRAGILE BLOOD VESSEL ORIGINALLY THAT DEVELOPED THE DISSECTION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED." }, { "mdr_text_key": "319068346", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/02/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "PARQUE INDUSTRIAL SALVARCAR", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "DR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CD. JUAREZ, CHIHUAHUA", "manufacturer_contact_address_1": "14201 NW 60TH AVE.", "manufacturer_contact_pcity": "78631362", "event_type": "Injury", "report_number": "9616099-2008-00345", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080214", "manufacturer_address_2": "", "pma_pmn_number": "NA", "date_of_event": "20080206", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33014", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7863136240", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL, MEDICAL DIRECTOR", "source_type": [ "Foreign", "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "BE", "manufacturer_contact_area_code": "786", "date_added": "20080225", "manufacturer_contact_f_name": "GAURANG", "device_date_of_manufacturer": "20071101", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080214", "brand_name": "CYPHER SIROLIMUS-ELUTING CORONARY STENT", "generic_name": "DRUG-ELUTING STENT (NIQ)", "manufacturer_d_name": "CORDIS DE MEXICO", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "CD. JUAREZ, CHIHUAHUA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "MX", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20080430", "model_number": "NA", "catalog_number": "CRB23300", "lot_number": "13306041", "other_id_number": "PART #: NA", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7863", "patient": [ { "patient_sequence_number": "1", "date_received": "20080214", "sequence_number_treatment": [ "ASPIRIN", " CLOPIDOGREL" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "81 YR", "patient_sex": "", "patient_weight": "79", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080208", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "MX", "manufacturer_contact_city": "MIAMI LAKES", "mdr_report_key": "1000030", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080208", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CORDIS DE MEXICO", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "793950", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CLINICAL REGISTRY REPORTED THAT A PT EXPERIENCED MYOCARDIAL INFARCTION AFTER A PERCUTANEOUS INTERVENTION TO TREAT A LESION IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE PT IS A FEMALE PT WITH A HISTORY OF HYPERTENSION. THE PT WAS ON ASA AND CLOPIDOGREL PRIOR TO THE PROCEDURE. OTHER MEDICATIONS INCLUDED STATINS, ACE INHIBITORS AND BETA-BLOCKERS. INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. PRE-PROCEDURE CREATININE KINASE WAS 2 ABOVE THE UPPER NORMAL LIMIT, TROPONIN LEVEL WAS NOT DONE. TWO 3.0X23MM CYPHER STENTS WERE IMPLANTED IN THE PROXIMAL TO THE MID LAD (OVER LAPPING ONE ANOTHER) TO TREAT A LESION DESCRIBED AS 3.0X30MM LONG, DE NOVO, IRREGULAR, ECCENTRIC WITH MODERATE CALCIFICATION, CLASSIFIED AS TYPE B2 WITH 80% STENOSIS. PRE DILATATION WAS CONDUCTED WITH AN UNK 3.0X30MM BALLOON. THE FIRST STENT WAS DEPLOYED AT 12 ATMS AND THE SECOND STENT WAS DEPLOYED AT 16 ATMS. EACH STENT WAS POST DILATED WITH AN UNK 3.5X20MM BALLOON AT 10 ATMS. THERE WAS A 10% RESIDUAL STENOSIS. A PROCEDURAL COMPLICATION OF A NON-Q-WAVE LATERAL WALL MYOCARDIAL INFARCTION WAS REPORTED. IT WAS ALSO REPORTED THAT THE SECOND DIAGONAL BRANCH SHOWED A TIMI FLOW OF 1 TO 2 AND THE PT ALSO HAD ANGINAL COMPLAINTS. THE PT WAS OBSERVED IN THE INTENSIVE CARE UNIT AND UNSPECIFIED BLOOD TEST WERE PERFORMED. THERE WAS NOT TREATMENT PT OUTCOME WAS ONGOING AND IMPROVED." }, { "mdr_text_key": "8094445", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CIRCUITO INTERIOR NORTE #1820", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33014", "manufacturer_contact_exchange": "786", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "DR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SAN GERMAN", "manufacturer_contact_address_1": "14201 NW 60 AVE", "manufacturer_contact_pcity": "78631362", "event_type": "Injury", "report_number": "3003742446-2008-00019", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080214", "manufacturer_address_2": "", "pma_pmn_number": "P020026", "date_of_event": "20050304", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33014", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7863136240", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL, MEDICAL DIRECTOR", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "00683", "manufacturer_g1_state": "PR", "reporter_country_code": "US", "manufacturer_contact_area_code": "786", "date_added": "20080225", "manufacturer_contact_f_name": "GUARANG", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080214", "brand_name": "CYPHER SIROLIMUS-ELUTING CORONARY STENT", "generic_name": "DRUG-ELUTING STENT (NIQ)", "manufacturer_d_name": "CORDIS LLC (PR)", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SAN GERMAN", "manufacturer_d_state": "PR", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NA", "catalog_number": "CYPHER", "lot_number": "UNK", "other_id_number": "PART #: NA", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7863", "patient": [ { "patient_sequence_number": "1", "date_received": "20080214", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "34 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080124", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MIAMI LAKES", "mdr_report_key": "1000032", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "00683", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CORDIS LLC (PR)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780199", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PT RECEIVED 3 CYPHER STENTS TO PORTIONS OF THE LEFT VENTRICLE APPROXIMATELY 4 1/2 YEARS AGO. APPROXIMATELY 7 MONTHS LATER, SHE HAD A PAINFUL HEART INJURY RESULTING FROM IN-STENT RESTENOSIS. ADD'L INFO IS NOT CURRENTLY AVAILABLE." }, { "mdr_text_key": "7934130", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PLEASE NOTE THAT THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVAL. THIS FEMALE PT EXPERIENCED RESTENOSIS APPROX. 7 MONTHS POST IMPLANTATION OF 3 CYPHER STENTS. PAST MEDICAL HISTORY IS UNK. THE INDICATION OF THE INDEX PROCEDURE WAS UNK. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN A LESION DESCRIBED BY THE REPORT TO BE LOCATED IN \"PORTIONS\" OF HER LEFT VENTRICLE\". DESCRIPTION OF THE VESSEL SUCH AS PERCENTAGE OF STENOSIS, TORTUOSITY, PRESENCE OF CALCIFICATION, ETC, WAS NOT REPORTED. VESSEL CLASSIFICATION WAS NOT REPORTED. THERE IS NO INFORMATION REGARDING PROCEDURAL DETAILS SUCH AS: DEBULKING OR PRE-DILATION OF LESION BEFORE STENTS DEPLOYMENT, PRE AND POST PROCEDURE CARDIAC ENZYME VALUES, OR PRE AND INTRA PROCEDURE MEDICATIONS USED. THREE CYPHER STENTS OF UNK LENGTH AND DIAMETER, UNK LOT NUMBER AND UNK EXPIRATION DATE, WERE DEPLOYED AT UNK PRESSURE IN AN UNIDENTIFIED SECTION OF THE HEART. POST DILATION OF STENTS WAS NOT REPORTED. THE REPORT DID NOT INDICATE IF THE STENTS WERE DEPLOYED IN AN OVERLAPPING MANNER. THE RESIDUAL DIAMETER STENOSIS WAS NOT REPORTED. TIMI FLOW WAS NOT REPORTED. THE REPORT DID NOT INDICATE WHEN THE PT WAS DISCHARGED FROM THE HOSPITAL NOR INDICATED WHAT MEDICATIONS WERE PRESCRIBED AT DISCHARGE EXCEPT FOR ANTIPLATELET THERAPY. SEVEN MONTHS LATER, THE REPORT EXPLAINED THAT THE PT EXPERIENCED RESTENOSIS. THERE WAS NO INFO ABOUT IN-STENT, PERI-STENT AND OR IN WHAT STENT/S RESTENOSIS WAS FOUND AS CONFIRMED BY CORONARY ANGIOGRAPHY. THERE WAS NO INFO ABOUT LAB VALUES OF EKG DONE. THERE WAS NO INFO ON HOW THE RESTENOSIS WAS TREATED. THE PRODUCTS REMAINED IMPLANTED IN THE PT AND ARE THUS NOT AVAILABLE FOR EVAL. A DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS OF THE PRODUCTS WERE NOT REPORTED. THE IFU WARNS THAT THE USE OF THIS DEVICE CARRIES THE ASSOCIATED RISKS OF SUB-ACUTE THROMBOSIS, VASCULAR COMPLICATION AND/OR BLEEDING EVENTS. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. PT WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS; HOWEVER, WITHOUT ADD'L INFO, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. WITH SUCH LIMITED PT AND PROCEDURAL INFO AVAILABLE FOR REVIEW, THE LACK OF PRODUCT'S LOT NUMBERS TO PERFORM DHR REVIEWS AND THE UNAVAILABILITY OF THE PRODUCTS TO ANALYZE, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "ROAD 362 KM 0.5", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33014", "manufacturer_contact_exchange": "786", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "PARQUE INDUSTRIAL SALVARCAR", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "DR", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CD. JUAREZ, CHIHUAHUA", "manufacturer_contact_address_1": "14201 NW 60 NW AVE", "manufacturer_contact_pcity": "78631362", "event_type": "Injury", "report_number": "9616099-2008-00341", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080214", "manufacturer_address_2": "", "pma_pmn_number": "NA", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33014", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7863136240", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL, MEDICAL DIRECTOR", "source_type": [ "Foreign", "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "TC", "manufacturer_contact_area_code": "786", "date_added": "20080225", "manufacturer_contact_f_name": "GUARANG", "device_date_of_manufacturer": "20070801", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080214", "brand_name": "CYPHER SIROLIMUS-ELUTING CORONARY STENT", "generic_name": "DRUG-ELUTING STENT (NIQ)", "manufacturer_d_name": "CORDIS DE MEXICO", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "JUAREZ, CHIHUAHUA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "MX", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20080131", "model_number": "NA", "catalog_number": "CRB18275", "lot_number": "13264119", "other_id_number": "PART #: NA", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7863", "patient": [ { "patient_sequence_number": "1", "date_received": "20080214", "sequence_number_treatment": [ "CLOPIDOGREL", " CLOPIDOGREL", " PRE-PROCEDURE MEDICATIONS INCLUDED:", " ASPIRIN", " ASPIRIN", " POST-ASPIRIN", " CLOPIDOGREL", " INTRA-PROCEDURE MEDICATION INCLUDED:" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "70", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080124", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "MX", "manufacturer_contact_city": "MIAMI LAKES", "mdr_report_key": "1000033", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CORDIS DE MEXICO", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "19326806", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS PT PRESENTED TO CARDIAC CATHERIZATION WITH ACUTE LATERAL ST EVALUATION MYOCARDIAL INFARCTION WITHIN 6 TO 12 HOURS OF INTERVENTION. THROMBOLYTIC AGENT WAS GIVEN. PRE-PROCEDURE CK AND CK-MB WERE 4 TIMES ABOVE THE UPPER NORMAL LIMITS. TROPONIN WAS 2 TIMES ABOVE THE UPPER NORMAL LIMITS. LEFT VENTRICLE EJECTION FRACTION (LVEF) WAS > 50%. 1 -VESSEL DISEASE WAS FOUND. BLOOD PRESSURE WAS 140/78 AND THE HEART RATE WAS 70. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. PCI WAS PERFORMED ON A 90% DE NOVO LESION IN THE 1ST DIAGONAL OF 18MM IN LENGTH IN A 2.75MM VESSEL DIAMETER WITH MODERATE TORTUOUSITY OF THE PROXIMAL SEGMENT. THE (B1) CONCENTRIC LESION WAS CHARACTERIZED WITH A SMOOTH CONTOUR, MODERATE CALCIFICATION AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 2.0X15MM BALLOON AT 12 ATMOSPHERES (ATM) BEFORE A 2.75X18MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 14ATM WITH SATISFACTORY RESULTS. THERE WAS NO POST-DILATATION. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THROMBIN INHIBITION IN MYOCARDIAL INFARCTION (TIMI) III FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT USED AT ANY TIME IN THE PROCEDURE. THERE WERE NO PROCEDURAL COMPLICATIONS. CK, CK-MB AND TROPONIN WERE WITHIN NORMAL LIMITS AT THE 6-24 HOUR INTERVAL POST-PROCEDURE AND ALSO AT THE 24 HOUR-DISCHARGE INTERVAL. ON THE FOLLOWING DAY, THE PT HAD SUB-ACUTE THROMBOSIS IN THE TARGET SITE WAS VERIFIED BY ECG. ONGOING MEDICATIONS AT THE TIME WERE ASPIRIN AND CLOPIDOGREL. THIS EVENT WAS CONSIDERED UNRELATED TO THE STUDY DEVICE AND TO THE INDEX PROCEDURE. IT WAS CONSIDERED A SERIOUS ADVERSE EVENT AND REQUIRED INPATIENT HOSPITALIZATION. THE EVENT WAS RESOLVED ON THE FOLLOWING DAY. ADD'L INFO HAS BEEN REQUESTED. PLEASE NOTE THAT THIS DEVICE (LOT NO. 13264119) IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. IT IS ALSO NOT AVAILABLE FOR TESTING AND EVAL. ADD'L INFO RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT." }, { "mdr_text_key": "19174643", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS REPORTED BY THE STUDY, WITHIN 24 HOURS OF PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PT EXPERIENCED SUBACUTE STENT THROMBOSIS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CIRCUITO INTERIOR NORTE #1820", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33014", "manufacturer_contact_exchange": "786", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "PARQUE INDUSTRIAL SALVARCAR", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "DR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CD. JUAREZ, CHIHUAHUA", "manufacturer_contact_address_1": "14201 NW 60 AVE", "manufacturer_contact_pcity": "78631362", "event_type": "Injury", "report_number": "9616099-2008-00340", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080214", "manufacturer_address_2": "", "pma_pmn_number": "NA", "date_of_event": "20080116", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33014", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7863136240", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL, MEDICAL DIRECTOR", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "786", "date_added": "20080225", "manufacturer_contact_f_name": "GAURANG", "device_date_of_manufacturer": "20071001", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080214", "brand_name": "CYPHER SIROLIMUS-ELUTING CORONARY STENT", "generic_name": "DRUG-ELUTING STENT (NIQ)", "manufacturer_d_name": "CORDIS DE MEXICO", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "JUAREZ, CHIHUAHUA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "MX", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20080122", "model_number": "NA", "catalog_number": "CJS13300", "lot_number": "13299438", "other_id_number": "PART #: NA", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20080204", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7863", "patient": [ { "patient_sequence_number": "1", "date_received": "20080214", "sequence_number_treatment": [ "ENCORE26 INFLATION DEVICE", " RADIFOCUS SHEATH INTRODUCER", " RENATO/GET'S ROUTE GUIDE WIRE", " 3.0MM RYUJIN BALLOON CATHETER", " XB 3.5 BRITE TIP GUIDING CATHETER" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "UNK YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080121", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "MX", "manufacturer_contact_city": "MIAMI LAKES", "mdr_report_key": "1000034", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080121", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CORDIS DE MEXICO", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "793951", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH UNSTABLE ANGINA PECTORIS. THE PT HAD A LESION IN THE MID LEFT ANTERIOR DESCENDING BRANCH. THE LESION WAS DE NOVO, HIGHLY CALCIFIED AND MODERATELY TORTUOUS WITH 90% STENOSIS. THE LESION WAS PRE-DILATED WITH A BALLOON, THEN A 3.0X13MM CYPHER STENT WAS DELIVERED TO THE LESION AND INFLATED AT 12ATM WITHOUT A PROBLEM. AN INTRA VASCULAR ULTRA SOUND WAS CONDUCTED AND THE PHYSICIAN FOUND THAT THE STENT WAS UNDER DILATED. THEREFORE, THE STENT DELIVERY SYSTEM WAS DELIVERED TO THE LESION AGAIN FOR POST-DILATION. THE STENT DELIVERY SYSTEM WAS INFLATED TO 16ATM AND THE BALLOON SUDDENLY RUPTURED. A DIFFERENT HIGH-PRESSURE BALLOON WAS USED AND INFLATED TO 16ATM. THE PROCEDURE WAS SAFELY COMPLETED." }, { "mdr_text_key": "8094446", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CIRCUITO INTERIOR NORTE #1820", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33014", "manufacturer_contact_exchange": "786", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "PARQUE INDUSTRIAL SALVARCAR", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "DR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CD. JUAREZ, CHIHUAHUA", "manufacturer_contact_address_1": "14201 NW 60 AVE.", "manufacturer_contact_pcity": "78631362", "event_type": "Injury", "report_number": "9616099-2008-00347", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080214", "manufacturer_address_2": "", "pma_pmn_number": "P020036", "date_of_event": "20080130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33014", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7863136240", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL, MEDICAL DIRECTOR", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "786", "date_added": "20080225", "manufacturer_contact_f_name": "GAURANG", "device_date_of_manufacturer": "20071201", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080214", "brand_name": "SMART CONTROL NITINOL STENT SYSTEM", "generic_name": "SELF EXPANDING STENTS (NIO)", "manufacturer_d_name": "CORDIS DE MEXICO", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "JUAREZ, CHIHUAHUA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "MX", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20091031", "model_number": "NA", "catalog_number": "C06100ML", "lot_number": "13320090", "other_id_number": "PART #: NA", "device_availability": "No", "device_report_product_code": "NIO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "9616099" ], "fei_number": [ "3003528016" ], "device_name": "Stent, Iliac", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7863", "patient": [ { "patient_sequence_number": "1", "date_received": "20080214", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "UNK YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080130", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "MX", "manufacturer_contact_city": "MIAMI LAKES", "mdr_report_key": "1000036", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080130", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CORDIS DE MEXICO", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15604223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE SMART CONTROL (C06100ML) INTO THE PT'S SUPERFICIAL FEMORAL ARTERY, THE STENT DID NOT FULLY DEPLOY. THE PHYSICIAN HAD TO BREAK THE SMART CONTROL HANDLE AND PULL THE SHEATH BACK IN ORDER TO DEPLOY THE STENT. THE STENT WAS DEPLOYED APPROPRIATELY PER FLUOROSCOPY REPORT. THE PT WAS ASYMPTOMATIC UPON THE PARTIAL DEPLOYMENT AND WAS IN NO DISTRESS. THERE WERE ADVERSE CONSEQUENCE TO FEMALE PT." }, { "mdr_text_key": "15887481", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CIRCUITO INTERIOR NORTE #1820", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33014", "manufacturer_contact_exchange": "786", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "DR.", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MIAMI LAKES", "manufacturer_contact_address_1": "14201 N.W. 60TH AVE.", "manufacturer_contact_pcity": "78631362", "event_type": "Injury", "report_number": "1016427-2008-00037", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080214", "manufacturer_address_2": "", "pma_pmn_number": "P900043", "date_of_event": "20021007", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33014", "reporter_occupation_code": "PATIENT", "manufacturer_contact_plocal": "7863136240", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL", "source_type": [ "Consumer", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33014", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "786", "date_added": "20080225", "manufacturer_contact_f_name": "GAURANG", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080214", "brand_name": "BX VELOCITY BILIARY SDS", "generic_name": "CORONARY SDS/STENTS (MAF)", "manufacturer_d_name": "CORDIS CORPORATION", "manufacturer_d_address_1": ".", "manufacturer_d_address_2": "", "manufacturer_d_city": "MIAMI LAKES", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33014", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33014", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NA", "catalog_number": "VWH13250", "lot_number": "UNK", "other_id_number": "PART #: NA", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7863", "patient": [ { "patient_sequence_number": "1", "date_received": "20080214", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "108", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080118", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MIAMI LAKES", "mdr_report_key": "1000037", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080118", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "33014", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CORDIS CORPORATION", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15589803", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE BX VELOCITY STENT (COMPLAINT PRODUCT) WAS IMPLANTED DURING THE INDEX PROCEDURE TO TREAT RIGHT CORONARY ARTERY (RCA) TARGET LESION. THE PT REPORTED, HE PREVIOUSLY HAD A GUIDANT STENT IMPLANTED IN THIS VESSEL. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT." }, { "mdr_text_key": "15188086", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A REPORT RECEIVED FROM THE PT THROUGH THE MEDICAL AFFAIRS DEPARTMENT INDICATED THAT APPROX TWO MONTHS AFTER IMPLANTATION OF A BX VELOCITY 2.5X 13MM STENT WITH HEPACOAT, THE PT HAD CHEST PAIN. THE PT WAS ADMITTED EMERGENTLY TO THE HOSPITAL. CORONARY ANGIOGRAPHY REVEALED A 75% STENOSIS OF THE PREVIOUSLY IMPLANTED STENT. THE RESTENOSIS WAS TREATED NINETEEN DAYS LATER BY IMPLANTATION OF A GUIDANT STENT. ADD'L INFO HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "14201 N.W. 60TH AVE.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33014", "manufacturer_contact_exchange": "786", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-05626", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20191128", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "DISTRI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "PROMUS ELEMENT LONG", "generic_name": "STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200325", "model_number": "9315", "catalog_number": "9315", "lot_number": "0022752629", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200526", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/23/2020", "manufacturer_contact_country": "", "date_changed": "20230614", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "GUIDE CATHETER: EBU 3", " GUIDE CATHETER: EBU 3", " GUIDEWIRE: RUNTHROUGH", " GUIDEWIRE: RUNTHROUGH", " GUIDE CATHETER: EBU 3", " GUIDEWIRE: RUNTHROUGH" ], "sequence_number_outcome": [ "" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200624", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000508", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200416", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189032748", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "189032749", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED, 3X34MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION CONTAINED >45 AND <90 DEGREE BEND. AFTER A 6F NON-BSC GUIDE CATHETER AND A NON-BSC GUIDEWIRE WERE CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH A 2X12MM MAVERICK BALLOON CATHETER, LEAVING 40% RESIDUAL STENOSIS IN THE LESION. A 3.00X38MM PROMUS ELEMENT DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT HAD DIFFICULTY TRACKING THE STENT THROUGH THE LESION. AFTER REMOVAL, STRUT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE." }, { "mdr_text_key": "317131374", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: PROMUS ELEMENT,MR,OUS 3.00 X 38 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. AN EXAMINATION (VISUAL AND VIA SCOPE) OF THE CRIMPED STENT FOUND STENT DAMAGE. STENT STRUTS FROM THE PROXIMAL REGION OF THE STENT WERE NOTED TO BE LIFTED FROM THEIR CRIMPED POSITION AND PULLED PROXIMALLY. THE UNDAMAGED CRIMPED STENT OUTER DIAMETER WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND A KINK ALONG THE LENGTH OF THE HYPOTUBE SHAFT MEASURED AT 93.3 CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND A KINK IN THE SHAFT POLYMER EXTRUSION MEASURED AT 22.6CM PROXIMAL FROM THE DISTAL END OF THE TIP. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "317131375", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED, 3X34MM, CONCENTRIC, DE NOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION CONTAINED >45 AND <90 DEGREE BEND. AFTER A 6F NON-BSC GUIDE CATHETER AND A NON-BSC GUIDEWIRE WERE CROSSED THE LESION, PRE-DILATION WAS PERFORMED WITH A 2X12MM MAVERICK BALLOON CATHETER, LEAVING 40% RESIDUAL STENOSIS IN THE LESION. A 3.00X38MM PROMUS ELEMENT DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT HAD DIFFICULTY TRACKING THE STENT THROUGH THE LESION. AFTER REMOVAL, STRUT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/24/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-04870", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P150003", "date_of_event": "20200401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "SYNERGY", "generic_name": "BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211119", "model_number": "10601", "catalog_number": "10601", "lot_number": "0024854780", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200706", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729840039", "udi_public": "08714729840039", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/28/2020", "manufacturer_contact_country": "", "date_changed": "20230725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200819", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000690", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189033874", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT: USED (B)(6) 2020 AS THE CORRECT DATE WAS NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "189033875", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." }, { "mdr_text_key": "319686272", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B3 - DATE OF EVENT: USED (B)(6) 2020 AS THE CORRECT DATE WAS NOT PROVIDED. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II US MR 2.50 X 12 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND NO ISSUES. THERE WAS NO SIGN OF DAMAGE, STRETCHING OR LIFTING OF THE STENT STRUTS. THE STENT SHOWED NO SIGNS OF MOVEMENT AND WAS SET BETWEEN THE PROXIMAL AND DISTAL MARKER BANDS. THE CRIMPED STENT OD (OUTER DIAMETER) WAS MEASURED USING AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND MULTIPLE KINKS AND A BREAK 23.5CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. A VISUAL EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "319686273", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/19/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "MW1011544", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "19970624", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "19970601", "reprocessed_and_reused_flag": "", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "RISK MANAGER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "19970625", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "98526", "implant_flag": "N", "date_removed_flag": "*", "device_sequence_number": "1", "date_received": "19970624", "brand_name": "HI-TORQUE FLOPPY II", "generic_name": "GUIDEWIRE/MICROGLIDE COATING", "manufacturer_d_name": "GUIDANT ADVANCED CARDIOVASCULAR SYSTEM", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "model_number": "*", "catalog_number": "*", "lot_number": "7033151", "other_id_number": "REF 22359M-901", "device_operator": "HEALTH PROFESSIONAL", "device_availability": "Yes", "device_report_product_code": "DQX", "device_age_text": "", "device_evaluated_by_manufacturer": "", "baseline_510_k__flag": "", "baseline_510_k__number": "", "baseline_510_k__exempt_flag": "", "openfda": { "device_name": "Wire, Guide, Catheter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1330", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "", "date_changed": "19970625", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "19970624", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "64 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "19970617", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "100007", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "62032", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING ANGIOPLASTY/STENT PROCEDURE THE TIP OF THE WIRE (RADIO-OPAQUE #1) BROKE OFF IN THE LEFT CIRCUMFLEX CORONARY ARTERY, DISTAL END. VISUAL UNDER FLUOROSCOPY. NO RETRIEVAL ATTEMPT WAS MADE. PT STABLE. PROCEDURE WAS SUCCESSFULLY COMPLETED. RADIO-OPAQUE TIP IS 2 CM LONG." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03919", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20171212", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2024168" ], "fei_number": [ "2024168" ], "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000748", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189074934", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189074935", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH ANGINA. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X12MM BALLOON AT 10 ATMOSPHERES (ATMS), AND THE 3X18MM XIENCE STENT WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MYOCARDIAL INFARCTION (MI) 1472 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "318831784", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MAPLE GROVE", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-05597", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200421", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "DISTRI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "55311", "manufacturer_g1_state": "MN", "reporter_country_code": "CH", "manufacturer_contact_area_code": "763", "date_added": "20200427", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20181105", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "EXPRESS VASCULAR SD", "generic_name": "CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211104", "model_number": "20201", "catalog_number": "20201", "lot_number": "0022889700", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FGE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "product_problems": [ "Activation Failure" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200608", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "72", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10000782", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200421", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "55311", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189035596", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THERE WAS INADEQUATE APPOSITION. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 4.0MMX15MMX150CMEXPRESS VASCULAR SD STENT WAS ADVANCED FOR TREATMENT. THE DEVICE REACHED THE LESION. HOWEVER, THE BALLOON WHICH WAS INSIDE THE STENT COULD NOT APPOSE THE STENT. THE DEVICE WAS RETRIEVED WITHOUT ANY ADDITIONAL INTERVENTION PERFORMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "TWO SCIMED PLACE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SPENCER", "manufacturer_contact_address_1": "300 BOSTON SCIENTIFIC WAY", "manufacturer_contact_pcity": "50868340", "event_type": "Malfunction", "report_number": "3005099803-2020-01761", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K133700", "date_of_event": "20200207", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "01752", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5086834015", "noe_summarized": "1", "manufacturer_contact_l_name": "MORLEY", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "47460", "manufacturer_g1_state": "IN", "reporter_country_code": "KS", "manufacturer_contact_area_code": "508", "date_added": "20200427", "manufacturer_contact_f_name": "CAROLE", "device_date_of_manufacturer": "20190626", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "ADVANIX PANCREATIC STENT", "generic_name": "CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "300 BOSTON SCIENTIFIC WAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "MARLBOROUGH", "manufacturer_d_state": "MA", "manufacturer_d_zip_code": "01752", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "01752", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20201222", "model_number": "M00537290", "catalog_number": "3729", "lot_number": "0024014290", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200303", "device_report_product_code": "FGE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729856887", "udi_public": "08714729856887", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2", "registration_number": [ "3005099803" ], "fei_number": [ "3005099803" ] } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200428", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5086", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "53 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MARLBOROUGH", "mdr_report_key": "10000784", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200401", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "47460", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191673707", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE RETURNED ADVANIX PANCREATIC STENT WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE STENT WAS BENT IN THE MIDDLE AND THE PIGTAIL WAS KINKED. A FUNCTIONAL EVALUATION NOTED THAT THE FINDINGS FROM VISUAL ASSESSMENT INDICATE THAT LIKELY THERE WERE ISSUES ADVANCING THE DEVICE. NO OTHER ISSUES WITH THE DEVICE WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. THE ISSUE OCCURRED DURING PROCEDURE AND THE PATIENT PRESENTED STRICTURE, IT IS MOST LIKELY THAT PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING PROCEDURE COULD HAVE AFFECTED THE DEVICE PERFORMANCE AND ITS INTEGRITY. PATIENT ANATOMY CAN CAUSE ISSUES TO ADVANCE THE DEVICE TO THE INTENDED LOCATION, FORCE APPLIED TO THE DEVICE IN ORDER TO ADVANCE IT AND CUSTOMER MANEUVERING DURING PLACEMENT CAN LEAD TO BEND/KINK THE STENT, THIS CONDITION COULD HAVE AFFECTED THE OVERALL PERFORMANCE OF THE DEVICE. THEREFORE, \"ADVERSE EVENT RELATED TO PATIENT CONDITION\" IS SELECTED AS THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING." }, { "mdr_text_key": "191673708", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT COULD NOT PASS THROUGH THE STRICTURE SITE OF THE ANATOMY. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF PANCREATIC STENT BENT/KINKED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "780 BROOKSIDE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "01752", "manufacturer_contact_exchange": "508", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "TWO SCIMED PLACE", "manufacturer_contact_pcity": "76349425", "event_type": "Malfunction", "report_number": "2134265-2020-04914", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200202", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7634942574", "noe_summarized": "1", "manufacturer_contact_l_name": "JOHNSON", "source_type": [ "COMPANY REPRESENTATIVE", "DISTRI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "IN", "manufacturer_contact_area_code": "763", "date_added": "20200427", "manufacturer_contact_f_name": "JAY", "device_date_of_manufacturer": "20190528", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "PROMUS PREMIER SELECT", "generic_name": "STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210527", "model_number": "10663", "catalog_number": "10663", "lot_number": "0023896850", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200310", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "product_problems": [ "Failure to Advance" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200605", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7634", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "10000850", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189040453", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: P SELECT OUS MR 16 X 4.00MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS ON PROXIMAL REGION OF THE STENT WERE NOTED TO BE LIFTED AND PULLED IN A DISTAL DIRECTION. THE UNDAMAGED STENT OD (OUTER DIAMETER) WAS MEASURED AND THE RESULT IS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "189040454", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-APR-2020. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 16 X 4.00 PROMUS PREMIER SELECT DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT FAILED TO CROSS THE LESION EVEN AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55311", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9612164-2020-01689", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P100021", "date_of_event": "20190305", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "ENDURANT II AUI STENT GRAFT", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210204", "model_number": "ETUF2314C102E", "catalog_number": "ETUF2314C102E", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00643169232556", "udi_public": "00643169232556", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ] } } ], "product_problems": [ "Leak/Splash" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/30/2020;06/23/2020", "manufacturer_contact_country": "", "date_changed": "20230714", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "82 YR", "patient_sex": "", "patient_weight": "46", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20200702", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000857", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190503307", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "190503308", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ENDURANT II AUI STENT GRAFT WAS IMPLANTED ALONG WITH AN ENDURANT LIMB AND A NON-MDT CHIMNEY GRAFT IN THE ENDOVASCULAR TREATMENT OF A MAXIMUM DIAMETER 59.6MM ABDOMINAL AORTIC ANEURYSM. THERE WAS NOTED TO BE SEVERE PROXIMAL NECK TORTUOSITY WITH LOCALIZED THROMBUS AND CALCIUM AT THE PROXIMAL SEAL ZONE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE 6 ENDOANCHORS WERE IMPLANTED TO THE PROXIMAL NECK DUE TO AN OBSERVED TYPE IA ENDOLEAK. THIS SUCCESSFULLY RESOLVED THE ENDOLEAK. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE." }, { "mdr_text_key": "317356240", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B:5 ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE CAUSE OF THE INTRA-OPERATIVE TYPE IA ENDOLEAK WAS LIKELY CAUSED BY THE SNORKEL PLACED IN THE RENAL ARTERY (AND GUTTER LEAKS ARE LIKELY), AND ALSO THERE WAS A HIGHLY ANGULATED NECK. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A JUXTARENAL AAA. IT WAS REPORTED THAT DURING THE PROCEDURE 4 ENDOANCHORS WERE INITIALLY PLACED TO TREAT THE TYPE IA, BUT THE ENDOLEAK PERSISTED SO ANOTHER TWO ENDOANCHORS WERE IMPLANTED. AT THIS POINT IT WAS THOUGHT THAT THERE WAS A TYPE IV ENDOLEAK PRESENT DUE TO HEPARIN, NOTHING WAS DONE TO TREAT THIS ENDOLEAK. A CT SCAN PERFORMED OVER A MONTH LATER, SHOWED A POSSIBLE TYPE II ENDOLEAK ORIGINATING FROM THE LUMBER ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "319068745", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/26/2020;07/02/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2183870-2020-00127", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K032580", "date_of_event": "20200422", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD", "generic_name": "CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "COVIDIEN", "manufacturer_d_address_1": "4600 NATHAN LANE NORTH", "manufacturer_d_address_2": "", "manufacturer_d_city": "PLYMOUTH", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55442", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55442", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200523", "model_number": "SERP65-10-80-80", "catalog_number": "SERP65-10-80-80", "lot_number": "A464991", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200520", "device_report_product_code": "FGE", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2", "registration_number": [ "2183870" ], "fei_number": [ "2183870" ] } } ], "product_problems": [ "Malposition of Device" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/03/2020;06/03/2020", "manufacturer_contact_country": "", "date_changed": "20230630", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200605", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000959", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200423", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "195419366", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "195419367", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE GPS SELF EXPANDING STENT DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE COMMON ILIAC ARTERY. THE PRODUCT WAS TESTED PRIOR TO USE. IT WAS REPORTED THAT THE PHYSICIAN USED THE DEVICE PER IFU. IT IS UNKNOWN IS THE VESSEL WAS PRE-DILATED. IT IS UNKNOWN IF RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DELIVERY SYSTEM. PHYSICIAN DEPLOYED THE STENT BUT IT JUMPED. THE STENT DID NOT ELONGATE OR SHORTEN DURING THE PROCEDURE. IT IS UNKNOWN IF THE DELIVERY CATHETER CAUGHT ON THE STENT UPON DEVICE WITHDRAWAL. ANOTHER PROT\u00c9G\u00c9 GPS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. PATIENTS IN A STABLE CONDITION." }, { "mdr_text_key": "318180292", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "318180390", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PRODUCT ANALYSIS: THE PROT\u00c9G\u00c9 GPS WAS RETURNED TO MEDTRONIC INVESTIGATION LAB. NO ANCILLARY DEVICES WERE INCLUDED. THE PROT\u00c9G\u00c9 GPS WAS RETURNED WITHOUT A STENT LOADED. THE DEPLOYMENT SYSTEM SHOWED THE TIP ASSEMBLY WAS PULLED INTO THE CATHETER SHAFT. THE HYPOTUBE WAS PULLED OUT FROM THE PROXIMAL DEPLOYMENT GRIP. THE TIP ASSEMBLY WAS PULLED INTO THE CATHETER SHAFT AND WAS LOCATED AT APPROXIMATELY 32 CM FROM THE DISTAL TIP OF THE CATHETER SHAFT. THE CLEAR INNER ASSEMBLY WAS EXPOSED AND STRETCHED OUT APPROXIMATELY. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/04/2020;06/05/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-04875", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200403", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "PROMUS ELITE", "generic_name": "CORONARY DRUG-ELUTING STENT", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "model_number": "UNK", "catalog_number": "UNK", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "product_problems": [ "Break", "Migration" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/07/2020", "manufacturer_contact_country": "", "date_changed": "20230628", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200602", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000969", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200403", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189038893", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "189038894", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT COATING ISSUE AND SHAFT BREAK WERE ENCOUNTERED. A 24 X 3.00 PROMUS ELITE DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, WHEN THE STENT WAS PULLED TO GO BACK WITH A BALLOON FOR PRE-DILATATION, THE COATING ON THE WIRE IN BETWEEN THE BALLOON AND THE EXIT FOR THE WIRE WERE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED." }, { "mdr_text_key": "317643612", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE IS A COMBINATION PRODUCT." }, { "mdr_text_key": "317643613", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT COATING ISSUE AND SHAFT BREAK WERE ENCOUNTERED. A 24 X 3.00 PROMUS ELITE DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, WHEN THE STENT WAS PULLED TO GO BACK WITH A BALLOON FOR PRE-DILATATION, THE COATING ON THE WIRE IN BETWEEN THE BALLOON AND THE EXIT FOR THE WIRE WERE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED. IT WAS FURTHER REPORTED THAT THE VESSEL WAS HEAVILY CALCIFIED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/02/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SPENCER", "manufacturer_contact_address_1": "300 BOSTON SCIENTIFIC WAY", "manufacturer_contact_pcity": "50868340", "event_type": "Malfunction", "report_number": "3005099803-2020-01762", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K133700", "date_of_event": "20200401", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "01752", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5086834015", "noe_summarized": "1", "manufacturer_contact_l_name": "MORLEY", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "47460", "manufacturer_g1_state": "IN", "reporter_country_code": "US", "manufacturer_contact_area_code": "508", "date_added": "20200427", "manufacturer_contact_f_name": "CAROLE", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "ADVANIX PANCREATIC STENT", "generic_name": "CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "300 BOSTON SCIENTIFIC WAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "MARLBOROUGH", "manufacturer_d_state": "MA", "manufacturer_d_zip_code": "01752", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "01752", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FGE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2" } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200428", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5086", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MARLBOROUGH", "mdr_report_key": "10001015", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200401", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "47460", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191672933", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT WAS APPROXIMATED TO 04/01/2019 AS NO EVENT DATE WAS REPORTED. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED." }, { "mdr_text_key": "191672934", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREOTOGRAPHY (ERCP) PROCEDURE. THE EXACT EVENT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PANCREATIC STENT WAS KINKED IN THE PROCESS ON DEPLOYING THE STENT. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "780 BROOKSIDE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "01752", "manufacturer_contact_exchange": "508", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SPENCER", "manufacturer_contact_address_1": "300 BOSTON SCIENTIFIC WAY", "manufacturer_contact_pcity": "50868340", "event_type": "Malfunction", "report_number": "3005099803-2020-01764", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K133700", "date_of_event": "20200401", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "01752", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "5086834015", "noe_summarized": "1", "manufacturer_contact_l_name": "MORLEY", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "47460", "manufacturer_g1_state": "IN", "reporter_country_code": "US", "manufacturer_contact_area_code": "508", "date_added": "20200427", "manufacturer_contact_f_name": "CAROLE", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "NAVIFLEX RX PUSHER", "generic_name": "CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "300 BOSTON SCIENTIFIC WAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "MARLBOROUGH", "manufacturer_d_state": "MA", "manufacturer_d_zip_code": "01752", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "01752", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FGE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2", "registration_number": [ "3005099803" ], "fei_number": [ "3005099803" ] } } ], "product_problems": [ "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200428", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5086", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MARLBOROUGH", "mdr_report_key": "10001091", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200401", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "47460", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "191671817", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2019 AS NO EVENT DATE WAS REPORTED. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED." }, { "mdr_text_key": "191671818", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREOTOGRAPHY (ERCP) PROCEDURE. THE EXACT EVENT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PANCREATIC STENT WAS KINKED IN THE PROCESS ON DEPLOYING THE STENT. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "780 BROOKSIDE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "01752", "manufacturer_contact_exchange": "508", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "OTHER", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191422", "event_type": "Injury", "report_number": "3004742046-2008-00039", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P040012", "date_of_event": "20080124", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519142200", "noe_summarized": "1", "manufacturer_contact_l_name": "REILLY", "source_type": [ "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "951", "date_added": "20080222", "manufacturer_contact_f_name": "KATHLEEN", "device_date_of_manufacturer": "20071201", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "RX ACCULINK CAROTID STENT SYSTEM", "generic_name": "", "manufacturer_d_name": "ABBOTT VASCULAR-VASCULAR SOLUTIONS", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "462", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92591 4628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20091130", "model_number": "NA", "catalog_number": "1011344-40", "lot_number": "7120351", "other_id_number": "NA", "device_availability": "No", "device_report_product_code": "NIM", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Carotid", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "RX ACCUNET", " BIVALIRUDIN" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "108", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080125", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "1000124", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080125", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "14868157", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "STUDY EVENT. DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: HYPOTENSION. TIME OF SYMPTOMS/AE: POST THE PROCEDURE. IT WAS REPORTED THAT POST RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE THE PT EXPERIENCED HYPOTENSION TREATED WITH UNSPECIFIED VASOPRESSORS AND A STAY IN THE CRITICAL CARE UNIT. REPORTEDLY, THE CONDITION RESOLVED IN 2008 AND THE PT WAS DISCHARGED TO HOME. NO ADD'L INFO WAS AVAILABLE." }, { "mdr_text_key": "15167914", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE STENT REMAINS IN THE PT, THE STENT DELIVERY SYSTEM WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MIAMI", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00455", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "K923480", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33166 6202", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "LUGE", "generic_name": "DQX WIRE, GUIDE, CATHETER", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MIAMI", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080205", "device_report_product_code": "DQX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ], "device_name": "Wire, Guide, Catheter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1330", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "620", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "4MM MICRO-SNARE KIT", " 8FR PINNACLE SHEATH", " 2MM MICRO-SNARE KIT", " 3.5MM X 9MM DRIVER OTW", " 5FR PINNACLE SHEATH", " 8FR JR 4.0 SH LAUNCHER", " 6FR PINNACLE SHEATH", " 4FR GOOSE NECK SNARE 5MM", " 3.5MM X 12MM TAXUS STENT", " 8FR FL 3.5 SH LAUNCHER", " 6FR JL 4.0" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000125", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "33166", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "18222349", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS MFR REPORT# 2134265-2008-00452. SAME CASE AS MFR REPORT# 2134265-2008-00453. SAME CASE AS MFR REPORT# 2134265-2008-00454. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE SEPARATION OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PERCENT OF THE STENOSIS, DEGREE OF CALCIFICATION, AND VESSEL TORTUOUSITY ARE UNK. A 300CM LUGE GUIDE WIRE WAS ADVANCED TO THE LESION AND AN UNSPECIFIED 3.5MM X 12MM STENT WAS IMPLANTED IN THE LAD. A SECOND 300CM LUGE GUIDE WIRE WAS ADVANCED, HOWEVER, THE TWO GUIDE WIRES \"COLLAPSED\". THE PHYSICIAN ADVANCED A 3.5MM X 9MM MAVERICK BALLOON CATHETER ALONG ONE OF THE GUIDE WIRES AND A 2.5MM X 9MM MAVERICK BALLOON CATHETER ALONG THE OTHER GUIDE WIRE IN AN EFFORT TO RELEASE THE GUIDE WIRES BUT WAS UNSUCCESSFUL. TWO OTHER LUGE GUIDE WIRES WERE ADVANCED, HOWEVER, THE GUIDE WIRE BECAME ENTANGLED. UPON ATTEMPTING TO \"YANK\" THE GUIDE WIRES IN AN EFFORT TO RELEASE THEM, A PORTION OF ONE OF THE GUIDE WIRES \"SHEARED OFF\". THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S SNARE DEVICE AND WAS ABLE TO SUCCESSFULLY RETRIEVE THE DETACHED PORTION OF THE GUIDE WIRE ALONG WITH THE 4 ENTANGLED GUIDE WIRES. THE PT'S STATUS IS REPORTED AS \"OK\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "8600 NW 41ST ST.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MIAMI", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00452", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "K923480", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33166 6202", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "LUGE", "generic_name": "DQX WIRE, GUIDE, CATHETER", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MIAMI", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080205", "device_report_product_code": "DQX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ], "device_name": "Wire, Guide, Catheter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1330", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "620", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "3.5MM X 9MM DRIVER OTW", " 2MM MICRO-SNARE KIT", " 6FR JL 4.0", " 4MM MICRO-SNARE KIT", " 5FR PINNACLE SHEATH", " 4FR GOOSE NECK SNARE 5MM", " 3.5MM X 12MM TAXUS STENT", " 8FR FL 3.5 SH LAUNCHER", " 8FR JR 4.0 SH LAUNCHER", " 8FR PINNACLE SHEATH", " 6FR PINNACLE SHEATH" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000126", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "33166", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "18914930", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS MFR REPORT# 2134265-2008-00453. SAME CASE AS MFR REPORT# 2134265-2008-00454. SAME CASE AS MFR REPORT# 2134265-2008-00455. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE SEPARATION OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PERCENT OF THE STENOSIS, DEGREE OF CALCIFICATION, AND VESSEL TORTUOUSITY ARE UNK. A 300CM LUGE GUIDE WIRE WAS ADVANCED TO THE LESION AND AN UNSPECIFIED 3.5MM X 12MM STENT WAS IMPLANTED IN THE LAD. A SECOND 300CM LUGE GUIDE WIRE WAS ADVANCED, HOWEVER, THE TWO GUIDE WIRES \"COLLAPSED\". THE PHYSICIAN ADVANCED A 3.5MM X 9MM MAVERICK BALLOON CATHETER ALONG ONE OF THE GUIDE WIRES AND A 2.5MM X 9MM MAVERICK BALLOON CATHETER ALONG THE OTHER GUIDE WIRE IN AN EFFORT TO RELEASE THE GUIDE WIRES BUT WAS UNSUCCESSFUL. TWO OTHER LUGE GUIDE WIRES WERE ADVANCED, HOWEVER, THE GUIDE WIRES BECAME ENTANGLED. UPON ATTEMPTING TO \"YANK\" THE GUIDE WIRES IN AN EFFORT TO RELEASE THEM, A PORTION OF ONE OF THE GUIDE WIRES \"SHEARED OFF\". THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S SNARE DEVICE AND WAS ABLE TO SUCCESSFULLY RETRIEVE THE DETACHED PORTION OF THE GUIDE WIRE ALONG WITH THE 4 ENTANGLED GUIDE WIRES. THE PT'S STATUS IS REPORTED AS \"OK\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "8600 NW 41ST ST.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MIAMI", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00454", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "K923480", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33166 6202", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "LUGE", "generic_name": "DQX WIRE, GUIDE, CATHETER", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MIAMI", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080205", "device_report_product_code": "DQX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ], "device_name": "Wire, Guide, Catheter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1330", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "620", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "6FR JL 4.0", " 5FR PINNACLE SHEATH", " 4MM MICRO-SNARE KIT", " 3.5MM X 12MM TAXUS STENT", " 8FR FL 3.5 SH LAUNCHER", " 3.5MM X 9MM DRIVER OTW", " 8FR JR 4.0 SH LAUNCHER", " 8FR PINNACLE SHEATH", " 4FR GOOSE NECK SNARE 5MM", " 2MM MICRO-SNARE KIT", " 6FR PINNACLE SHEATH" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000127", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "33166", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "19459449", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS MFR REPORT# 2134265-2008-00452. SAME CASE AS MFR REPORT# 2134265-2008-00453. SAME CASE AS MFR REPORT# 2134265-2008-00455. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE SEPARATION OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PERCENT OF THE STENOSIS, DEGREE OF CALCIFICATION, AND VESSEL TORTUOUSITY ARE UNK. A 300CM LUGE GUIDE WIRE WAS ADVANCED TO THE LESION AND AN UNSPECIFIED 3.5MM X 12MM STENT WAS IMPLANTED IN THE LAD. A SECOND 300CM LUGE GUIDE WIRE WAS ADVANCED, HOWEVER, THE TWO GUIDE WIRES \"COLLAPSED\". THE PHYSICIAN ADVANCED A 3.5MM X 9MM MAVERICK BALLOON CATHETER ALONG ONE OF THE GUIDE WIRES AND A 2.5MM X 9MM MAVERICK BALLOON CATHETER ALONG THE OTHER GUIDE WIRE IN AN EFFORT TO RELEASE THE GUIDE WIRES BUT WAS UNSUCCESSFUL. TWO OTHER LUGE GUIDE WIRES WERE ADVANCED, HOWEVER, THE GUIDE WIRES BECAME ENTANGLED. UPON ATTEMPTING TO \"YANK\" THE GUIDE WIRES IN AN EFFORT TO RELEASE THEM, A PORTION OF ONE OF THE GUIDE WIRES \"SHEARED OFF\". THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S SNARE DEVICE AND WAS ABLE TO SUCCESSFULLY RETRIEVE THE DETACHED PORTION OF THE GUIDE WIRE ALONG WITH THE 4 ENTANGLED GUIDE WIRES. THE PT'S STATUS IS REPORTED AS \"OK\"." }, { "mdr_text_key": "19670160", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "8600 NW 41ST ST.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "MIAMI", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00453", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "K923480", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "33166 6202", "manufacturer_g1_state": "FL", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "LUGE", "generic_name": "DQX WIRE, GUIDE, CATHETER", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MIAMI", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080205", "device_report_product_code": "DQX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ], "device_name": "Wire, Guide, Catheter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1330", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "620", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "5FR PINNACLE SHEATH", " 8FR JR 4.0 SH LAUNCHER", " 2MM MICRO-SNARE KIT", " 3.5MM X 9MM DRIVER OTW", " 4MM MICRO-SNARE KIT", " 6FR JL 4.0", " 3.5MM X 12MM TAXUS STENT", " 8FR FL 3.5 SH LAUNCHER", " 8FR PINNACLE SHEATH", " 6FR PINNACLE SHEATH", " 4FR GOOSE NECK SNARE 5MM" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000128", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "33166", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "794579", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS MFR REPORT# 2134265-2008-00452. SAME CASE AS MFR REPORT# 2134265-2008-00455. SAME CASE AS MFR REPORT# 2134265-2008-00454. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE SEPARATION OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PERCENT OF THE STENOSIS, DEGREE OF CALCIFICATION, AND VESSEL TORTUOUSITY ARE UNK. A 300CM LUGE GUIDE WIRE WAS ADVANCED TO THE LESION AND AN UNSPECIFIED 3.5MM X 12MM STENT WAS IMPLANTED IN THE LAD. A SECOND 300CM LUGE GUIDE WIRE WAS ADVANCED, HOWEVER, THE TWO GUIDE WIRES \"COLLAPSED\". THE PHYSICIAN ADVANCED A 3.5MM X 9MM MAVERICK BALLOON CATHETER ALONG ONE OF THE GUIDE WIRES AND A 2.5MM X 9MM MAVERICK BALLOON CATHETER ALONG THE OTHER GUIDE WIRE IN AN EFFORT TO RELEASE THE GUIDE WIRES BUT WAS UNSUCCESSFUL. TWO OTHER LUGE GUIDE WIRES WERE ADVANCED, HOWEVER, ALL 4 OF THE GUIDE WIRES BECAME ENTANGLED. UPON ATTEMPTING TO \"YANK\" THE GUIDE WIRES IN AN EFFORT TO RELEASE THEM, A PORTION OF ONE OF THE GUIDE WIRES \"SHEARED OFF\". THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S SNARE DEVICE AND WAS ABLE TO SUCCESSFULLY RETRIEVE THE DETACHED PORTION OF THE GUIDE WIRE ALONG WITH THE 4 ENTANGLED GUIDE WIRES. THE PT'S STATUS IS REPORTED AS \"OK\"." }, { "mdr_text_key": "8093449", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "8600 NW 41ST ST.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONCE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00458", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P020009", "date_of_event": "20060516", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Foreign", "Study", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20031101", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM", "generic_name": "MAF - STENT, CORONARY", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "ONE SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "156", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311 1566", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20061101", "model_number": "3.5X16MM", "catalog_number": "H7493505016350", "lot_number": "6065995", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000129", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780641", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING PROCEDURE THE STENT COULD NOT CROSS THE LESION AND EMBOLIZED. THE TARGET LESION WAS IN THE MID RCA. ACCORDING TO INFO RECEIVED, ONE ATTEMPT WAS MADE TO CROSS THE LESION WITHOUT SUCCESS. THE 3.5X16MM EXPRESS2 BARE METAL STENT THEN EMBOLIZED INTO THE PERIPHERAL VASCULATURE. ADD'L INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED AT THIS TIME." }, { "mdr_text_key": "7934149", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILLED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00457", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P020009", "date_of_event": "20051106", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Foreign", "Study", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20050701", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "EXPRESS2 CORONARY STENT DELIVERY SYSTEM", "generic_name": "MAF - STENT, CORONARY", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "BALLYBRIT BUSINESS PARK", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20080707", "model_number": "2.75X16MM", "catalog_number": "H7493504016270", "lot_number": "7842762", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000130", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC CORPORATION", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "19490479", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING PROCEDURE THE STENT EMBOLIZED AND WAS DEPLOYED AT AN UNINTENDED SITE. THE TARGET LESION WAS IN THE 2.7X12MM, MODERATELY TORTUOUS, 55% STENOSED PROXIMAL RCA. THE SITE REPORTED THAT THE 2.75X16MM EXPRESS2 BARE METAL STENT CAME OFF OF THE DELIVERY SYSTEM WHILE ATTEMPTING TO PASS THROUGH PREVIOUSLY PLACED STENTS. THE STENT WAS CRUSHED AGAINST THE PREVIOUSLY PLACED STENTS IN THE PROXIMAL RCA USING AN ANGIOPLASTY BALLOON. THERE WERE NO PT COMPLICATIONS AS A RESULT OF THIS EVENT." }, { "mdr_text_key": "19715677", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILLED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00483", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20070801", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "3.5X32MM", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080204", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000131", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080404", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15214974", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS MFR REPORT #2134265-2008-00482. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT STRUT PLACEMENT EXTENDED ACROSS AN ADJACENT ARTERY. THE 90% STENOSED, CALCIFIED, TARGET LESION WAS IN THE EXTREMELY TORTUOUS LEFT CIRCUMFLEX (CX) AND \"HIGH LATERAL\" (HL) ARTERIES. THE PHYSICIAN SELECTED AND ATTEMPTED TO ADVANCE A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) BUT THE DEVICE WOULD NOT CROSS. AN ATLANTIS INTRAVASCULAR ULTRASOUND (IVUS) WAS UNABLE TO CROSS THE HL LESION. THE LESION WAS PREDILATED WITH A 2.5X15MM QUANTUM MAVERICK BALLOON AND THE PROXIMAL CX WAS PREDILATED WITH A 3.5X15MM QUANTUM MAVERICK BALLOON. THE 2.5X24MM TAXUS EXPRESS2 DES WAS RETRIED; HOWEVER, IT WAS STILL UNABLE TO CROSS THE LESION. DURING WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM ON THE UNK TYPE GUIDEWIRE. THE STENT WAS ABLE TO BE RETRIEVED WITH A SNARE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE ATLANTIS IVUS CATHETER AGAIN BUT IT REMAINED UNABLE TO CROSS THE LESION. THE 2.5X15MM QUANTUM MAVERICK BALLOON WAS REATTEMPTED, BUT CONTINUED TO BE UNABLE TO PASS ADEQUATELY. THE ATLANTIS IVUS CATHETER WAS ABLE TO BE ADVANCED INTO THE LEFT ANTERIOR DESCENDING ARTERY WHERE IT WAS DETERMINED THAT THE PREVIOUSLY IMPLANTED 3.5X32MM TAXUS EXPRESS2 DES APPEARED TO HAVE A STENT STRUT THAT EXTENDED INTO THE CX. THERE WAS EXTREME STENOSIS NOTED IN THE LEFT MAIN TRUNK WITH NO BACK FLOW. IVUS ALSO DETERMINED THAT THERE WAS UNSTABLE PLAQUE IN THE LMT. THE DECISION WAS MADE TO ABORT THE PERCUTANEOUS PROCEDURE AND SEND THE PT TO SURGERY. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS \"GOOD\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00482", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20070801", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20081222", "model_number": "2.5X24MM", "catalog_number": "H7493897024250", "lot_number": "11008264", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080221", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080129", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000132", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080129", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "19174645", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS MFR REPORT #2134265-2008-00483. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE 90% STENOSED, CALCIFIED, TARGET LESION WAS IN THE EXTREMELY TORTUOUS LEFT CIRCUMFLEX (CX) AND \"HIGH LATERAL\" (HL) (CASS SITE #28) ARTERIES. THE PHYSICIAN SELECTED AND ATTEMPTED TO ADVANCE A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) BUT THE DEVICE WOULD NOT CROSS. AN ATLANTIS INTRAVASCULAR ULTRASOUND (IVUS) WAS UNABLE TO CROSS THE HL LESION. THE LESION WAS PREDILATED WITH A 2.5X15MM QUANTUM MAVERICK BALLOON AND THE PROXIMAL CX WAS PREDILATED WITH A 3.5X15MM QUANTUM MAVERICK BALLOON. THE 2.5X24MM TAXUS EXPRESS2 DES WAS RETRIED; HOWEVER, IT WAS STILL UNABLE TO CROSS THE LESION. DURING WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM ON THE UNK TYPE GUIDEWIRE. THE STENT WAS ABLE TO BE RETRIEVED WITH A SNARE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE ATLANTIS IVUS CATHETER AGAIN BUT IT REMAINED UNABLE TO CROSS THE LESION. THE 2.5X15MM QUANTUM MAVERICK BALLOON WAS REATTEMPTED, BUT CONTINUED TO BE UNABLE TO PASS ADEQUATELY. THE ATLANTIS IVUS CATHETER WAS ABLE TO BE ADVANCED INTO THE LEFT ANTERIOR DESCENDING ARTERY WHERE IT WAS DETERMINED THAT THE PREVIOUSLY IMPLANTED 3.5X32MM TAXUS EXPRESS2 DES APPEARED TO HAVE A STENT STRUT THAT EXTENDED INTO THE CX. THERE WAS EXTREME STENOSIS NOTED IN THE LEFT MAIN TRUNK WITH NO BACK FLOW. IVUS ALSO DETERMINED THAT THERE WAS UNSTABLE PLAQUE IN THE LMT. THE DECISION WAS MADE TO ABORT THE PERCUTANEOUS PROCEDURE AND SEND THE PT TO SURGERY. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS \"GOOD\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00480", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080121", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "763", "date_added": "20080222", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20070801", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20081230", "model_number": "3.0X24MM", "catalog_number": "H7493897024300", "lot_number": "0011037242", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080128", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080222", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "KAMINO 6FR. JL4 GUIDE CATHETER", " BALANCE GUIDE WIRE" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080121", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000133", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080121", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "794580", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT DISLODGMENT AND STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED THROUGH THE BRACHIAL ARTERY. THE 95% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL CIRCUMFLEX (CX) ARTERY. THE LESION WAS PREDILATED WITH A 2.5X15MM MAVERICK2 BALLOON. THE TAXUS EXPRESS2 3.0X24MM DRUG ELUTING STENT WAS ADVANCED TO THE LESION, BUT THE DISTAL PORTION OF THE DEVICE BECAME CAUGHT ON CALCIFICATION IN THE LEFT MAIN TRUNK. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM; HOWEVER, THE GUIDE CATHETER LOST POSITIONING AND \"FELL OUT\" OF THE CORONARY ARTERY INTO THE AORTIC VALVE. THE DELIVERY SYSTEM REMAINED IN THE LEFT MAIN. THE PHYSICIAN ATTEMPTED TO REMOVE THE ENTIRE SYSTEM HOWEVER THE DEVICE WAS UNABLE TO PASS THROUGH THE SHEATH IN THE BRACHIAL ARTERY AND THE STENT DISLODGED. THE DISLODGED STENT WAS ABLE TO BE RETRIEVED WITH A SNARE. IT WAS FURTHER REPORTED THAT THE EDGE OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS EXPRESS2 STENT. NO FURTHER PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00474", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P050025", "date_of_event": "20071228", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Study", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20070901", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "NEXSTENT MONORAIL", "generic_name": "NIM STENT, CAROTID", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "156", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311 1566", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20080731", "model_number": "NA", "catalog_number": "M001553030", "lot_number": "C72904", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIM", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Carotid", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080130", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000134", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080130", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780642", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CLINICAL TRIAL. IT WAS REPORTED THAT DURING THE CAROTID STENTING INDEX PROCEDURE THAT A NEXSTENT JUMPED DURING DEPLOYMENT. THE TARGET LESION WAS APART OF THE RIGHT DISTAL COMMON CAROTID WITH A REFERENCE VESSEL DIAMETER OF 5.5MM, 2.0MM LENGTH, AND 80% STENOSIS. PRE-DILATATION WAS COMPLETED WITH A RESIDUAL STENOSIS OF 30% AND THE 4.0 - 9.0 X 30MM NEXSTENT WAS IMPLANTED. THE STENT JUMPED UPON DEPLOYMENT AND AN ADDITIONAL STENT WAS DEPLOYED WHICH SUCCESSFULLY COVERED THE LESION. POST STENT IMPLANTATION STENOSIS IS 20% WITH NO THROMBUS PRESENT AT THE END OF THE PROCEDURE. UPON FURTHER INFORMATION FROM THE CENTER, THE SITE PERSONNEL CONFIRMED THAT THE DELIVERY SYSTEM DID NOT MOVE DURING DEPLOYMENT AND NO ADVERSE EVENTS OR COMPLICATIONS OCCURRED AS A RESULT OF THE STENT JUMPING." }, { "mdr_text_key": "7934150", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE EVALUATION: THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00463", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "2.5X20MM", "catalog_number": "H7493897020250", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "CYPHER STENT", " SPRINTER BALLOON" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "52", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000135", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "19459450", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE LESION WAS PRE-DILATED WITH A 2.0X15MM NON BSC BALLOON. THE PHYSICIAN PLACED A TAXUS EXPRESS2 2.5X20MM DRUG ELUTING STENT TO THE 75% STENOSED LESION LOCATED IN THE CALCIFIED, DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE STENT WAS DEPLOYED AT 10 ATMS FOR 45 SECONDS, OVERLAPPING THE DISTAL PORTION OF A PREVIOUSLY PLACED NON BSC STENT. POST IVUS WAS PERFORMED AND CONFIRMED THE STENT WAS WELL POSITIONED AND WELL APPOSED. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS GOOD. TWELVE DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH CHEST PAIN AND ANGIOGRAPHY CONFIRMED A THROMBOSIS IN THE OVERLAPPED AREA OF THE PREVIOUSLY PLACED STENTS IN THE LCX. THE THROMBOSIS WAS TREATED WITH AN ASPIRATION CATHETER AND BALLOON DILATATION USING A 2.5X15MM NON BSC BALLOON. THE PATIENT WAS ON CILOSTAZOL AND ASPIRIN AT THE TIME OF THIS EVENT. CLOPIDOGREL AND ASPIRIN WERE PRESCRIBED POST PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS \"RECOVERED.\"" }, { "mdr_text_key": "19670161", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT AT THIS TIME. THE ROOT CAUSE WILL BE DOCUMENTED AS AN ANTICIPATED PROCEDURAL COMPLICATION BECAUSE OF THE LIKELIHOOD THAT THE PATIENT ANATOMY CONTRIBUTED TO THE REPORTED COMPLAINT AND DUE TO THE LACK OF INFORMATION IMPLICATING A ROOT CAUSE RELATED TO THE DEVICE. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED AS THE BATCH NUMBER IS NOT KNOWN." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9612164-2020-01690", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P100021", "date_of_event": "20200423", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "ENDURANT IIS BIFURCATED STENT GRAFT", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20190718", "model_number": "ESBF2814C103E", "catalog_number": "ESBF2814C103E", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00643169439979", "udi_public": "00643169439979", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ] } } ], "product_problems": [ "Leak/Splash" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/04/2020", "manufacturer_contact_country": "", "date_changed": "20230605", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "70 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "Injury" ] } ], "distributor_city": "", "date_report": "20200528", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001352", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200424", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189089973", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189089974", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT PERFORMED TWO YEARS AND EIGHT MONTHS LATER, SHOWED A TYPE IA ENDOLEAK WAS PRESENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED." }, { "mdr_text_key": "316483123", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B.5: ADDITIONAL INFORMATION: INTERVENTION WAS PERFORMED FIVE DAYS LATER WHERE A 28X49 CUFF WAS IMPLANTED WITH ENDOANCHORS. IT WAS REPORTED THAT THE ENDOLEAK WAS STILL VISIBLE AT THE END OF THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATENT WILL BE MONITORED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/28/2020" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00465", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "49 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080124", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000136", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "794581", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED, BY THE SPOUSE OF A PATIENT, THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, DIZZINESS, CHEST PAIN, WEAKNESS AND \"RE-NARROWING IN THE STENT\" OCCURRED. IN 2005, THE PATIENT HAD A TAXUS EXPRESS2 DRUG ELUTING STENT, UNKNOWN SIZE, IMPLANTED. ALMOST IMMEDIATELY POST IMPLANTATION, THE PATIENT EXPERIENCED SLIGHT CHEST PAIN, FREQUENT DIZZINESS AND WEAKNESS. THE PHYSICIAN PERFORMED REPEAT CARDIAC CATHETERIZATION AND NOTED \"RE-NARROWING IN THE STENT.\" THE PATIENT WAS TO FOLLOW-UP WITH THE PHYSICIAN AGAIN IN LATE 2005. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED." }, { "mdr_text_key": "8093451", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00466", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080107", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20070401", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20080907", "model_number": "2.50X20 MM", "catalog_number": "H7493896820250", "lot_number": "9564953", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "45 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000137", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "20619238", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS: 2134265-2008-00467. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE PATIENT ORIGINALLY PRESENTED WITH UNRESOLVED CHEST PAIN. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN ANGIOGRAM IDENTIFIED A THROMBUS IN THE MID LAD. THE LESION WAS PREDILATED WITH A 2.0X12MM MAVERICK BALLOON, INFLATED TO 6 ATM. A 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN MID LAD AND A 2.50X12MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN DISTAL LAD. THE STENTS WERE OVERLAPPING AND BOTH WERE POST DILATED. NO PROCEDURAL COMPLICATIONS OCCURRED. MEDICATION GIVEN: ASPIRIN, PLAVIX, INTEGRILIN, HEPARIN, BETA BLOCKER, AND NITROGLYCERIN. PLAVIX WAS PRESCRIBED. PATIENT STATUS WAS REPORTED AS \"GOOD.\" FOUR DAYS POST THE INITIAL PROCEDURE, THE PATIENT WAS BROUGHT TO THE CATH LAB DUE TO UNRESOLVED CHEST PAIN. ANGIOGRAPHY IDENTIFIED THROMBUS IN THE MID LAD PROXIMAL TO A BIFURCATION OF THE DIAGONAL (DX). THE AREA WAS PREDILATED WITH AN UNKNOWN SIZE MAVERICK BALLOON AND A 2.50X12MM TAXUS EXPRESS2 WAS PLACED. THE PATIENT HAD BEEN COMPLIANT WITH MEDICATION AS SHE HAD NOT BEEN DISCHARGED FROM THE HOSPITAL. PATIENT STATUS WAS REPORTED AS \"GOOD\" AND THE PATIENT WAS DISCHARGED 6 DAYS POST THE REINTERVENTION." }, { "mdr_text_key": "20709696", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00467", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080107", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "2.50X12 MM", "catalog_number": "H7493896812250", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "45 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080124", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000138", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "20806660", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." }, { "mdr_text_key": "20842729", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS: 2134265-2008-00466. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE PATIENT ORIGINALLY PRESENTED WITH UNRESOLVED CHEST PAIN. THE LESION BEING TREATED WAS LOCATED IN THE CALCIFIED MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN ANGIOGRAM IDENTIFIED A THROMBUS IN THE MID LAD. THE LESION WAS PREDILATED WITH A 2.0X12MM MAVERICK BALLOON, INFLATED TO 6 ATM. A 2.50X20MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN MID LAD AND A 2.50X12MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN DISTAL LAD. THE STENTS WERE OVERLAPPING AND BOTH WERE POST DILATED. NO PROCEDURAL COMPLICATIONS OCCURRED,. MEDICATION GIVEN: ASPIRIN, PLAVIX, INTEGRILIN, HEPARIN, BETA BLOCKER, AND NITROGLYCERIN. PLAVIX WAS PRESCRIBED. PATIENT STATUS WAS REPORTED WAS \"GOOD.\" FOUR DAYS POST THE INITIAL PROCEDURE, THE PATIENT WAS BROUGHT TO THE CATH LAB DUE TO UNRESOLVED CHEST PAIN. ANGIOGRAPHY IDENTIFIED THROMBUS IN THE MID LAD PROXIMAL TO A BIFURCATION OF THE DIAGONAL (DX). THE AREA WAS PREDILATED WITH AN UNKNOWN SIZE MAVERICK BALLOON AND A 2.50X12MM TAXUS EXPRESS2 WAS PLACED. THE PATIENT HAD BEEN COMPLAINT WITH MEDICATION AS SHE HAD NOT BEEN DISCHARGED FROM THE HOSPITAL. PATIENT STATUS WAS REPORTED AS \"GOOD\" AND THE PATIENT WAS DISCHARGED 6 DAYS POST THE REINTERVENTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00479", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P020009", "date_of_event": "20061113", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20030601", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM", "generic_name": "MAF STENT, CORONARY", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "156", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311 1566", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20060601", "model_number": "3.50X20MM", "catalog_number": "H7493505020350", "lot_number": "5678996", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080130", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000139", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080130", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780753", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CLINICAL STUDY: IT WAS REPORTED THAT 403 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT REQUIRED A TARGET VESSEL REINTERVENTION (TVR). THE PATIENT PRESENTED FOR TREATMENT WITH AN ACUTE MYOCARDIAL INFARCTION (MI). THE LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD). TREATMENT INCLUDED THE ADMINISTRATION OF HEPARIN AND REPRO. THERE WAS A LARGE AREA OF THROMBUS, SO A THROMBECTOMY WAS PERFORMED. THE PATIENT HAD AN EPISODE OF BRADYCARDIA AND BECAME UNRESPONSIVE WITH ASSOCIATED HYPOTENSION. ASSISTED VENTILATION WAS INITIATED AND NIPRIDE WAS GIVEN. THE PATIENT DEVELOPED HEART FAILURE WHICH WAS TREATED WITH APPROPRIATE MEDICATIONS. THE PHYSICIAN SUCCESSFULLY PLACED A 3.5X20MM EXPRESS STUDY STENT. INTRAVASCULAR ULTRASOUND GUIDANCE WAS USED WITH EXCELLENT RESULTS. AT THIS POINT INTERVENTIONAL PROCEDURE WAS COMPLETED AND INTRA-AORTIC BALLOON PUMP WAS PLACED BECAUSE OF THE PATIENT'S PULMONARY EDEMA. THE PATIENT'S STATUS IMPROVED AND SHE WAS DISCHARGED 14 DAYS LATER AFTER BEING STARTED ON HEPARIN AND COUMADIN IN STABLE CONDITION. THE RELATIONSHIP OF THE DEVICE TO THE TVR IS UNKNOWN. FOUR HUNDRED AND THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT RETURNED FOR ROUTINE HEART CATH COMPLAINT OF SHORTNESS OF BREATH WITH EXERTION. THE LAD STENT WAS PATENT WITH A MILD NEAR INTIMAL HYPERPLASIA UP TO 40% IN-STENT RESTENOSIS. THE SECOND DIAGONAL BRANCH HAD AN 80% OSTIAL STENOSIS. SUCCESSFUL BALLOON ANGIOPLASTY WAS PERFORMED IN THIS AREA." }, { "mdr_text_key": "7934151", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00484", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "NA", "date_of_event": "20080124", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20071101", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "APEX MONORAIL", "generic_name": "PTCA DILATATION CATHETER", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20101128", "model_number": "2.00X12MM", "catalog_number": "H7493895912200", "lot_number": "11313177", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080131", "device_report_product_code": "LOX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ], "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5100", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "VOYAGER 20.X15MM BALLOON", " NEOS CONQUEST PRO GUIDE WIRE" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080124", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000140", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "794701", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE AND A VESSEL RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED DISTAL LEFT CIRCUMFLEX (LCX). A NON BSC GUIDE WIRE WAS ADVANCED TO THE LESION AND WAS PREDILATED BY A 1.5MM APEX BALLOON. THE PHYSICIAN THEN CHANGED THE APEX BALLOON TO A 2.00X12MM APEX BALLOON WHICH RUPTURED AT 8 ATM. THE PHYSICIAN ALSO NOTED THAT CONTRAST MATERIAL LEAKED FROM THE PROXIMAL BOND SIDE OF THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. DURING THE PROCEDURE A \"TINY VESSEL RUPTURE\" OCCURRED AND CAUSED BLEEDING AND BLOOD FLOW TO BECOME WORSE. THE VESSEL DAMAGE WAS TREATED BY A NON BSC STENT AND IT WAS NOTED THAT THE PATIENT'S CONDITION IMPROVED AFTER THE TREATMENT. THE PATIENT'S CURRENT CONDITION IS LISTED AS \"STABLE.\" THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03920", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20170922", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2024168" ], "fei_number": [ "2024168" ], "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230718", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001405", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189079413", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189079414", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH UNSTABLE ANGINA. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X10MM BALLOON AT 13 ATMOSPHERES (ATMS), AND THE 3X15MM XIENCE STENT WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MYOCARDIAL INFARCTION (MI) 1391 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "319239790", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "9612164-2020-01691", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P100021", "date_of_event": "20200424", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "ENDURANT II ILIAC STENT GRAFT", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200116", "model_number": "ETLW1628C124E", "catalog_number": "ETLW1628C124E", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00643169467453", "udi_public": "00643169467453", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ] } } ], "product_problems": [ "Leak/Splash", "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/04/2020;11/04/2020", "manufacturer_contact_country": "", "date_changed": "20230817", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aneurysm", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20201127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001496", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200424", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "321342851", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B:5 ADDITIONAL INFORMATION RECEIVED; THE PATIENT HAD A CT PERFORMED WHICH SHOWED AN INTERNAL ILIAC ANEURYSM. IT WAS SAID IN THE PREVIOUS INTERVENTION PROCEDURE, THE PHYSICIAN HAD COILED THE LEFT INTERNAL ILIAC AT THE TIME BUT THE ANEURYSM CONTINUED TO GROW SINCE. AS A RESULT AN ENDURANT LIMB WAS IMPLANTED ON THE SAME DATE OF THE CT TO COVER INTERNAL AND EXTEND INTO THE EXTERNAL ILIAC ARTERY. THIS RESOLVED THE EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189085812", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: E SBF3214C103EE, SERIAL/LOT #: (B)(4), UBD: 21-FEB-2019, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189085813", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT PERFORMED JUST OVER TWO YEARS LATER SHOWED A TYPE III ENDOLEAK. AS PER THE PHYSICIAN IT IS THOUGHT THAT THE LIMB ETLW1628C124E HAS SEPARATED FROM THE MAIN BODY STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED." }, { "mdr_text_key": "318092001", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B:5 ADDITIONAL INFORMATION RECEIVED: IT WAS CONFIRMED THAT THE STENT GRAFT LIMBS (B)(6) AND (B)(6) HAD SEPARATED. A SECONDARY PROCEDURE WAS CARRIED OUT FIVE DAYS POST WHEN THE ENDOLEAK WAS OBSERVED ON CT, AND THE STENT GRAFT LIMBS (B)(6) AND (B)(6) WERE IMPLANTED AS TREATMENT. FOLLOW UP CT SHOWED THAT THE ENDOLEAK IS RESOLVED. THERE IS NOW NO COMPLAINT AGAINST PLI-10 (V07573832) AND PLI-20 (V07333222) MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/21/2020;11/27/2020" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-03921", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P110019", "date_of_event": "20200304", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "DISTRI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "IN", "manufacturer_contact_area_code": "951", "date_added": "20200427", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220730", "model_number": "", "catalog_number": "1070350-48", "lot_number": "9072541", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200527", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10001534", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189079135", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE STENT REMAINS IN THE PATIENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF INTIMAL DISSECTION IS LISTED IN THE XIENCE XPEDITION, EVEROLIMUS ELUTING CORONARY STENT SYSTEM, INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE." }, { "mdr_text_key": "189079136", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN 80% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED DE NOVO LESION IN THE LEFT CIRCUMFLEX ARTERY. THE 3.5X48MM XIENCE XPEDITION STENT WAS IMPLANTED; HOWEVER, A DISSECTION WAS OBSERVED AT THE PROXIMAL END OF THE STENT. AN UNSPECIFIED XIENCE XPEDITION STENT WAS USED TO SUCCESSFULLY COVER THE DISSECTION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "DR", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SAN GERMAN", "manufacturer_contact_address_1": "14201 N.W. 60TH AVE.", "manufacturer_contact_pcity": "78631362", "event_type": "Death", "report_number": "3003742446-2008-00018", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080215", "manufacturer_address_2": "", "pma_pmn_number": "P020026", "date_of_event": "20051205", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33014", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7863136240", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL, MED DIR`", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "PR", "reporter_country_code": "US", "manufacturer_contact_area_code": "786", "date_added": "20080225", "manufacturer_contact_f_name": "GAURANG", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080215", "brand_name": "CYPHER SIROLIMUS-ELUTING CORONARY STENT", "generic_name": "DRUG-ELUTING STENT (NIQ)", "manufacturer_d_name": "CORDIS LLC (PR)", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SAN GERMAN", "manufacturer_d_state": "PR", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "NA", "catalog_number": "UNK", "lot_number": "UNK", "other_id_number": "PART# NA", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7863", "patient": [ { "patient_sequence_number": "1", "date_received": "20080215", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " L" ], "patient_age": "69 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080124", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "MIAMI LAKES", "mdr_report_key": "1000155", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CORDIS LLC (PR)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "794823", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS PT HAD A STENT IMPLANTED IN THE \"MAIN LEFT RENAL ARTERY\" AND AN ADD'L STENT WITHIN TWO MOS. ONE OR MORE OF THE STENTS WERE TAXUS OR CYPHER. THE PT DIED TWO MOS LATER DUE TO IN-ORDINATE IN-STENT RESTENOSIS AND/OR OTHER COMPLICATIONS CAUSED BY THE \"DEFECTIVE STENTS\". THE DEATH CERTIFICATE LISTS THE IMMEDIATE CAUSE OF DEATH AS \"ATHEROSCLEROTIC CARDIOVASCULAR DISEASE\" WITH AN UNDERLYING CAUSE OF \"HTN\". ADD'L INFO IS NOT CURRENTLY AVAILABLE." }, { "mdr_text_key": "8093456", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PLEASE NOTE THAT THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVAL. THIS MALE PT EXPERIENCED RESTENOSIS 2 TO 4 MOS POST IMPLANTATION OF ONE OR MORE UNK BX VELOCITY CYPHER STENTS IN THE MAIN LEFT RENAL ARTERY FOLLOWED BY DEATH. THE REPORT INDICATES THAT ONE OR MORE OF THE STENTS IMPLANTED IN THE PT WERE CORDIS STENTS OR NON-CORDIS STENTS. PAST MEDICAL HISTORY IS UNK EXCEPT FOR REPORTED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE DIAGNOSED TWO YRS BEFORE HIS DEATH. THE INDICATION OF THE INDEX PROCEDURE WAS UNK. INTERVENTION WAS PERFORMED IN THE MAIN LEFT RENAL ARTERY. THE IFU STATES THAT THIS PROD IS INDICATED FOR TREATMENT OF PTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCREET DE NOVO AND IN-STENT RESTENOTIC LESIONS (EQUAL OR LESS THAN 30 MM IN LENGTH) IN NATIVE CORONARIES WITH REFERENCE DIAMETERS RANGING FROM 3.0 TO 5.0 MM. THERE IS NO INFO REGARDING PROCEDURAL DETAILS. PHARMACOLOGICAL THERAPY WAS NOT REPORTED. ONE OR MORE BX VELOCITY CYPHER STENTS OF UNK LENGTH AND DIAMETER, UNK LOT #S AND UNK EXP DATES, WERE DEPLOYED AT UNK PRESSURE IN THE MAIN LEFT RENAL ARTERY. THE REPORT DID NOT INDICATE IF THE STENTS WERE DEPLOYED IN AN OVERLAPPING MANNER. THE RESIDUAL DIAMETER STENOSIS WAS NOT REPORTED. THE REPORT DID NOT INDICATE WHAT MEDICATIONS WERE PRESCRIBED AT DISCHARGE. TWO TO FOUR MOS LATER, THE REPORT EXPLAINED THAT THE PT EXPERIENCED IN-STENT RESTENOSIS AND DIED. THERE WAS NO INFO INDICATING IN WHAT STENT OR STENTS RESTENOSIS WAS FOUND. THE DEATH CERTIFICATE ATTRIBUTED THE IMMEDIATE CAUSE OF DEATH TO THE ATHEROSCLEROTIC CARDIOVASCULAR DISEASE THE PT SUFFERED WITH AN UNDERLYING CAUSE OF HYPERTENSION. IN ADDITION, PREDIABETES WAS LISTED AS OTHER SIGNIFICANT CONDITION CONTRIBUTING TO THE DEATH. THE PRODUCT/S REMAINED IMPLANTED IN THE PT AND ARE THUS NOT AVAILABLE FOR EVAL. A DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE CONDUCTED BECAUSE THE LOT #S OF THE PRODS WERE NOT REPORTED. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. HOWEVER, USE OF CYPHER OUTSIDE ITS INDICATIONS MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. FURTHERMORE, WITH SUCH LIMITED PT AND PROCEDURAL INFO AVAILABLE FOR REVIEW, THE LACK OF PROD'S LOT #S TO PERFORM DHR REVIEWS AND THE UNAVAILABILITY OF THE PRODS TO ANALYZE, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, PROCEDURAL FACTORS IN CONJUNCTION WITH THE PT'S SERIOUS MEDICAL HISTORY AND PROGRESSIVE HLTH DETERIORATION MAY HAVE CONTRIBUTED TO THIS EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "ROAD 362 KM 0.5", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33014", "manufacturer_contact_exchange": "786", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SAN JOSE", "manufacturer_contact_address_1": "31 TECHNOLOGY DRIVE", "manufacturer_contact_pcity": "949789-8", "event_type": "Injury", "report_number": "2954740-2020-00006", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "UNK", "date_of_event": "20171231", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "02767", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "949789-868", "noe_summarized": "1", "manufacturer_contact_l_name": "ALFAGEME", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "949", "date_added": "20200427", "manufacturer_contact_f_name": "GABRIEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "THROMBECTOMY", "generic_name": "EMBOLECTOMY CATHETER", "manufacturer_d_name": "MEDOS INTERNATIONAL SARL", "manufacturer_d_address_1": "821 FOX LANE", "manufacturer_d_address_2": "", "manufacturer_d_city": "SAN JOSE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95131", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95131", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK-MICRUS THROMBECTOMY", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DXE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200506", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9497", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "80 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intracranial Hemorrhage", "Stenosis" ] } ], "distributor_city": "", "date_report": "20200406", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "10001568", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MICRUS ENDOVASCULAR", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "192192976", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT COMPLAINT # (B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION.\u00a0 INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED." }, { "mdr_text_key": "192192977", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, \u00bfVASOSPASM AS A MAJOR COMPLICATION AFTER ACUTE MECHANICAL THROMBECTOMY WITH STENT RETRIEVERS.\u00bf 2 PATIENTS WITH ACUTE CARDIOGENIC CEREBRAL EMBOLISM WHO WERE TREATED WITH STENT RETRIEVERS EXPERIENCED VASOSPASM AND POSTOPERATIVE INTRACRANIAL HEMORRHAGE. OBJECTIVE: THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE WHICH CASES ARE MORE LIKELY TO EXPERIENCE VASOSPASM AFTER THROMBECTOMY WITH STENT RETRIEVERS. METHODS: 29 PATIENTS DIAGNOSED WITH ACUTE CARDIOGENIC CEREBRAL EMBOLISM WHO WERE TREATED WITH STENT RETRIEVERS AT OUR FACILITY FROM (B)(6) 2014 TO (B)(6) 2017 WERE INCLUDED. ATHEROTHROMBOTIC BRAIN INFARCTION CASES WERE EXCLUDED BECAUSE IT WAS DIFFICULT TO EVALUATE FOR VASOSPASMS. VASOSPASM WAS DEFINED AS REVERSIBLE ARTERIAL NARROWING OF <80% OF THE NORMAL VESSEL DIAMETER AFTER USAGE OF THE STENT RETRIEVER. THE AGE, SEX, TYPE OF STENT RETRIEVER, OCCLUSION SITE, NUMBER OF PROCEDURES, THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE, DEGREE OF VASOSPASM, INTRACRANIAL HEMORRHAGE BY THE PROCEDURE, AND NEUROLOGICAL OUTCOMES WERE ANALYZED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "821 FOX LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "02767", "manufacturer_contact_exchange": "949", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE EDWARDS WAY", "manufacturer_contact_pcity": "76325505", "event_type": "Death", "report_number": "2134265-2008-00471", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "P020009", "date_of_event": "20070306", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Foreign", "Study", "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "BE", "manufacturer_contact_area_code": "763", "date_added": "20080225", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20011201", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM", "generic_name": "MAF STENT, CORONARY", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20030401", "model_number": "3.0X32MM", "catalog_number": "H7493527032300", "lot_number": "4469616", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080122", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000157", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080122", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780882", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CLINICAL TRIAL. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT DIED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 66.6% STENOSIS, A LENGTH OF 26 MM AND A REFERENCE VESSEL DIAMETER OF 2.8 MM. THE PHYSICIAN PRE-DILATED THE LESION AND PLACED A 3.0 X 32 MM EXPRESS2 BARE METAL STENT. PROCEDURAL SUCCESS WAS OBTAINED WITH LESS THAN 30% RESIDUAL STENOSIS. THE PT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX, AMONGST OTHERS. IN 2007, THE PT HAD A HIP REPLACEMENT. PER INVESTIGATOR, THE PT DID WELL FOLLOWING HIS HIP SURGERY, HE WAS AMBULATORY AND HAD NO EVIDENCE OF DEEP VEIN THROMBOSIS. THE PT WAS EXAMINED AT THE END OF FEBRUARY IN A PRIMARY HOSP BECAUSE OF SYMPTOMS DIAGNOSED AS BRONCHOPNEUMONIA. HE LEFT THE HOSP THE SAME DAY AND REC'D AN UNSPECIFIED CEPHALOSPORIN AND BRONCHODILATOR (INHALATION). ON DAY 1565, THE PT WAS FOUND DEAD AT HOME. AN AUTOPSY WAS NOT PERFORMED. IN THE OPINION OF THE PHYSICIAN, THERE IS A PROBABLE DEVICE RELATIONSHIP." }, { "mdr_text_key": "7934645", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. THE SHOP FLOOR PAPERWORK HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SHOP FLOOR PAPERWORK REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED THEREFORE THE ROOT CAUSE WILL BE DOCUMENTED AS AN 'ANTICIPATED PROCEDURAL COMPLICATION' BECAUSE OF THE LIKELIHOOD THAT THE PT ANATOMY CONTRIBUTED TO THE REPORTED DAMAGE AND DUE TO THE LACK OF INFO IMPLICATING A ROOT CAUSE RELATED TO THE DEVICE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FLAGSTAFF", "manufacturer_contact_address_1": "3450 W. KILTIE LANE", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "2017233-2008-00071", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080218", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20070921", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "86001", "reporter_occupation_code": "", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "BAUM", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "86001", "manufacturer_g1_state": "AZ", "reporter_country_code": "", "manufacturer_contact_area_code": "928", "date_added": "20080226", "manufacturer_contact_f_name": "KINDRA", "device_date_of_manufacturer": "20070701", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080218", "brand_name": "GORE TAG THORACIC ENDOPROSTHESIS", "generic_name": "ENDOVASCULAR GRAFT SYSTEM", "manufacturer_d_name": "W.L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "3450 W. KILTIE LANE", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86001", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86001", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20100717", "model_number": "WLG326", "catalog_number": "TAG2610", "lot_number": "05201658", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2017233" ], "fei_number": [ "2017233" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20080218", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "1000177", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080120", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "86001", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "W.L. GORE & ASSOCIATES, INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780887", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IN 2007, A GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN A POOR LOCATION AND THAT THE DEVICE DID NOT HAVE INNER CURVE WALL APPOSITION. ON THE FOLLOWING MONTH, THE DEVICE COLLAPSED. A MEDTRONIC TALENT THORACIC STENT GRAFT WAS IMPLANTED AND THE COLLAPSED DEVICE WAS REPAIRED. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE." }, { "mdr_text_key": "7934152", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3450 W. KILTIE LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86001", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03923", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2024168" ], "fei_number": [ "2024168" ], "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230712", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001775", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189079709", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189079710", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IIT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X20MM BALLOON AT 6 ATMOSPHERES (ATMS), AND THE 3X38MM XIENCE STENT WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X15MM BALLOON AT 12 ATMS. THE PATIENT DEVELOPED THROMBOSIS AND A MI ON THE SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" }, { "mdr_text_key": "318846019", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ATTACHMENT: [ARTICLE CN-030867.PDF]." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "47900 BAYSIDE PARKWAY", "manufacturer_contact_pcity": "51062417", "event_type": "Injury", "report_number": "2939204-2008-00045", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "K063312", "date_of_event": "20080129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94538", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "5106241719", "noe_summarized": "1", "manufacturer_contact_l_name": "HANUSEK", "source_type": [ "Foreign", "Health Professional", "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "510", "date_added": "20080225", "manufacturer_contact_f_name": "TWEED", "device_date_of_manufacturer": "20071101", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "F/G ATLANTIS SR PRO2", "generic_name": "CORONARY IMAGING CATHETER", "manufacturer_d_name": "BOSTON SCIENTIFIC CORP.", "manufacturer_d_address_1": "47900 BAYSIDE PARKWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "FREMONT", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94538", "manufacturer_d_zip_code_ext": "651", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94538 6515", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20081125", "model_number": "39014", "catalog_number": "39014", "lot_number": "11300799", "other_id_number": "NA", "device_availability": "Yes", "date_returned_to_manufacturer": "20080206", "device_report_product_code": "DQO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Intravascular, Diagnostic", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1200", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "5106", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "BSC-TAXUS STENT", " MEDTRONIC-SPRINTER BALLOON CATHETER", " ASAHI INTECC CO. LTD-NEO'S RINATO GUIDEWIRE", " (UNKNOWN) -BALLOON CATHETER", " MEDTRONIC-EBU GUIDE CATHETER" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080129", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "FREMONT", "mdr_report_key": "1000182", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080129", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "19175519", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A PHYSICIAN HAD DIFFICULTIES RETRIEVING AN IMAGING CATHETER. THE TARGET LESION WAS 90% STENOSED AND CALCIFIED WITH MODERATE TORTUOSITY IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AREA. A GUIDEWIRE AND GUIDECATHETER WERE USED TO ACCESS THE LESION VIA FEMORAL APPROACH. THE AREA BEING TREATED WAS PRE-DILATED WITH A BALLOON CATHETER AND A STENT WAS IMPLANTED AND POST-DILATED. FOLLOWING STENT DILATION, THE INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. DURING REMOVAL OF THE IVUS CATHETER, THE PHYSICIAN EXPERIENCED DIFFICULTIES REMOVING THE IMAGING CATHETER. THE PHYSICIAN THEN REMOVED THE IMAGING CORE BY DETACHING THE PROXIMAL SHEATH FROM THE MALE AND FEMALE LUER CONNECTORS. A GUIDEWIRE WAS INSERTED INTO THE DISTAL SHEATH ASSEMBLY; HOWEVER, THE RELEASE ATTEMPT WAS UNSUCCESSFUL. A BALLOON CATHETER WAS INSERTED ALONG THE GUIDEWIRE AND IMAGING CATHETER; THEREFORE, ALLOWING THE DISTAL SHEATH ASSEMBLY TO BE RELEASED FROM THE STENT. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94538", "manufacturer_contact_exchange": "510", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FLAGSTAFF", "manufacturer_contact_address_1": "3450 WEST KILTIE LANE", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "2017233-2008-00063", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080219", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20080204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "86001", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "STEMMLER", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "86001", "manufacturer_g1_state": "AZ", "reporter_country_code": "US", "manufacturer_contact_area_code": "928", "date_added": "20080225", "manufacturer_contact_f_name": "ERIC", "device_date_of_manufacturer": "20070801", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080219", "brand_name": "GORE EXCLUDER AAA ENDOPROSTHESIS", "generic_name": "ENDOVASCULAR GRAFT SYSTEM", "manufacturer_d_name": "W.L. GORE & ASSOCIATES, INC.", "manufacturer_d_address_1": "3450 WEST KILTIE LANE", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "86001", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "86001", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20100813", "model_number": "WLG325", "catalog_number": "PXC161200", "lot_number": "05231172", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2017233" ], "fei_number": [ "2017233" ], "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20080219", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "83 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080218", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "FLAGSTAFF", "mdr_report_key": "1000186", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080204", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "86001", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "W.L. GORE & ASSOCIATES,INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "16108477", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS REPORTED, IN 2007, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. IN 2008, DURING FOLLOW-UP COMPUTED TOMOGRAPHY, IT WAS DISCOVERED THAT THE CONTRALATERAL LEG COMPONENT HAD COLLAPSED AT THE LEVEL OF THE AORTIC BIFURCATION. THE DISTAL WAIST MEASURED AT 20MM IN DIAMETER. THERE WAS NO CALCIFICATION OR THROMBUS REPORTED WITHIN THE AORTIC BIFURCATION. ON THE NEXT DAY, THIS PATIENT UNDERWENT A REINTERVENTION IN WITH BALLOONING AND IMPLANTATION OF A GUIDANT 10X38CM BARE METAL STENT WITHIN THE CONTRALATERAL LEG COMPONENT. AS REPORTED, THE PATIENT IS IN STABLE CONDITION." }, { "mdr_text_key": "16115617", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ALSO IMPLANTED IN THE PATIENT (PXT281416/LOT# 05478982, PXC181000/LOT# 05308779)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3450 WEST KILTIE LANE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "86001", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03924", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131204", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001863", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318760727", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "189078868", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE ATTACHMENT: TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189078869", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE DISTAL CIRCUMFLEX CORONARY ARTERY. THE PATIENT PRESENTED WITH ANGINA. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X15MM BALLOON AT 10 ATMOSPHERES (ATMS), AND THE 3X18MM XIENCE STENT WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MYOCARDIAL INFARCTION (MI) 3 DAYS LATER. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "1018233-2020-02850", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K983498", "date_of_event": "20200409", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "BARD\u00ae INLAY\u00ae URETERAL STENT WITH HYDROGLIDE\u00bf GUIDEWIRE", "generic_name": "URETERAL STENT", "manufacturer_d_name": "C.R. BARD, INC. (COVINGTON) -1018233", "manufacturer_d_address_1": "8195 INDUSTRIAL BLVD", "manufacturer_d_address_2": "", "manufacturer_d_city": "COVINGTON", "manufacturer_d_state": "GA", "manufacturer_d_zip_code": "30014", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "30014", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20231107", "model_number": "777628", "catalog_number": "777628", "lot_number": "NGDQ1609", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FAD", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10801741014564", "udi_public": "(01)10801741014564", "openfda": { "registration_number": [ "1018233" ], "fei_number": [ "1018233" ], "device_name": "Stent, Ureteral", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4620", "device_class": "2" } } ], "product_problems": [ "Break", "Material Fragmentation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/14/2020", "manufacturer_contact_country": "", "date_changed": "20230621", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200518", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001887", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200410", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189306240", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED." }, { "mdr_text_key": "189306241", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER OPENING THE PACKAGE OF THE INLAY URETERAL STENT, IT WAS FOUND THAT THE TUBING WAS BROKEN OFF." }, { "mdr_text_key": "317557515", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER OPENING THE PACKAGE OF THE INLAY URETERAL STENT, IT WAS FOUND THAT THE TUBING WAS BROKEN OFF." }, { "mdr_text_key": "317557516", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE \u00bfPRODUCT DAMAGED UPON ARRIVAL\u00bf WITH A POTENTIAL ROOT CAUSE OF \"INAPPROPRIATE PACKAGE DESIGN\". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: \"INSPECT ALL GUIDEWIRES FOR DAMAGE PRIOR TO USE. BENDING OR KINKING DURING OR PRIOR TO PLACEMENT COULD DAMAGE THE GUIDEWIRE. DON NOT ATTEMPT TO USE THE GUIDEWIRE IF IT HAS BEEN DAMAGED.\" CORRECTION: E1 H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/18/2020" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "*", "manufacturer_contact_address_1": "ONE SCIMED PL", "manufacturer_contact_pcity": "76325505", "event_type": "Malfunction", "report_number": "6000093-2007-01139", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20070608", "manufacturer_address_2": "", "pma_pmn_number": "K040027", "date_of_event": "20070417", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "RISK MANAGER", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE - MS A210", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080221", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20050901", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20070608", "brand_name": "EXPRESS BILIARY SD MONORAIL PREMOUNTED STENT SYSTEM", "generic_name": "FGE CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "*", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "*", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "*", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20080913", "model_number": "NA", "catalog_number": "H74937911715900", "lot_number": "8021629", "other_id_number": "*", "device_availability": "No", "device_report_product_code": "FGE", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080221", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20070608", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "*", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20070510", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "*", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000203", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "*", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "*", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "SUITE 111", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "5840 EL CAMINO REAL", "manufacturer_contact_pcity": "6035619", "event_type": "Injury", "report_number": "3009306400-2020-00017", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P160014", "date_of_event": "20200331", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6035619", "noe_summarized": "1", "manufacturer_contact_l_name": "ZUMAYA", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "603", "date_added": "20200427", "manufacturer_contact_f_name": "ERICK", "device_date_of_manufacturer": "20190502", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "COBRA PZF", "generic_name": "STENT CORONARY DELIVERY SYSTEM", "manufacturer_d_name": "CELONOVA BIOSCIENCES, INC.", "manufacturer_d_address_1": "5840 EL CAMINO REAL", "manufacturer_d_address_2": "SUITE 111", "manufacturer_d_city": "CARLSBAD, CA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220531", "model_number": "170-03-35015", "catalog_number": "170-03-35015", "lot_number": "1905024001", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200403", "device_report_product_code": "MAF", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00879397000852", "udi_public": "(01)00879397000852(17)220531(10)1905024001", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Device Dislodged or Dislocated" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200708", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6035", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "78 YR", "patient_sex": "", "patient_weight": "81", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intimal Dissection" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "CARLSABAD, CA", "mdr_report_key": "10002061", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200401", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193932810", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE STENT (WITHOUT DELIVERY SYSTEM) WAS RECEIVED 03-APR-2020. THE SITE HAD INDICATED THAT THEY RETURNED ALL THAT WAS RETAINED (WHICH WAS ONLY THE STENT). COMPLAINTS SPECIALIST PERFORMED APPLICABLE VISUAL ANALYSIS ON THE USED RETURNED STENT; THE DELIVERY SYSTEM WAS NOT RETURNED. COMPLAINTS THE CENTER SECTION OF STENT APPEARED TO BE STRETCHED AND SLIGHTLY EXPANDED WITH SLIGHTLY ROTATED / TWISTED INDIVIDUAL STRUTS. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. RISK ASSESSMENT REVIEW INDICATES THAT STENT DISLODGEMENT AND VASCULAR TRAUMA (DISSECTION) ARE CAPTURED AS KNOWN POTENTIAL OCCURRENCES. DISLODGEMENT (EX-VIVO) ROOT CAUSE: THE INVESTIGATION DETERMINED THAT A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT. THOUGH UNABLE TO BE CONFIRMED, POTENTIAL CAUSES OF DISLODGEMENT EX-VIVO MAY INCLUDE INADVERTENT ROUGH HANDLING DURING SHEATH REMOVAL AND/OR INADVERTENT SLIGHT INFLATION OF BALLOON PRIOR TO SHEATH REMOVAL AS THE RECEIVED STENT APPEARED TO BE STRETCHED AND SLIGHTLY EXPANDED WITH SLIGHTLY ROTATED / TWISTED INDIVIDUAL STRUTS; INDICATING THAT INADVERTENT INFLATION OF THE DELIVERY SYSTEM AND / OR HANDLING DAMAGE MAY HAVE OCCURRED DURING UNPACKAGING. DISSECTION ROOT CAUSE: IN GENERAL, DISSECTION CAN RESULT FROM OVEREXPANSION OF THE STENT; DISRUPTION OF THE STENT DURING WITHDRAWAL ONCE BALLOON IS DEFLATED; MIGRATION OF STENT FROM ORIGINAL POSITION BEFORE OR DURING STENT RE-EXPANSION ATTEMPT; SUBSEQUENT DEPLOYMENT OF ANOTHER OVERLAPPING STENT; AND /OR SHARP EDGE OR DAMAGE ON CATHETER TIP. WHILE THE EXACT CAUSE OF DISSECTION IS UNABLE TO BE DETERMINED IN THIS CASE, PATIENT COMBORBIDITIES AND VESSEL MORPHOLOGY ARE THE MOST PROBABLE CONTRIBUTORS TO DISSECTION AS THE STENT WAS NOT ON THE BALLOON WHEN THE DEVICE WAS EXPANDED. HOWEVER, A RELATIONSHIP BETWEEN THE COBRA DELIVERY SYSTEM AND REPORTED DISSECTION CANNOT BE COMPLETELY EXCLUDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THERE IS NO EVIDENCE OF A DEVICE DEFICIENCY." }, { "mdr_text_key": "193932811", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A (B)(6) YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, DIABETES MELLITUS TYPE 2, HYPERTENSION, DYSLIPIDEMIA, AND EX-SMOKER PRESENTED WITH STABLE ANGINA AND ATRIAL FIBRILLATION. THE PATIENT ENROLLED IN A COBRA TRIAL. ON (B)(6) 2020, DIAGNOSTIC ANGIOGRAPHY SHOWED A 70-90% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, AND 70% STENOSIS IN MARGINAL BRANCH. AFTER PRE-DILATING THE LESION, A 3.5X15 COBRA PZF\u00bf NANOCOATED CORONARY STENT SYSTEM WAS UNPACKAGED WHEN THE STENT CAME OFF OF THE BALLOON IN THE STYLET (SHEATH) PRIOR TO USE. THE DISLODGEMENT WAS NOT YET DETECTED UNTIL THE DELIVERY SYSTEM WAS ADVANCED THEN DEPLOYMENT ATTEMPT MADE; IT WAS THEN DISCOVERED THAT THE STENT HAD DISLODGED OUTSIDE OF PATIENT (IN SHEATH) PRIOR TO USE. WHEN INFLATING THE DELIVERY SYSTEM, (PERCEIVED AS DEPLOYMENT ATTEMPT), A DISSECTION OCCURRED. A 3.5X30MM COBRA STENT WAS THEN DEPLOYED OVER THE LESION AND TO TREAT THE DISSECTION SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND THE PATIENT DISCHARGED ON (B)(6)2020." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "603", "manufacturer_contact_pcountry": "760", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FREMONT", "manufacturer_contact_address_1": "31 TECHNOLOGY DRIVE", "manufacturer_contact_pcity": "949789-8", "event_type": "Injury", "report_number": "3008114965-2020-00138", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "UNK", "date_of_event": "20170131", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92618", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "949789-868", "noe_summarized": "1", "manufacturer_contact_l_name": "ALFAGEME", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94538", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "949", "date_added": "20200427", "manufacturer_contact_f_name": "GABRIEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "REVIVE SE 4.5MM OUS", "generic_name": "EMBOLECTOMY CATHETER", "manufacturer_d_name": "MEDOS INTERNATIONAL SARL", "manufacturer_d_address_1": "CHEMIN-BLANC 38", "manufacturer_d_address_2": "", "manufacturer_d_city": "LE LOCLE NEUCHATEL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "CH-24", "manufacturer_d_zip_code_ext": "00", "manufacturer_d_country": "SZ", "manufacturer_d_postal_code": "CH-2400", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "FRS21452299", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DXE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200506", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9497", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Embolism" ] } ], "distributor_city": "", "date_report": "20200407", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "10002062", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94538", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CODMAN & SHURTLEFF, INC. (FREMONT)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "192175531", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT COMPLAINT # (B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION.\u00a0 INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. CERENOVUS MANUFACTURER'S REPORT NUMBERS: 3008114965-2020-00139. 3008114965-2020-00140. 3008114965-2020-00141. 3008114965-2020-00142. ARE RELATED TO THE SAME INCIDENT." }, { "mdr_text_key": "192175532", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, \u00bfEFFECTIVENESS OF REVIVE SE IN THE RAPID REGISTRY REVIVE ACUTE ISCHEMIC STROKE PATIENTS IMMEDIATELY (RAPID) PROSPECTIVE MULTICENTER TRIAL\u00bf. 5 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO WERE TREATED WITH THE REVIVE SE EXPERIENCED THROMBOEMBOLIC OCCLUSION OF A PREVIOUSLY UNAFFECTED ARTERY. PURPOSE THE PROSPECTIVE, MULTICENTER REVIVE ACUTE ISCHEMIC STROKE PATIENTS IMMEDIATELY (RAPID) TRIAL WAS CARRIED OUT TO EVALUATE THE REAL-WORLD SAFETY AND EFFICACY OF THE REVIVE SE STENT RETRIEVER. METHODS FROM JANUARY 2017 THE STUDY PLANNED TO ENROLL 100 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO WERE TREATED WITH THE REVIVE SE AS A FIRST PASS. CERENOVUS DEVICES (REVIVE STENT RETRIEVERS) WERE USED IN THIS STUDY. NO DEVICES SPECIFIC INFORMATION (INCLUDING CATALOG AND THE LOT NUMBER) WERE PROVIDED IN THE ARTICLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "47709 FREMONT BLVD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "92618", "manufacturer_contact_exchange": "949", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03928", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131202", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE DRUG ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10002065", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318761511", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA." }, { "mdr_text_key": "189073638", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, THROMBOSIS, AND OCCLUSION ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, OCCLUSION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189073639", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE PROXIMAL TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3X15MM BALLOON AT 16 ATMOSPHERES (ATMS), AND THE 3.5X15MM XIENCE STENT WAS IMPLANTED AT 12 ATMS. POST-DILATATION WAS NOT PERFORMED. THE PATIENT DEVELOPED THROMBOSIS AND A MI 1 DAY LATER. ADDITIONALLY, THERE WAS REPORTED STENT JAILING (OCCLUSION) OF AN UNSPECIFIED VESSEL. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FREMONT", "manufacturer_contact_address_1": "31 TECHNOLOGY DRIVE", "manufacturer_contact_pcity": "949789-8", "event_type": "Injury", "report_number": "3008114965-2020-00140", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "UNK", "date_of_event": "20170131", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92618", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "949789-868", "noe_summarized": "1", "manufacturer_contact_l_name": "ALFAGEME", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94538", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "949", "date_added": "20200427", "manufacturer_contact_f_name": "GABRIEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "REVIVE SE 4.5MM OUS", "generic_name": "EMBOLECTOMY CATHETER", "manufacturer_d_name": "MEDOS INTERNATIONAL SARL", "manufacturer_d_address_1": "CHEMIN-BLANC 38", "manufacturer_d_address_2": "", "manufacturer_d_city": "LE LOCLE NEUCHATEL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "CH-24", "manufacturer_d_zip_code_ext": "00", "manufacturer_d_country": "SZ", "manufacturer_d_postal_code": "CH-2400", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "FRS21452299", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DXE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200506", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9497", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage, Cerebral" ] } ], "distributor_city": "", "date_report": "20200407", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "10002095", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94538", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CODMAN & SHURTLEFF, INC. (FREMONT)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "192189570", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT COMPLAINT # (B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. CERENOVUS MANUFACTURER'S REPORT NUMBERS: 3008114965-2020-00138. 3008114965-2020-00139. 3008114965-2020-00141. 3008114965-2020-00142. ARE RELATED TO THE SAME INCIDENT." }, { "mdr_text_key": "192189571", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, \u00bfEFFECTIVENESS OF REVIVE SE IN THE RAPID REGISTRY REVIVE ACUTE ISCHEMIC STROKE PATIENTS IMMEDIATELY (RAPID) PROSPECTIVE MULTICENTER TRIAL.\u00bf 7 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO WERE TREATED WITH THE REVIVE SE EXPERIENCED INTRAPARENCHYMAL HEMORRHAGE. PURPOSE THE PROSPECTIVE, MULTICENTER REVIVE ACUTE ISCHEMIC STROKE PATIENTS IMMEDIATELY (RAPID) TRIAL WAS CARRIED OUT TO EVALUATE THE REAL-WORLD SAFETY AND EFFICACY OF THE REVIVE SE STENT RETRIEVER. METHODS FROM JANUARY 2017 THE STUDY PLANNED TO ENROLL 100 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO WERE TREATED WITH THE REVIVE SE AS A FIRST PASS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "47709 FREMONT BLVD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "92618", "manufacturer_contact_exchange": "949", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FREMONT", "manufacturer_contact_address_1": "31 TECHNOLOGY DRIVE", "manufacturer_contact_pcity": "949789-8", "event_type": "Injury", "report_number": "3008114965-2020-00139", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "UNK", "date_of_event": "20170131", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92618", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "949789-868", "noe_summarized": "1", "manufacturer_contact_l_name": "ALFAGEME", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94538", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "949", "date_added": "20200427", "manufacturer_contact_f_name": "GABRIEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "REVIVE SE 4.5MM OUS", "generic_name": "EMBOLECTOMY CATHETER", "manufacturer_d_name": "MEDOS INTERNATIONAL SARL", "manufacturer_d_address_1": "CHEMIN-BLANC 38", "manufacturer_d_address_2": "", "manufacturer_d_city": "LE LOCLE NEUCHATEL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "CH-24", "manufacturer_d_zip_code_ext": "00", "manufacturer_d_country": "SZ", "manufacturer_d_postal_code": "CH-2400", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "FRS21452299", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DXE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200709", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9497", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Embolism" ] } ], "distributor_city": "", "date_report": "20200407", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "10002109", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94538", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CODMAN & SHURTLEFF, INC. 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CERENOVUS MANUFACTURER'S REPORT NUMBERS: 3008114965-2020-00138. 3008114965-2020-00140. 3008114965-2020-00141. 3008114965-2020-00142. ARE RELATED TO THE SAME INCIDENT." }, { "mdr_text_key": "193347101", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, \u00bfEFFECTIVENESS OF REVIVE SE IN THE RAPID REGISTRY REVIVE ACUTE ISCHEMIC STROKE PATIENTS IMMEDIATELY (RAPID) PROSPECTIVE MULTICENTER TRIAL.\u00bf 5 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO WERE TREATED WITH THE REVIVE SE EXPERIENCED DISTAL EMBOLIZATION EVENTS. PURPOSE THE PROSPECTIVE, MULTICENTER REVIVE ACUTE ISCHEMIC STROKE PATIENTS IMMEDIATELY (RAPID) TRIAL WAS CARRIED OUT TO EVALUATE THE REAL-WORLD SAFETY AND EFFICACY OF THE REVIVE SE STENT RETRIEVER. METHODS FROM JANUARY 2017 THE STUDY PLANNED TO ENROLL 100 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO WERE TREATED WITH THE REVIVE SE AS A FIRST PASS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "47709 FREMONT BLVD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "92618", "manufacturer_contact_exchange": "949", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FREMONT", "manufacturer_contact_address_1": "31 TECHNOLOGY DRIVEP", "manufacturer_contact_pcity": "949789-8", "event_type": "Injury", "report_number": "3008114965-2020-00141", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "UNK", "date_of_event": "20170131", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92618", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "949789-868", "noe_summarized": "1", "manufacturer_contact_l_name": "ALFAGEME", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94538", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "949", "date_added": "20200427", "manufacturer_contact_f_name": "GABRIEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "REVIVE SE 4.5MM OUS", "generic_name": "EMBOLECTOMY CATHETER", "manufacturer_d_name": "MEDOS INTERNATIONAL SARL", "manufacturer_d_address_1": "CHEMIN-BLANC 38", "manufacturer_d_address_2": "", "manufacturer_d_city": "LE LOCLE NEUCHATEL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "CH-24", "manufacturer_d_zip_code_ext": "00", "manufacturer_d_country": "SZ", "manufacturer_d_postal_code": "CH-2400", "device_operator": "0", "model_number": "", "catalog_number": "FRS21452299", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DXE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200708", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9497", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage, Subarachnoid" ] } ], "distributor_city": "", "date_report": "20200407", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "10002115", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94538", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CODMAN & SHURTLEFF, INC. 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INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED." }, { "mdr_text_key": "193946161", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, \u00bfEFFECTIVENESS OF REVIVE SE IN THE RAPID REGISTRY REVIVE ACUTE ISCHEMIC STROKE PATIENTS IMMEDIATELY (RAPID) PROSPECTIVE MULTICENTER TRIAL.\u00bf 1 PATIENT WITH ACUTE ISCHEMIC STROKE WHO WAS TREATED WITH THE REVIVE SE EXPERIENCED POST-PROCEDURE SUBARACHNOID HEMORRHAGE. PURPOSE THE PROSPECTIVE, MULTICENTER REVIVE ACUTE ISCHEMIC STROKE PATIENTS IMMEDIATELY (RAPID) TRIAL WAS CARRIED OUT TO EVALUATE THE REAL-WORLD SAFETY AND EFFICACY OF THE REVIVE SE STENT RETRIEVER. METHODS FROM JANUARY 2017 THE STUDY PLANNED TO ENROLL 100 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO WERE TREATED WITH THE REVIVE SE AS A FIRST PASS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "47709 FREMONT BLVD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "92618", "manufacturer_contact_exchange": "949", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "FREMONT", "manufacturer_contact_address_1": "31 TECHNOLOGY DRIVEPP", "manufacturer_contact_pcity": "949789-8", "event_type": "Injury", "report_number": "3008114965-2020-00142", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "UNK", "date_of_event": "20170131", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92618", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "949789-868", "noe_summarized": "1", "manufacturer_contact_l_name": "ALFAGEME", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94538", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "949", "date_added": "20200427", "manufacturer_contact_f_name": "GABRIEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "REVIVE SE 4.5MM OUS", "generic_name": "EMBOLECTOMY CATHETER", "manufacturer_d_name": "MEDOS INTERNATIONAL SARL", "manufacturer_d_address_1": "CHEMIN-BLANC 38", "manufacturer_d_address_2": "", "manufacturer_d_city": "LE LOCLE NEUCHATEL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "CH-24", "manufacturer_d_zip_code_ext": "00", "manufacturer_d_country": "SZ", "manufacturer_d_postal_code": "CH-2400", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "FRS21452299", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DXE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200708", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9497", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "66 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intracranial Hemorrhage" ] } ], "distributor_city": "", "date_report": "20200407", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "IRVINE", "mdr_report_key": "10002116", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200407", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94538", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CODMAN & SHURTLEFF, INC. 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METHODS FROM (B)(6) 2017 THE STUDY PLANNED TO ENROLL 100 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO WERE TREATED WITH THE REVIVE SE AS A FIRST PASS. CERENOVUS DEVICES (REVIVE STENT RETRIEVERS) WERE USED IN THIS STUDY. NO DEVICES SPECIFIC INFORMATION (INCLUDING CATALOG AND THE LOT NUMBER) WERE PROVIDED IN THE ARTICLE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "47709 FREMONT BLVD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "92618", "manufacturer_contact_exchange": "949", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "35 ENTERPRISE DRIVE", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2032493-2020-00111", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P170013", "date_of_event": "20200331", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "MANUS", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "EVA", "device_date_of_manufacturer": "20181127", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "LVIS JR 2.5X17", "generic_name": "INTRALUMINAL SUPPORT DEVICE", "manufacturer_d_name": "MICROVENTION, INC.", "manufacturer_d_address_1": "35 ENTERPRISE", "manufacturer_d_address_2": "", "manufacturer_d_city": "ALISO VIEJO, CA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211031", "model_number": "MV-L251717", "catalog_number": "", "lot_number": "18112753Z", "other_id_number": "", "device_availability": "No", "device_report_product_code": "QCA", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "04987350998477", "udi_public": "(01)04987350998477(11)181127(17)211031(10)18112753Z", "openfda": { "device_name": "Intracranial Coil-Assist Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200518", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "70", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Thrombus" ] } ], "distributor_city": "", "date_report": "20200401", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "ALISO VIEJO, CA", "mdr_report_key": "10002289", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200401", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189561995", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES THROMBOSIS AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE." }, { "mdr_text_key": "189561996", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT STENT-ASSISTED COILING WAS PERFORMED FOR AN ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY. AFTER THE LVIS JR. WAS IMPLANTED AND COILS WERE PLACED IN THE ANEURYSM, ANGIOGRAPHY REVEALED IN-STENT THROMBOSIS AND IT APPEARED THAT PART OF AN IMPLANTED COIL EXTENDED OUT OF THE ANEURYSM. ANOTHER COMPANY'S STENT WAS IMPLANTED AT THE TREATMENT SITE WITHIN THE STENT USING A Y-CONFIGURED TECHNIQUE. HEPARIN WAS INCREASED, UROKINASE WAS INJECTED, AND BALLOON DILATATION CATHETERS WERE ALSO USED FOR TREATMENT. IT WAS CONFIRMED THAT THERE WAS NO HEALTH DAMAGE TO THE PATIENT OR SEQUELAE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "OTHER", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL COUNTY TIPPERY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191420", "event_type": "Malfunction", "report_number": "2024168-2008-00114", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080214", "manufacturer_address_2": "", "pma_pmn_number": "PO20047", "date_of_event": "20071013", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519142050", "noe_summarized": "1", "manufacturer_contact_l_name": "VINMANS", "source_type": [ "Foreign", "Health Professional", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "UY", "manufacturer_contact_area_code": "951", "date_added": "20080428", "manufacturer_contact_f_name": "DENISE", "device_date_of_manufacturer": "20070601", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080214", "brand_name": "MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM", "generic_name": "74MAF", "manufacturer_d_name": "ABBOTT VASCULAR-CARDIAC THERAPIES", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "462", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92591 4628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20100512", "model_number": "NA", "catalog_number": "1007829-15", "lot_number": "7061231", "other_id_number": "NA", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20080122", "device_report_product_code": "MAF", "device_age_text": "NA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080428", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20080214", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "UNK", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080118", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "1000246", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080121", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR CLONMEL", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "781235", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTING RATIONALE: MALFUNCTION. REPORTING STATUS: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DID NOT CROSS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE EVENT IS BEING REPORTED BASED ON THE RETURNED DEVICE ANALYSIS WHICH REVEALED THAT THE STENT WAS PARTIALLY DISLODGED FROM THE BALLOON." }, { "mdr_text_key": "7947940", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "RESULTS: PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS PUSHED DISTALLY 1.4 CM WITH THE PROXIMAL END OF THE STENT OVER THE DISTAL BALLOON MARKER AND THE DISTAL END OF THE STENT NO LONGER ON THE BALLOON. THE ENTIRE LENGTH OF THE STENT IMPLANT WAS SMASHED. THE FIRST ROW OF PROXIMAL STRUTS WAS SEVERELY DAMAGED. THE FIRST TWO ROWS OF DISTAL STRUTS WERE MANGLED. THERE WERE SEVERAL FLARED AND BENT BACK STRUTS THROUGHOUT THE ENTIRE LENGTH OF THE STENT IMPLANT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS LOOSELY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS. THERE WAS A KINK IN THE HYPOTUBE, 1 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WERE TWO KINKS IN THE HYPOTUBE, 15 CM AND 21 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WERE NO KINKS OR DAMAGE NOTED TO THE INNER MEMBER OR TIP. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. THE TIP SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE OUTER DIAMETER MEASUREMENTS OF THE STENT IMPLANT COULD NOT BE TAKEN DUE TO THE DAMAGE. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED DEVICE. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. NO DAMAGE WAS REPORTED AS BEING NOTED TO THE SDS DURING THE INSPECTION PRIOR TO USE; HOWEVER, ANALYSIS OF THE DEVICE NOTED THAT THE STENT IMPLANT WAS DAMAGED AND MISLOCATED DISTALLY, PARTIALLY OFF THE BALLOON. THERE WAS BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE BALLOON WAS LOOSELY FOLDED, WHICH SUGGESTS THAT THE DEVICE HAD BEEN PREPARED FOR USE, A GUIDE WIRE LOADED INTO THE GUIDE WIRE LUMEN AND THE BALLOON AT LEAST PARTIALLY INFLATED. CRIMP MARKS WERE VISIBLE ON THE BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. POTENTIAL CAUSES OF STENT MOVEMENT ARE, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY, AND LESION MORPHOLOGY. ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT MOVEMENT CRITERIA. THE LOT HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS LOT. THE RELEASE TESTING DATA WAS ALSO REVIEWED. ALL SAMPLES FROM THIS LOT PASSED TESTING FOR STENT PLACEMENT, CRIMPED STENT OUTER DIAMETER, AND STENT MOVEMENT, INDICATING THE UNITS HAD AN ADEQUATE CRIMP. THE STENT IMPLANT WAS RETURNED WITH SEVERELY DAMAGED STRUTS ON THE PROXIMAL AND DISTAL ENDS. DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE DEVICE. DAMAGE TO THE DISTAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE ANATOMY AND/OR ACCESSORIES DURING ADVANCEMENT OF THE DEVICE. IN ADDITION, THE STENT WAS FLATTENED ON THE ENTIRE LENGTH, WITH MULTIPLE FLARED AND BENT STRUTS AND THREE KINKS WERE NOTED IN THE HYPOTUBE, WHICH WERE NOT REPORTED TO THE INCIDENT AND MAY HAVE OCCURRED DURING THE PACKING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. UNFORTUNATELY, WITH THE LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED FAILURE TO CROSS, HOWEVER, THERE DOES NOT APPEAR TO BE A PRODUCT QUALITY ISSUE. PRODUCT PERFORMANCE ENGINEERING WILL TREND AND MONITOR THE EXPERIENCED CIRCUMSTANCES. THE PROFILE DIMENSIONS ON ALL CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE AT ABBOTT VASCULAR. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL RD.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL COUNTY, TIPPERY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191420", "event_type": "Malfunction", "report_number": "2024168-2008-00104", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080214", "manufacturer_address_2": "", "pma_pmn_number": "PO20047", "date_of_event": "20080114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9519142050", "noe_summarized": "1", "manufacturer_contact_l_name": "VINMANS", "source_type": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SN", "manufacturer_contact_area_code": "951", "date_added": "20080425", "manufacturer_contact_f_name": "DENISE", "device_date_of_manufacturer": "20070801", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080214", "brand_name": "MULTI-LINK RX VISION CORONARY STENT SYSTEM", "generic_name": "74MAF", "manufacturer_d_name": "ABBOTT VASCULAR-CARDIAC THERAPIES", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "462", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92591 4628", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20100729", "model_number": "NA", "catalog_number": "1007843-18", "lot_number": "7082931", "other_id_number": "NA", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "NA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080425", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20080214", "sequence_number_treatment": [ "INFLATION: PRIORITY PACK", " GUIDE WIRE: GALEO - J TIP", " SHEATH: 7F", " GUIDE CATH: EJR 3.5 6F", " DIL CATH: SPRINTER" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "72", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080118", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "1000251", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080118", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR CLONMEL", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "795195", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REPORTING STATUS: SERIOUS INJURY/ MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT WHILE IMPLANTING THE MULTI LINK VISION STENT, THE PROXIMAL EDGE OF THE STENT CAUSED A DISSECTION OF THE RCA VESSEL. A 3.5 X 13 MM MULTI-LINK ZETA STENT WAS USED TO TREAT THE DISSECTION. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE." }, { "mdr_text_key": "8043707", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. DISSECTION, AS LISTED IN THE DEVICE RISK ASSESSMENT AND INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS KNOWN PT EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THE REPORTED MILDLY TORTUOUS ANATOMY MAY HAVE CONTRIBUTED TO THE DIFFICULTIES, HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL RD.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3011299751-2020-00186", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K161457", "date_of_event": "20200114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XEN 45 GTS", "generic_name": "IMPLANT, EYE VALVE", "manufacturer_d_name": "ALLERGAN (IRVINE)", "manufacturer_d_address_1": "2525 DUPONT DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "IRVINE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92612", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92612", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20221031", "model_number": "", "catalog_number": "5513-001", "lot_number": "63044", "other_id_number": "", "device_availability": "No", "device_report_product_code": "KYF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Implant, Eye Valve", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.3920", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/28/2020;05/25/2020;07/31/2020;08/24/2021", "manufacturer_contact_country": "", "date_changed": "20231023", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "LEVOFLOXACIN AND TOBRAMYCIN DEXAMETHASONE." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "84 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hyperemia", "Intraocular Pressure Increased", "Iritis", "Blurred Vision" ] } ], "distributor_city": "", "date_report": "20210921", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10002657", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200330", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "326022938", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION REPORTED A CLINICAL PATIENT RIGHT EYE PRESSURE WAS NOTED TO BE HIGH WITH IOP OF 32MMHG AND BLURRED VISION. TREATMENT WAS NOTED AS BRINZOAMINE EYE DROPS, BROMOMONIDINE TARTRATE EYE DROPS AND TAFLUPROST EYE DROPS TO REDUCE THE LNTRAOCULAR PRESSURE BUT VISION WOULD NOT IMPROVE. A MONTH LATER, THE PATIENT HAD A XEN IMPLANTED IN THE FELLOW LEFT EYE AND WAS NOTED THAT THE IOP OF THE RIGHT EYE WAS STILL HIGH. ADDITIONAL MEDICATION WAS USED WITH MASSAGES TO REDUCE THE INTRAOCULAR PRESSURE. PATIENT WAS THEN HOSPITALIZED SEVEN MONTHS AFTER XEN IMPLANTATION DUE TO HYPERTENSION WITH IOP NOTED AS 25.3 MMHG. PATIENT WAS WITHDRAWN FROM THE STUDY AND UNDERWENT A PENETRATING VISCOUS DILATION PLASTY AND GONIOPLASTY. AFTER THE OPERATION, 0.5% LEVOFLOXACIN EYE DROPS, TOBRAMYCIN DEXAMETHASONE EYE DROPS AND OTHER LOCAL ANTI-INFLAMMATORY WITH PREVENTIVE TREATMENT WERE GIVEN. PATIENT WAS DISCHARGED AFTER FOUR DAYS OF HOSPITALIZATION DUE TO CLINICAL IMPROVEMENT OF OCULAR HYPERTENSION." }, { "mdr_text_key": "189715723", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE EVENTS OF CORNEAL EDEMA, HIGH INTRAOCULAR PRESSURE, HYPEREMIA OF CONJUNCTIVA, AND IRITIS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED." }, { "mdr_text_key": "189715724", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A CLINICAL PATIENT WITH A XEN 45 GEL STENT IMPLANTED IN THE RIGHT EYE EXPERIENCED A CORNEAL EDEMA, ANTERIOR CHAMBER INFLAMMATION, AND HYPEREMIA OF CONJUNCTIVA THE DAY AFTER IMPLANT. ROUGHLY TWO MONTHS FOLLOWING XEN IMPLANTATION, THE PATIENT EXPERIENCED HIGH INTRAOCULAR PRESSURE OF 31 MMHG AND RECEIVED A COMBINED OPERATION AND MEDICATION AS TREATMENT. THE EVENT OF THE HIGH INTRAOCULAR PRESSURE IS CURRENTLY RECOVERING/IMPROVING." }, { "mdr_text_key": "316426755", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: B.5." }, { "mdr_text_key": "316426756", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED NOTING THE SECOND EVENT OF CORNEAL INCISION EDEMA HAS ENDED AND WAS RECOVERED/MITIGATED." }, { "mdr_text_key": "315293103", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED NOTING THE EVENT OF HIGH INTRAOCULAR PRESSURE HAS RESOLVED. THE PATIENT AGAIN EXPERIENCED THE EVENTS OF CONJUNCTIVAL HYPEREMIA AND CORNEA INCISION EDEMA. NO TREATMENT WERE NOTED FOR THESE EVENTS AND THEY WERE NOTED AS MILD. IT WAS ALSO NOTED THE PATIENT HAD A PREVIOUS EVENT OF HIGH INTRAOCULAR PRESSURE THAT WAS MILD AND RECOVERED/RELIEVED THROUGH CONCOMITANT OPERATION AND COMBINED MEDICATION." }, { "mdr_text_key": "319290522", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION REPORTED A CLINICAL PATIENT RIGHT EYE PRESSURE WAS NOTED TO BE HIGH WITH IOP OF 32MMHG AND BLURRED VISION. TREATMENT WAS NOTED AS BRINZOAMINE EYE DROPS, BROMOMONIDINE TARTRATE EYE DROPS AND TAFLUPROST EYE DROPS TO REDUCE THE LNTRAOCULAR PRESSURE BUT VISION WOULD NOT IMPROVE. A MONTH LATER, THE PATIENT HAD A XEN IMPLANTED IN THE FELLOW LEFT EYE AND WAS NOTED THAT THE IOP OF THE RIGHT EYE WAS STILL HIGH. ADDITIONAL MEDICATION WAS USED WITH MASSAGES TO REDUCE THE INTRAOCULAR PRESSURE. PATIENT WAS THEN HOSPITALIZED SEVEN MONTHS AFTER XEN IMPLANTATION DUE TO HYPERTENSION WITH IOP NOTED AS 25.3 MMHG. PATIENT WAS WITHDRAWN FROM THE STUDY AND UNDERWENT A PENETRATING VISCOUS DILATION PLASTY AND GONIOPLASTY. AFTER THE OPERATION, 0.5% LEVOFLOXACIN EYE DROPS, TOBRAMYCIN DEXAMETHASONE EYE DROPS AND OTHER LOCAL ANTI-INFLAMMATORY WITH PREVENTIVE TREATMENT WERE GIVEN. PATIENT WAS DISCHARGED AFTER FOUR DAYS OF HOSPITALIZATION DUE TO CLINICAL IMPROVEMENT OF OCULAR HYPERTENSION." }, { "mdr_text_key": "319290523", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/27/2020;06/23/2020;08/27/2020;09/21/2021" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "3013164176-2020-00059", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P020004", "date_of_event": "20200408", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "LOPEZ", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95050", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "928", "date_added": "20200427", "manufacturer_contact_f_name": "JENNA", "device_date_of_manufacturer": "20200114", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "W.L. GORE & ASSOCIATES", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20230113", "model_number": "", "catalog_number": "PLC161200J", "lot_number": "21559154", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Inadequacy of Device Shape and/or Size", "Migration" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "", "date_changed": "20210723", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200409", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "", "mdr_report_key": "10002726", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "95050", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL SILICON VALLEY B/P", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190067263", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "190067264", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE\u00ae EXCLUDER\u00ae AAA ENDOPROSTHESES. ON (B)(6) 2020 A FOLLOW-UP CT CONFIRMED THAT THE CONTRALATERAL LEG COMPONENT, LOCATED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY, HAD MIGRATED PROXIMALLY (DISTANCE UNKNOWN). REPORTEDLY A DISTAL TYPE I ENDOLEAK WAS PRESENT. ACCORDING TO THE GORE REPRESENTATIVE AND THE PHYSICIAN, THE INITIAL TREATMENT LENGTH WAS ABOUT 11CM, SO THE 11.5CM DEVICE WAS IMPLANTED AT THE SHORTEST TREATMENT LENGTH. THE PHYSICIAN COMMENTED THAT A LONGER DEVICE SHOULD HAVE BEEN USED (13.5CM STENT GRAFT) RATHER THAN THE 11.5CM DEVICE THAT WAS USED FOR THE INDEX PROCEDURE. THE DEVICE MIGRATION IS BEING ATTRIBUTED TO DEVICE SIZING. ON (B)(6) 2020 REOPERATION WAS PERFORMED. AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS DEPLOYED IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY TO TREAT THE TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2890 DE LA CRUZ BLVD.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "AZ", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "KARLSRUHE", "manufacturer_contact_address_1": "1415 W. 3RD STREET", "manufacturer_contact_pcity": "48030326", "event_type": "Injury", "report_number": "9681442-2020-00122", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070014", "date_of_event": "20200331", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "85281", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4803032689", "noe_summarized": "1", "manufacturer_contact_l_name": "LUDWIG", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "76227", "manufacturer_g1_state": "", "reporter_country_code": "CH", "manufacturer_contact_area_code": "480", "date_added": "20200427", "manufacturer_contact_f_name": "JUDITH", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "LIFESTENT STENT SYSTEM", "generic_name": "VASCULAR STENT", "manufacturer_d_name": "ANGIOMED GMBH & CO. MEDIZINTECHNIK KG", "manufacturer_d_address_1": "WACHHAUSSTRASSE 6", "manufacturer_d_address_2": "", "manufacturer_d_city": "KARLSRUHE", "manufacturer_d_state": "", "manufacturer_d_zip_code": "76227", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "GM", "manufacturer_d_postal_code": "76227", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "EX061703C", "lot_number": "ANDQ2740", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIP", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "04049519001500", "udi_public": "(01)04049519001500", "openfda": { "registration_number": [ "9681442" ], "fei_number": [ "3002806368" ], "device_name": "Stent, Superficial Femoral Artery", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Fracture" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20210813", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4803", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "78 YR", "patient_sex": "", "patient_weight": "76", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Injury" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "GM", "manufacturer_contact_city": "TEMPE", "mdr_report_key": "10002752", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200401", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "76227", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ANGIOMED GMBH & CO. MEDIZINTECHNIK KG", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189153721", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRATION DATE: 03/2021)." }, { "mdr_text_key": "189153722", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AN RE-EXAMINATION OF THE STENT WAS PERFORM APPROXIMATELY ONE MONTH POST STENT PLACEMENT TO TREAT ARTERIAL PLAQUES IN BOTH LOWER LIMBS DUE TO PATIENT ALLEGED LEG PAIN. IT WAS FURTHER REPORTED THAT THE RE-EXAMINATION IDENTIFIED AN ALLEGED STENT FRACTURE REDUCED FLOW IN THE RIGHT POPLITEAL ARTERY. THEREFORE, REINTERVENTION SURGERY WAS PERFORMED TO REPAIR THE FRACTURED STENT BY USING A COVERED STENT RESTORING VESSEL FLOW. PATIENT DOING WELL POST INTERVENTION PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "WACHHAUSSTRASSE 6", "distributor_zip_code": "", "manufacturer_contact_postal_code": "85281", "manufacturer_contact_exchange": "480", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-03930", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P960043", "date_of_event": "20200330", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "951", "date_added": "20200427", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM", "generic_name": "SUTURE MEDIATED CLOSURE", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "12673-03", "catalog_number": "12673-03", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MGB", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08717648013089", "udi_public": "08717648013089", "openfda": { "device_name": "Device, Hemostasis, Vascular", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Off-Label Use", "Positioning Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200901", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "88", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10002832", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190141735", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE REPORTED DIFFICULTY POSITIONING THE DEVICE APPEARS TO BE RELATED TO INTERACTION WITH THE PIG TAIL DEVICE. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE ACCESS SITE WAS THE RIGHT AXILLARY ARTERY. IT SHOULD BE NOTED THAT THE PROGLIDE INSTRUCTIONS FOR USE (IFU), INDICATIONS SECTION STATES: \"THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY AND VEIN ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES.\" IN THIS CASE, THE REPORTED DIFFICULTY POSITIONING THE DEVICE APPEARS TO BE RELATED TO INTERACTION WITH THE PIG TAIL DEVICE AND NOT SPECIFICALLY THE ACCESS SITE LOCATION. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION A PRODUCT QUALITY ISSUE. THE ADDITIONAL PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATED MANUFACTURING REPORT NUMBER." }, { "mdr_text_key": "190141766", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SUTURE PLACEMENT IN A RIGHT AXILLARY ARTERY WAS ATTEMPTED ON (B)(6) 2020, WITH TWO PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE WITH THE USE OF AN IMPELLA HEART DEVICE. REPORTEDLY, THE SUTURES OF THE FIRST PROGLIDE DEVICE WERE SUCCESSFULLY PRE-PLACED. WHEN THE ATTEMPT WAS MADE WITH THE SECOND PROGLIDE DEVICE, THERE WAS INTERACTION DURING INSERTION WITH THE PIG TAIL CATHETER SO THE PROGLIDE WAS NOT DEPLOYED AND WAS REMOVED. THE SHEATH WAS UPSIZED TO A 14F AND THE PCI PROCEDURE WAS COMPLETED. THE IMPELLA HEART PUMP WAS KEPT IN PLACE AND THE PATIENT WAS SENT TO THE FLOOR. ON (B)(6) 2020, THE PATIENT WAS BROUGHT BACK INTO THE CATH LAB. THE IMPELLA WAS REMOVED AND THE SUTURES OF THE PRE-PLACED PROGLIDE WERE THEN CINCHED DOWN TO CLOSE THE ACCESS SITE. THE DECISION WAS MADE TO USE AN ADDITIONAL PROGLIDE TO CLOSE THE ACCESS SITE. UPON ADVANCING THE PROGLIDE DEVICE INTO THE ANATOMY, BLOOD RETURN FROM THE MARKER LUMEN WAS DIFFICULT TO ACHIEVE; HOWEVER, WAS ULTIMATELY ABLE TO BE OBTAINED. REPORTEDLY, THE PROGLIDE DEVICE WAS DEPLOYED PER THE INSTRUCTIONS FOR USE (IFU); HOWEVER, THERE WAS RESISTANCE WHEN ATTEMPTING TO REMOVE THE DEVICE AFTER DEPLOYMENT. THE PROGLIDE BECAME STUCK AND WAS UNABLE TO BE REMOVED. IT WAS VERIFIED UNDER FLUOROSCOPY THAT THE FOOT WAS FULLY RETRACTED. AS THE PROGLIDE DEVICE COULD NOT BE REMOVED, THE PHYSICIAN DECIDED TO \"BREAK\" THE PROGLIDE HANDLE IN ATTEMPT TO FREE THE DEVICE. AS THIS WAS UNSUCCESSFUL IN REMOVING THE DEVICE, FORCE WAS USED TO ATTEMPT THE REMOVAL OF THE PROGLIDE AND THE PROGLIDE SEPARATED AT THE \"ELBOW\" WHERE THE FOOT CONNECTS WITH THE DEVICE. THE FOOT CAME OUT LEAVING THE HYDROPHILIC SHEATH AND THE \"SHELL\" OR COVERING OF THE FOOT IN THE ARTERY. ACCESS IN THE RIGHT SUBCLAVIAN (ABOUT AN INCH DISTAL TO THE AXILLARY ACCESS) WAS ACHIEVED TO ATTEMPT \"SNARING\" OF THE PORTION OF THE PROGLIDE LEFT IN THE ARTERY. A 14F SHEATH WAS PLACED IN THE RIGHT SUBCLAVIAN ACCESS SITE. A SNARE WAS USED TO ATTEMPT TO RECOVER THE PORTION OF THE PROGLIDE LEFT IN THE ARTERY. THIS WAS NOT SUCCESSFUL AT FIRST. THE OPERATORS UPSIZED THE 14F SHEATH IN THE RIGHT SUBCLAVIAN TO A 16F SHEATH. THE REST OF THE MATERIAL OF THE PROGLIDE WAS SUCCESSFULLY REMOVED FROM THE ARTERY USING A SNARE. BOTH THE RIGHT AXILLARY SHEATH AND THE RIGHT SUBCLAVIAN SHEATHS WHERE REMOVED. HEMOSTASIS WAS ACHIEVED BY PLACING A 7 X 59 BVX COVERED STENT ACROSS BOTH THE RIGHT AXILLARY AND RIGHT SUBCLAVIAN ARTERIOTOMIES. THIS WAS DONE VIA THE 7F SHEATH IN THE RIGHT COMMON FEMORAL ARTERY (RCFA). THE COVERED STENT WAS POST DILATED WITH A 10X40 BALLOON. A BALLOON PUMP WAS PLACED INTO THE PATIENT THROUGH THE 7F SHEATH OF THE RCFA AND SENT THE PATIENT BACK TO THE FLOOR. THE PATIENT REQUIRED A BLOOD TRANSFUSION DUE TO BLEEDING FROM THE PROGLIDE ISSUE. THE PATIENT WAS REPORTEDLY STABLE AFTER THE PROCEDURE AND THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "4628", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "CLONMEL TIPPERARY", "manufacturer_contact_address_1": "26531 YNEZ RD.", "manufacturer_contact_pcity": "95191439", "event_type": "Injury", "report_number": "2024168-2020-03931", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P960043", "date_of_event": "20200402", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92591", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9519143996", "noe_summarized": "1", "manufacturer_contact_l_name": "BELL", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "951", "date_added": "20200427", "manufacturer_contact_f_name": "LINDSEY", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM", "generic_name": "SUTURE MEDIATED CLOSURE", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "12673-03", "catalog_number": "12673-03", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MGB", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08717648013089", "udi_public": "08717648013089", "openfda": { "device_name": "Device, Hemostasis, Vascular", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Entrapment of Device", "Off-Label Use", "Material Separation", "Improper or Incorrect Procedure or Method", "Obstruction of Flow" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20200901", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9519", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "88", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "TEMECULA", "mdr_report_key": "10002884", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ABBOTT VASCULAR, REG # 3005718570 (P099)", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189833140", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IN THE ABSENCE OF DEVICE RETURNED FOR ANALYSIS, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF HEMORRHAGE IS A KNOWN INHERENT RISK OF THE PROCEDURE. THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. IT WAS REPORTED THAT FORCE WAS USED IN ATTEMPT TO REMOVE THE DEVICE OF A SUTURE PLACEMENT IN RIGHT AXILLARY ARTERY. IT SHOULD BE NOTED THAT THE PROGLIDE INSTRUCTIONS FOR USE (IFU), STATES: DO NOT ADVANCE OR WITHDRAW THE PERCLOSE PROGLIDE SMC DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE PERCLOSE PROGLIDE SMC DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND / OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTION AND / OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR. ADDITIONALLY, THE IFU STATES: THE PERCLOSE PROGLIDE SMC SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY AND VEIN ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES. IN THIS CASE, IT IS UNKNOWN IF THE USE OUTSIDE THE INDICATED ANATOMY CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, THE FORCE USED WAS CIRCUMSTANTIAL DUE TO THE DIFFICULTY EXPERIENCED REMOVING THE DEVICE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL PROGLIDE DEVICE IS BEING FILED UNDER A SEPARATED MANUFACTURING REPORT NUMBER." }, { "mdr_text_key": "189833141", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT SUTURE PLACEMENT IN A RIGHT AXILLARY ARTERY WAS ATTEMPTED ON (B)(6) 2020, WITH TWO PROGLIDE DEVICES USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH PRIOR TO A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE WITH THE USE OF AN IMPELLA HEART DEVICE. REPORTEDLY, THE SUTURES OF THE FIRST PROGLIDE DEVICE WERE SUCCESSFULLY PRE-PLACED. WHEN THE ATTEMPT WAS MADE WITH THE SECOND PROGLIDE DEVICE, THERE WAS INTERACTION DURING INSERTION WITH THE PIG TAIL CATHETER SO THE PROGLIDE WAS NOT DEPLOYED AND WAS REMOVED. THE SHEATH WAS UPSIZED TO A 14F AND THE PCI PROCEDURE WAS COMPLETED. THE IMPELLA HEART PUMP WAS KEPT IN PLACE AND THE PATIENT WAS SENT TO THE FLOOR. ON (B)(6) 2020, THE PATIENT WAS BROUGHT BACK INTO THE CATH LAB. THE IMPELLA WAS REMOVED AND THE SUTURES OF THE PRE-PLACED PROGLIDE WERE THEN CINCHED DOWN TO CLOSE THE ACCESS SITE. THE DECISION WAS MADE TO USE AN ADDITIONAL PROGLIDE TO CLOSE THE ACCESS SITE. UPON ADVANCING THE PROGLIDE DEVICE INTO THE ANATOMY, BLOOD RETURN FROM THE MARKER LUMEN WAS DIFFICULT TO ACHIEVE; HOWEVER, WAS ULTIMATELY ABLE TO BE OBTAINED. REPORTEDLY, THE PROGLIDE DEVICE WAS DEPLOYED PER THE INSTRUCTIONS FOR USE (IFU); HOWEVER, THERE WAS RESISTANCE WHEN ATTEMPTING TO REMOVE THE DEVICE AFTER DEPLOYMENT. THE PROGLIDE BECAME STUCK AND WAS UNABLE TO BE REMOVED. IT WAS VERIFIED UNDER FLUOROSCOPY THAT THE FOOT WAS FULLY RETRACTED. AS THE PROGLIDE DEVICE COULD NOT BE REMOVED, THE PHYSICIAN DECIDED TO \"BREAK\" THE PROGLIDE HANDLE IN ATTEMPT TO FREE THE DEVICE. AS THIS WAS UNSUCCESSFUL IN REMOVING THE DEVICE, FORCE WAS USED TO ATTEMPT THE REMOVAL OF THE PROGLIDE AND THE PROGLIDE SEPARATED AT THE \"ELBOW\" WHERE THE FOOT CONNECTS WITH THE DEVICE. THE FOOT CAME OUT LEAVING THE HYDROPHILIC SHEATH AND THE \"SHELL\" OR COVERING OF THE FOOT IN THE ARTERY. ACCESS IN THE RIGHT SUBCLAVIAN (ABOUT AN INCH DISTAL TO THE AXILLARY ACCESS) WAS ACHIEVED TO ATTEMPT \"SNARING\" OF THE PORTION OF THE PROGLIDE LEFT IN THE ARTERY. A 14F SHEATH WAS PLACED IN THE RIGHT SUBCLAVIAN ACCESS SITE. A SNARE WAS USED TO ATTEMPT TO RECOVER THE PORTION OF THE PROGLIDE LEFT IN THE ARTERY. THIS WAS NOT SUCCESSFUL AT FIRST. THE OPERATORS UPSIZED THE 14F SHEATH IN THE RIGHT SUBCLAVIAN TO A 16F SHEATH. THE REST OF THE MATERIAL OF THE PROGLIDE WAS SUCCESSFULLY REMOVED FROM THE ARTERY USING A SNARE. BOTH THE RIGHT AXILLARY SHEATH AND THE RIGHT SUBCLAVIAN SHEATHS WHERE REMOVED. HEMOSTASIS WAS ACHIEVED BY PLACING A 7 X 59 BVX COVERED STENT ACROSS BOTH THE RIGHT AXILLARY AND RIGHT SUBCLAVIAN ARTERIOTOMIES. THIS WAS DONE VIA THE 7F SHEATH IN THE RIGHT COMMON FEMORAL ARTERY (RCFA). THE COVERED STENT WAS POST DILATED WITH A 10X40 BALLOON. A BALLOON PUMP WAS PLACED INTO THE PATIENT THROUGH THE 7F SHEATH OF THE RCFA AND SENT THE PATIENT BACK TO THE FLOOR. THE PATIENT REQUIRED A BLOOD TRANSFUSION DUE TO BLEEDING FROM THE PROGLIDE ISSUE. THE PATIENT WAS REPORTEDLY STABLE AFTER THE PROCEDURE AND THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS A REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CASHEL ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "925914628", "manufacturer_contact_exchange": "951", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "9616099-2020-03673", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200330", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "SDS AMIIA GENESIS 5.0X18 142", "generic_name": "CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "CORDIS CASHEL", "manufacturer_d_address_1": "CAHIR ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "CASHEL, TIPPERARY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "0000", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "0000", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200331", "model_number": "PG1850PMW", "catalog_number": "PG1850PMW", "lot_number": "17668372", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FGE", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2", "registration_number": [ "9616099" ], "fei_number": [ "3003528016" ] } } ], "product_problems": [ "Loss of or Failure to Bond", "Burst Container or Vessel", "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/01/2020", "manufacturer_contact_country": "", "date_changed": "20230614", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "GUIDING CATHETER SHEATHLESS PV ASAHI INTECC" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200507", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10002935", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200331", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "316667546", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A NON \u00bf CORDIS GUIDING CATHETER WAS DELIVERED TO THE LESION AND A 5.0 X 18 X 142 PALMAZ GENESIS STENT DELIVERY SYSTEM (SDS) WAS INFLATED. HOWEVER, PRESSURE COULD NOT BE APPLIED AT APPROXIMATELY 8ATM (EIGHT ATMOSPHERES); BALLOON RUPTURE WAS CONFIRMED. THE STENT WAS NOT DEPLOYED COMPLETELY, SO THE BALLOON COULD NOT BE REMOVED. THE DOCTOR CONSIDERED USING A SNARE TO REMOVE THE BALLOON, BUT IT WAS NOT PERFORMED BECAUSE OF POSSIBLE TISSUE DAMAGE. THE DOCTOR DECIDED FOR A SURGICAL REMOVAL AND SUCCEEDED IN REMOVING THE DEVICE. THE STATUS OF THE PATIENT HAS NOT BEEN CHANGED. THIS WAS A PEDIATRIC CARDIOLOGY CASE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17668372 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED \u00bfBALLOON BURST-AT/BELOW RBP\u00bf, \u00bfBALLOON-SDS WITHDRAWAL DIFFICULTY\u00bf AND \u00bfSTENT UNDEREXPANDED\u00bf COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, NOR WERE PROCEDURAL IMAGES PROVIDED FOR REVIEW. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS, ALTHOUGH UNKNOWN, MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT IS NOT INDICATED FOR EITHER PEDIATRIC OR CARDIOLOGY, THEREFORE THIS IS CONSIDERED OFF-LABEL USAGE. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE \u00bfINDICATION THE CORDIS PALMAZ GENESIS PERIPHERAL STENT ON CORDIS AMIIA .014\" DELIVERY SYSTEM IS INTENDED FOR USE IN THE TREATMENT OF ATHEROSCLEROTIC DISEASE OF PERIPHERAL ARTERIES BELOW THE AORTIC ARCH. CONTRAINDICATIONS INCLUDE, BUT MAY NOT BE LIMITED TO: PATIENTS WITH HIGHLY CALCIFIED LESIONS RESISTANT TO PTA. PRIOR TO STENTING, THE PALMAZ GENESIS PERIPHERAL STENT ON CORDIS AMIIA .014\" DELIVERY SYSTEM SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND INTEGRITY AND ENSURE THAT ITS SIZE AND SHAPE ARE SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED. DO NOT INDUCE A VACUUM ON THE DELIVERY SYSTEM PRIOR TO REACHING THE TARGET LESION. DO NOT ATTEMPT TO REMOVE OR READJUST THE STENT ON THE DELIVERY SYSTEM. SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING ADVANCEMENT OR REMOVAL OF THE STENT DELIVERY SYSTEM PRE-STENT IMPLANTATION AND BEFORE FULL EXPOSURE OF THE STENT, CAREFULLY ATTEMPT TO PULL THE UNEXPANDED STENT DELIVERY SYSTEM BACK THROUGH THE SHEATH INTRODUCER/GUIDING CATHETER. IF RESISTANCE IS FELT IN DOING SO, THE DELIVERY SYSTEM MUST BE REMOVED AS A SINGLE UNIT. WHEN REMOVING THE DELIVERY SYSTEM AS A SINGLE UNIT: DO NOT RETRACT THE DELIVERY SYSTEM INTO THE SHEATH INTRODUCER/GUIDING CATHETER. POSITION THE PROXIMAL BALLOON MARKER JUST DISTAL TO THE TIP OF THE SHEATH INTRODUCER/GUIDING CATHETER. ADVANCE THE GUIDEWIRE INTO THE ANATOMY AS FAR DISTALLY AS SAFELY POSSIBLE. SECURE THE STENT DELIVERY SYSTEM TO THE SHEATH INTRODUCER/GUIDING CATHETER; THEN REMOVE THE SHEATH INTRODUCER/GUIDING CATHETER AND STENT DELIVERY SYSTEM AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR STENT DELIVERY SYSTEM COMPONENTS SUCH AS THE BALLOON.\u00bf NEITHER THE PHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME." }, { "mdr_text_key": "190697399", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT." }, { "mdr_text_key": "190697400", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS REPORTED, A NON \u00bf CORDIS GUIDING CATHETER WAS DELIVERED TO THE LESION AND A 5.0 X 18 X 142 PALMAZ GENESIS STENT DELIVERY SYSTEM (SDS) WAS INFLATED. HOWEVER, PRESSURE COULD NOT BE APPLIED AT APPROXIMATELY 8 ATMOSPHERE (ATM); BALLOON RUPTURE WAS CONFIRMED. THE STENT WAS NOT DEPLOYED COMPLETELY, SO THE BALLOON COULD NOT BE REMOVED. THE DOCTOR CONSIDERED USING A SNARE TO REMOVE THE BALLOON, BUT IT WAS NOT PERFORMED BECAUSE OF POSSIBLE TISSUE DAMAGE. THE DOCTOR DECIDED FOR A SURGICAL REMOVAL AND SUCCEEDED IN REMOVING THE DEVICE. THE STATUS OF THE PATIENT HAS NOT BEEN CHANGED. THIS WAS A PEDIATRIC CARDIOLOGY CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/07/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2024168-2020-03932", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P070015", "date_of_event": "20131201", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM", "generic_name": "DRUG ELUTING CORONARY STENT DELIVERY SYSTEM", "manufacturer_d_name": "ABBOTT VASCULAR", "manufacturer_d_address_1": "26531 YNEZ RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMECULA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92591", "manufacturer_d_zip_code_ext": "4628", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "925914628", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "UNK XIENCE", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2024168" ], "fei_number": [ "2024168" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/20/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "2.75X28 XIENCE STENT" ], "sequence_number_outcome": [ "Hospitalization", " R", " S" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Myocardial Infarction", "Thrombosis" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003018", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "318778974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [ARTICLE CN-030866.PDF]." }, { "mdr_text_key": "189232141", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT DATES ESTIMATED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. ARTICLE TITLE: COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL." }, { "mdr_text_key": "189232142", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING A XIENCE STENT THAT WAS IMPLANTED IN THE MID TO DISTAL RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (MI). PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 2.5X20MM BALLOON AT 14 ATMOSPHERES (ATMS), AND THE 3.5X10MM XIENCE STENT WAS IMPLANTED AT 18 ATMS. POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.5X18MM BALLOON AT 14 ATMS. ANOTHER 2.75X28MM XIENCE STENT WAS IMPLANTED AT 14 ATMS. POST-DILATATION WAS PERFORMED AGAIN WITH AN UNSPECIFIED 2.5X15MM BALLOON AT 8 ATMS. THE PATIENT DEVELOPED THROMBOSIS AND A MI ON THE SAME DAY. TYPE OF TREATMENT WAS NOT SPECIFIED. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED \"COMPARISON OF AN EVEROLIMUS-ELUTING BIORESORBABLE SCAFFOLD WITH AN EVEROLIMUS-ELUTING METALLIC STENT IN ROUTINE PCI: THREE-YEAR CLINICAL OUTCOMES FROM THE AIDA TRIAL.\"" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2031527-2020-00143", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P040002", "date_of_event": "20200330", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "AFX", "generic_name": "BIFURCATED STENT GRAFT", "manufacturer_d_name": "ENDOLOGIX", "manufacturer_d_address_1": "2 MUSICK", "manufacturer_d_address_2": ",", "manufacturer_d_city": "IRVINE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92618", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92618", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20170131", "model_number": "BA25-110/I16-30", "catalog_number": "", "lot_number": "1226157-018", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Puncture/Hole", "Material Integrity Problem", "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/30/2020", "manufacturer_contact_country": "", "date_changed": "20230720", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "AFX VELA SUPRARENAL (LN 1229349011)" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "81 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aneurysm" ] } ], "distributor_city": "", "date_report": "20200330", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003021", "removal_correction_number": "Z-0006-2019", "number_devices_in_event": "", "date_manufacturer_received": "20200330", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319430948", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CLINICAL ASSESSMENT OF THE REPORTED EVENT WAS UNABLE TO BE COMPLETED DUE TO A LACK OF RECEIPT OF RELEVANT MEDICAL RECORDS AND/OR IMAGING. REQUESTS WERE MADE; HOWEVER, DENIED DUE TO REQUIREMENTS FOR PATIENT AUTHORIZATION. AS SUCH, EVENT DETERMINATION, OFF LABEL CONDITIONS, RELATED PATIENT HARMS AND PATIENT DISPOSITION COULD NOT BE ASSESSED. ALSO, A ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL AFX COMPLAINTS HAVING AN IDENTIFIED FAILURE MODE OF A TYPE IIIB ENDOLEAK. ENDOLOGIX IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS WITH THE INTENT OF REDUCING TYPE IIIB ENDOLEAK EVENTS; 1. UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND 2. UPDATES TO THE IFU AND ADDITIONAL PHYSICIAN TRAINING. THE CHANGE TO DURAPLY GRAFT MATERIAL AND THE IFU CHANGES WERE PUT IN PLACE (B)(6) 2014. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO DEVICE EVALUATION WAS COMPLETED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED; HOWEVER, IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED. DEVICE ITERATION IS AFX WITH STRATA. CORRECTIONS: B5: DESCRIBE EVENT OR PROBLEM - UPDATED. H6: RESULT CODE \u00bf REMOVE 3233. H6: CONCLUSION CODE \u00bf REMOVE 11." }, { "mdr_text_key": "319430949", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL EXTENSION. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED FOR ROUTINE FOLLOW UP WITH NOTED SAC ENLARGEMENT. THE PATIENT WAS REPORTEDLY STABLE. RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL EXTENSION. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT ANGIOGRAM CONFIRMED THERE WAS A TYPE IIIB ENDOLEAK. THE PATIENT WAS STABLE PRE AND POST PROCEDURE." }, { "mdr_text_key": "191988271", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH STRATA." }, { "mdr_text_key": "191988272", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL EXTENSION. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED FOR ROUTINE FOLLOW UP WITH NOTED SAC ENLARGEMENT. THE PATIENT WAS REPORTEDLY STABLE. RE-INTERVENTION WAS COMPLETED WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL EXTENSION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/13/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "92852630", "event_type": "Injury", "report_number": "3013164176-2020-00060", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P020004", "date_of_event": "20200403", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "9285263030", "noe_summarized": "1", "manufacturer_contact_l_name": "LOPEZ", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95050", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "928", "date_added": "20200427", "manufacturer_contact_f_name": "JENNA", "device_date_of_manufacturer": "20170909", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "W.L. GORE & ASSOCIATES", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "FLAGSTAFF", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200908", "model_number": "", "catalog_number": "PLC271000J", "lot_number": "17218357", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "3013164176" ], "fei_number": [ "3013164176" ] } } ], "product_problems": [ "Patient-Device Incompatibility" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "", "date_changed": "20210723", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9285", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "83 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200403", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "", "mdr_report_key": "10003061", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "95050", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL SILICON VALLEY B/P", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190314220", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). ACCORDING TO THE GORE\u00ae EXCLUDER\u00ae AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), INDICATIONS FOR USE OF THE CONTRALATERAL LEG ENDOPROSTHESIS COMPONENT INCLUDES APPROPRIATE ANATOMY INCLUDING, BUT NOT LIMITED TO, ILIAC ARTERY TREATMENT DIAMETER RANGE OF 8 \u00bf 25MM AND ILIAC DISTAL VESSEL SEAL ZONE LENGTH OF AT LEAST 10 MM." }, { "mdr_text_key": "190314221", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2018 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE\u00ae EXCLUDER\u00ae AAA ENDOPROSTHESES. ON (B)(6) 2020 THE PATIENT UNDERWENT A REINTERVENTION. DURING THE REINTERVENTION IT WAS NOTED THAT THE DISTAL DIAMETER OF THE PATIENT'S RIGHT COMMON ILIAC ARTERY HAD EXPANDED. THE CAUSE OF ILIAC ARTERY DILATION WAS NOT REPORTED. AN ADDITIONAL STENT GRAFT WAS DEPLOYED TO EXTEND THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT DOWN TO THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. THE ILIAC ARTERY DILATION WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2890 DE LA CRUZ BLVD.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "928", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3008011247-2020-00062", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P120006", "date_of_event": "20200330", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "OVATION IX", "generic_name": "ILIAC LIMB", "manufacturer_d_name": "ENDOLOGIX SANTA ROSA", "manufacturer_d_address_1": "3910 BRICKWAY BLVD", "manufacturer_d_address_2": ",", "manufacturer_d_city": "SANTA ROSA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95403", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95403", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20161005", "model_number": "TV-IL1418160-J", "catalog_number": "TV-IL1418160-J", "lot_number": "FS092115-29", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "M701TVIL1418160J1", "udi_public": "+M701TVIL1418160J1/$$3161005FS09211529U", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "3008011247" ], "fei_number": [ "3008011247" ] } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/30/2020", "manufacturer_contact_country": "", "date_changed": "20230720", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "ILIAC LIMB, LOT FS073115-31", " MAIN BODY, LOT FS091015-49", " POLYMER, LOT FF110215-01" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "83 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure of Implant" ] } ], "distributor_city": "", "date_report": "20200330", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003068", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200330", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319436254", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE WAS NOT RETURNED AS THE DEVICE REMAINS IMPLANTED THEREFORE NO EVALUATION WAS COMPLETED. THE TYPE IB ENDOLEAK EVENT IS UNCONFIRMED DUE TO A LACK OF RELEVANT MEDICAL RECORDS AND IMAGING. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS EVENT COULD NOT BE DETERMINED. THE PROCEDURE RELATED HARMS FOR THIS EVENT COULD NOT BE DETERMINED. THE FINAL PATIENT STATUS WAS NOT REPORTED. NO CONTRIBUTING FACTORS WERE IDENTIFIED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED HOWEVER IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS EVENT AND SIMILAR EVENTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED." }, { "mdr_text_key": "319436255", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK ON THE LEFT SIDE WAS IDENTIFIED BY A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THE PATIENT IS CURRENTLY BEING MONITORED WHILE AWAITING AN INTERVENTION. ADDITIONAL INFORMATION: RE-INTERVENTION COMPLETED ON (B)(6) 2020. THE PHYSICIAN ELECT TO IMPLANT AN OVATION IX ILIAC LIMB TO TREAT THIS EVENT. THE PATIENTS STATUS WAS NOT PROVIDED." }, { "mdr_text_key": "189769673", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "189769674", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK ON THE LEFT SIDE WAS IDENTIFIED BY A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA). THE PATIENT IS CURRENTLY BEING MONITORED WHILE AWAITING AN INTERVENTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/13/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2031527-2020-00141", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P040002", "date_of_event": "20200309", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "AFX", "generic_name": "BIFURCATED STENT GRAFT", "manufacturer_d_name": "ENDOLOGIX", "manufacturer_d_address_1": "2 MUSICK", "manufacturer_d_address_2": ",", "manufacturer_d_city": "IRVINE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92618", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92618", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20180711", "model_number": "BA22-90/I20-30", "catalog_number": "", "lot_number": "1371057021", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Material Puncture/Hole" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/30/2020", "manufacturer_contact_country": "", "date_changed": "20230728", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "INFRARENAL EXTENSION, LOT 1361056006" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Aneurysm", "Failure of Implant" ] } ], "distributor_city": "", "date_report": "20200330", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003075", "removal_correction_number": "Z-0006-2019", "number_devices_in_event": "", "date_manufacturer_received": "20200330", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319941888", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MANUFACTURING LOT REVIEW CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICES WERE NOT RETURNED AS THEY REMAIN IMPLANTED, AND THEREFORE NO SAMPLE EVALUATION WAS COMPLETED. A CLINICAL EVALUATION OF THE REPORTED EVENT COULD NOT BE COMPLETED DUE TO A LACK OF RECEIPT OF RELEVANT MEDICAL RECORDS AND/OR IMAGING; SEVERAL REQUESTS WERE MADE ON AND NO RESPONSE WAS RECEIVED. AS SUCH, THE EVENT DETERMINATION, OFF-LABEL CONDITIONS, RELATED PATIENT HARMS, AND PATIENT DISPOSITION COULD NOT BE ASSESSED WITH MEDICAL RECORDS/IMAGES. THE FINAL PATIENT STATUS WAS REPORTED IN GOOD CONDITION. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED; HOWEVER, IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED. DEVICE ITERATION IS AFX WITH DURAPLY." }, { "mdr_text_key": "190821655", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH DURAPL. DEVICE REMAINS IMPLANTED." }, { "mdr_text_key": "190821656", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE 3B ENDOLEAK WITH SAC GROWTH WAS REPORTED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER BIFURCATED STENT GRAFT TO RESOLVED THIS EVENT. THE PATIENT WAS REPORTED IN GOOD CONDITION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/16/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2031527-2020-00142", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P040002", "date_of_event": "20200402", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "AFX", "generic_name": "VELA SUPRARENAL", "manufacturer_d_name": "ENDOLOGIX", "manufacturer_d_address_1": "2 MUSICK", "manufacturer_d_address_2": ",", "manufacturer_d_city": "IRVINE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92618", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92618", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20150915", "model_number": "A34-34/C100-O20 V", "catalog_number": "", "lot_number": "1279539002", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00818009013651", "udi_public": "(01)00818009013651(17)150915", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Insufficient Information" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/03/2020", "manufacturer_contact_country": "", "date_changed": "20230711", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "AFX BIFURCATED STENT GRAFT (LN 1283102014)" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "80 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure of Implant", "Pain" ] } ], "distributor_city": "", "date_report": "20200403", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003079", "removal_correction_number": "Z-0006-2019", "number_devices_in_event": "", "date_manufacturer_received": "20200403", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "190301374", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH DURAPLY." }, { "mdr_text_key": "190301375", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A TYPE 1A ENDOLEAK WITH AORTIC NECK DILATION AND A TYPE 3A ENDOLEAK WERE IDENTIFIED. A RE-INTERVENTION WAS PERFORMED ON (B)(6) 2020. THE PHYSICIAN ELECTED TO IMPLANT AN AFX2 BIFURCATED STENT GRAFT, THREE AFX VELA SUPRARENAL STENT GRAFT EXTENSIONS, AND AN AFX VELA INFRARENAL STENT GRAFT EXTENSION TO RESOLVE THESE EVENTS." }, { "mdr_text_key": "318781643", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CLINICAL ASSESSMENT WAS COMPLETED BASED ON THE RECEIVED MEDICAL RECORDS. THE REPORTED SAC EXPANSION, TYPE 1A AND TYPE IIIA ENDOLEAK (AORTIC), AND SECONDARY ENDOVASCULAR PROCEDURE WAS CONFIRMED. THE CONTRIBUTING FACTORS FOR THE SAC EXPANSION WAS MOST LIKELY THE TYPE 1A AND TYPE IIIA ENDOLEAK. THE CONTRIBUTING FACTORS FOR THE TYPE 1A AND TYPE IIIA AORTIC COULD NOT BE DETERMINED DUE TO A LACK OF THE RELEVANT MEDICAL INFORMATION (PRE/POST-CT, OPERATIVE NOTES INITIAL IMPLANT); OF WHICH, SEVERAL REQUESTS WERE MADE WITH A RESPONSE OF DENIAL WAS RECEIVED DUE TO PATIENT AUTHORIZATION REQUIREMENTS. ADDITIONALLY, THE SUSPECTED AORTIC RUPTURE POST-SECONDARY ENDOVASCULAR PROCEDURE COULD NOT BE CONFIRMED. THE PROCEDURE RELATED HARMS IDENTIFIED FROM THE DISCHARGE SUMMARY WERE CARDIAC ARREST AND POSSIBLE AORTIC RUPTURE POST-SECONDARY ENDOVASCULAR PROCEDURE WHICH WAS SUCCESSFULLY TREATED. THE FINAL PATIENT STATUS WAS REPORTED TO BE DISCHARGED ONE DAY POST RE-INTERVENTION. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO DEVICE EVALUATION WAS COMPLETED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED; HOWEVER, IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED. DEVICE ITERATION IS AFX WITH DURAPLY. CORRECTIONS: H6: RESULT CODE \u00bf REMOVE 3233. H6: CONCLUSION CODE \u00bf REMOVE 11." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/13/2020" }, { "manufacturer_contact_zip_ext": "507", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "MR", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "2951 ISHIKAWA-CHO", "manufacturer_contact_pcity": "42642517", "event_type": "Malfunction", "report_number": "8010047-2020-02402", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200402", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "192-8", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "426425177", "noe_summarized": "1", "manufacturer_contact_l_name": "MATSUMOTO", "source_type": [ "HEALTH PROFESSIONAL", "USER FACI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "426", "date_added": "20200427", "manufacturer_contact_f_name": "KAZUTAKA", "device_date_of_manufacturer": "20200107", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200427", "brand_name": "EVIS LUCERA ELITE DUODENOVIDEOSCOPE", "generic_name": "DUODENOVIDEOSCOPE", "manufacturer_d_name": "OLYMPUS MEDICAL SYSTEMS CORP.", "manufacturer_d_address_1": "2951 ISHIKAWA-CHO", "manufacturer_d_address_2": "", "manufacturer_d_city": "HACHIOJI-SHI, TOKYO-TO", "manufacturer_d_state": "", "manufacturer_d_zip_code": "192-8", "manufacturer_d_zip_code_ext": "507", "manufacturer_d_country": "JA", "manufacturer_d_postal_code": "192-8507", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TJF-Q290V", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "FDT", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "8010047" ], "fei_number": [ "3002807795" ], "device_name": "Duodenoscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/26/2020", "manufacturer_contact_country": "JA", "date_changed": "20200622", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4264", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200618", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "HACHIOJI-SHI, TOKYO-TO", "mdr_report_key": "10003615", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200403", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "200850918", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED." }, { "mdr_text_key": "200850919", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE OF THE SUBJECT DEVICE, THE FLAP REMAINING IN THE CHANNEL FELL OFF IN THE PATIENT BODY. DETAILED INFORMATION IS AS FOLLOWS. THE FLAP FELL OFF WHEN THE TUBE STENT WAS PLACED USING THE SUBJECT DEVICE. DETAILS OF THE USED TUBE STENT ARE UNKNOWN, AND DETAILS OF THE CASE ARE ALSO UNKNOWN. WHEN USING THE SCOPE ON THE NEXT PATIENT AFTER REPROCESSING, THE FLAP REMAINED IN THE CHANNEL OF THE SCOPE AND FELL OFF IN THE BODY OF THE NEXT PATIENT. OMSC DON'T KNOW IF THE FLAP DROPPED OUT WAS COLLECTED. IT IS UNKNOWN WHETHER THE FLAPS HAD DROPPED OUT OF THE BODY WAS COLLECTED. BEDSIDE CLEANING AND WASHING MACHINE REPROCESSING ARE BEING CARRIED OUT AT THE FACILITY. DETAILS OF THE CLEANING BRUSH USED ARE UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT." }, { "mdr_text_key": "200855342", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. IT IS PRESUMED THAT THE REMAINING THIS FLAP IN THE INSTRUMENT CHANNEL AND THE DROPOUT INTO PATIENT'S BODY ARE CAUSED BY THE HANDLING OF THE TUBE STENT AND THE TUBE STENT ITSELF. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "192-8507", "manufacturer_contact_exchange": "426", "manufacturer_contact_pcountry": "081", "suppl_dates_fda_received": "06/18/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5005589", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080215", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20070110", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20080228", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080215", "brand_name": "EXPRESS 2 MONORAIL FOR DISTAL RIGHT CORONARY ARTERY", "generic_name": "NONE", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "*", "manufacturer_d_address_2": "", "manufacturer_d_city": "*", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "*", "manufacturer_d_postal_code": "", "device_operator": "0", "model_number": "EXPRESS2 MONORAIL", "catalog_number": "*", "lot_number": "*", "other_id_number": "*", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "", "date_changed": "20080228", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20080215", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening", " S" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080215", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1000372", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "22181626", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "BOSTON SCIENTIFIC EXPRESS 2 MONORAIL STENT USED CAUSED A LIFE THREATENING SITUATION WHICH NOW REQUIRES CONTINUED MEDICAL CARE AND DEATH EVENTUALLY. A CARDIAC CATH DONE, FOLLOWED BY OPEN HEART SURGERY, WITH MITRAL VALVE REPLACEMENT WITH A MECHANICAL PROSTHESIS,AND NOW A PACEMAKER WITH A DEFIBRILLATOR. KIDNEY FAILURE IS NOW PRESENT. THERE NEEDS TO BE A RECALL ON THIS PRODUCT OR ELSE MORE PEOPLE WILL DIE. MY REVIEW OF THE PAST RECALLS; MOST OF NOT MEANT MUCH BECAUSE THIS PRODUCT IS STILL CAUSING ALMOST DEATH AND RUINING PEOPLE'S LIVES. THE FDA SHOULD BE ASHAMED OF THEMSELVES!" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3007042319-2020-02993", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P100047", "date_of_event": "20161019", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "LITERATUR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP", "generic_name": "VENTRICULAR (ASSIST) BYPASS", "manufacturer_d_name": "HEARTWARE, INC.", "manufacturer_d_address_1": "14400 NW 60TH AVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MIAMI LAKES", "manufacturer_d_state": "FL", "manufacturer_d_zip_code": "33014", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "33014", "device_operator": "LAY USER/PATIENT", "model_number": "UNK", "catalog_number": "UNK", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DSQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "3007042319" ], "fei_number": [ "3007042319" ], "device_name": "Ventricular (Assist) Bypass", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Pumping Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/24/2020", "manufacturer_contact_country": "", "date_changed": "20230721", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Left Ventricular Dysfunction", "Heart Failure" ] } ], "distributor_city": "", "date_report": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003762", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200427", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "319499345", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: PUMPS WITH UNKNOWN SERIAL NUMBERS AND OUTFLOW GRAFTS WITH UNKNOWN LOT NUMBERS WERE NOT RETURNED FOR EVALUATION. THE REPORTED LOW FLOW EVENTS WERE CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED A SUSTAINED DECREASE IN POWER CONSUMPTION AND ESTIMATED FLOWS BEGINNING ON (B)(6) 2016. THE ALARM LOG FILE WAS NOT AVAILABLE FOR ANALYSIS. OF NOTE, VISUAL EVIDENCE PROVIDED REVEALED AN OBSTRUCTION OF THE OUTFLOW GRAFT DUE TO EXTERNAL COMPRESSION FROM ACCUMULATED MATERIAL THAT WAS TRAPPED BETWEEN THE OUTFLOW GRAFT AND AN ADDITIONAL SURROUNDING STENT PLACED BY THE SURGEON AT IMPLANT. THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION OR PERFORMANCE ISSUE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOW FLOW EVENTS CAN BE ATTRIBUTED TO COMPRESSION OF THE OUTFLOW GRAFTS FROM A FOREIGN STENT SURROUNDING THE OUTFLOW GRAFTS PLACED DURING IMPLANT. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS INCLUDE THE PATIENTS\u00bf PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENTS\u00bf COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM \u00bf OUTFLOW GRAFT H3: YES H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 180 H6: FDA CONCLUSION CODE(S): 19 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "196769667", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANS PLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: PERCUTANEOUS INTERVENTION FOR LEFT VENTRICULAR ASSIST DEVICE OUTFLOW OBSTRUCTION. HEART, LUNG AND CIRCULATION, MARCH 2020; 29(3):E25-E27. DOI: 10.1016/J.HLC.2019.08.016 ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM \u00bf OUTFLOW GRAFT. MODEL #: UNK, CATALOG #: UNK, EXPIRATION DATE: UNK, LOT#: UNK, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: UNK. LABELED FOR SINGLE USE: YES. (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE CAUSE OF THE ADVERSE EVENT AND DISPOSITION OF THE MEDICAL DEVICE, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE SENT. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "196769668", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING VENTRICULAR ASSIST DEVICES (VADS). THE ARTICLE DISCUSSED PERCUTANEOUS INTERVENTION FOR OUTFLOW GRAFT OBSTRUCTION. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THERE WERE THREE PATIENTS ON VAD SUPPORT WHO EXPERIENCED OUTFLOW GRAFT (OFG) STENOSIS/OBSTRUCTION DUE TO EXTERNAL COMPRESSION, CONFIRMED BY CHEST COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS). THEY PRESENTED TO THE HOSPITAL IN DECOMPENSATED HEART FAILURE, WITH A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWING LEFT VENTRICULAR DILATATION. THE VAD PUMPS EXHIBITED DECREASED FLOWS, POWER CONSUMPTION AND PULSATILITY. PERCUTANEOUS BALLOON ANGIOPLASTY WAS PERFORMED WHICH IMMEDIATELY RELIEVED THE STENOSIS AND RESTORED FLOW. TWO PATIENTS UNDERWENT OFG STENTING TO ENSURE LUMEN PATENCY. THE ONE PATIENT WHO DID NOT UNDERGO OFG STENTING RE-DEVELOPED OFG OBSTRUCTION A FEW WEEKS LATER AND REQUIRED SURGICAL PUMP EXCHANGE. ONE PATIENT LATER UNDERWENT CARDIAC TRANSPLANTATION AND UPON VAD EXPLANTATION, IT WAS NOTED A GELATINOUS EXUDATE ENCASED THE OFG, LIKELY CAUSING THE STENOSIS/OBSTRUCTION. THE STATUS/LOCATION OF THE VADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/27/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "NATIONAL TECHNOLOGY PARK", "event_location": "HOSPITAL", "report_to_fda": "N", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "NATIONAL TECHNOLOGY PARK", "manufacturer_g1_city": "LIMERICK", "manufacturer_contact_address_1": "O HALLORAN ROAD", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "3001845648-2020-00265", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "K851962", "date_of_event": "20200327", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "RYAN", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "date_facility_aware": "20200327", "manufacturer_g1_state": "", "reporter_country_code": "KR", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "HEATHER", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ZIMMON BILIARY STENT", "generic_name": "FGE CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "COOK IRELAND LTD", "manufacturer_d_address_1": "O HALLORAN ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "LIMERICK", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "ZSO-7-5", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FGE", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2" } } ], "product_problems": [ "Material Twisted/Bent" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "", "date_changed": "20200428", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200330", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "LIMERICK", "mdr_report_key": "10003941", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200330", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "COOK IRELAND LTD", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "199045165", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE EVALUATION: THE ZSO-7-5 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION \u00bf N/A. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ZSO-7-5 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. AS PER STEP 1.3 IN FINAL QUALITY CONTROL, FQC0144 THE MANUFACTURING TEAM MEMBER (MTM) IS INSTRUCTED TO \"INSPECT FOR DEBRIS IN OR ON PRODUCT, KINKS\". ADDITIONALLY, IN STEP 1.10 OF FQC0144, THE MANUFACTURING TEAM MEMBER (MTM) IS INSTRUCTED TO \u00bfVERIFY SIZE OF WIRE GUIDE BEFORE EACH USE. INSERT WIRE GUIDE INTO BOTH ENDS OF STENT.\u00bf IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045-7) STATES THE FOLLOWING: \u00bfVISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.\u00bf \u00bfCARE MUST BE EXERCISED WHEN STRAIGHTENING THE PIGTAIL CURLS IN ORDER TO AVOID KINKING OR BREAKING THE STENT.\u00bf IT SHOULD ALSO BE NOTED THAT THE PRODUCT LABEL INSTRUCTS THE USER THAT A 0.035\u00bf WIRE GUIDE SHOULD BE USED WITH THE STENT. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE PRODUCT LABEL. IMAGE REVIEW \u00bf N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE DEVICE. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035\u00bf WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035\u00bf WIRE GUIDE. AS THE SMALLER DIAMETER 0.025\u00bf WIRE GUIDE OCCUPIES LESS SPACE IN THE LUMEN OF THE PIGTAIL STENT IT IS LIKELY THAT THE EXTENT OF THE CURVATURE OF THE PIGTAIL WILL BE GREATER WHEN A 0.025. AS PER ADDITIONAL INFORMATION RECEIVED THE USER USED A 0.025\" WIRE GUIDE. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS." }, { "mdr_text_key": "199045166", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WHEN THE NURSE TRIED TO INSERT THE STENT IN, THE PIGTAIL OF THE STENT WAS KINKED AND THE G/W COULD NOT PASS. SO THEY USED ANOTHER STENT TO FINISH THE CASE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "O HALLORAN ROAD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_contact_pcity": "09170809", "event_type": "Injury", "report_number": "9612164-2020-01692", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P100021", "date_of_event": "20200330", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "091708096", "noe_summarized": "1", "manufacturer_contact_l_name": "SWEENEY", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "CH", "manufacturer_contact_area_code": "091", "date_added": "20200428", "manufacturer_contact_f_name": "ALISON", "device_date_of_manufacturer": "20191017", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "ENDURANT ILIAC STENT GRAFT", "generic_name": "SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211016", "model_number": "ENLW1616C95EE", "catalog_number": "ENLW1616C95EE", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200330", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Activation, Positioning or Separation Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/12/2020", "manufacturer_contact_country": "", "date_changed": "20210723", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "0917", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "71 YR", "patient_sex": "", "patient_weight": "78", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200617", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "GALWAY", "mdr_report_key": "10003961", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200330", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC IRELAND", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "196960423", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVALUATION SUMMARY THE REPORTED INABILITY TO DEPLOY EVENT COULD NOT BE CONFIRMED FROM THE FILMS PROVIDED; THEREFORE THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. PROCEDURAL ANGIOGRAM IMAGES SHOWING ATTEMPTS TO DEPLOY THE DEVICE WERE NOT PROVIDED. THE LOCATION WHERE THIS LIMB WAS ATTEMPTED TO BE IMPLANTED (LEFT OR RIGHT ILIAC) IS ALSO UNKNOWN. IT IS LIKELY THAT THE PATIENTS ANATOMY (EXTREMELY TORTUOUS AND CALCIFIED ILIAC ARTERIES), OR OTHER UNKNOWN ANATOMICAL OR PROCEDURAL ISSUE(S), MAY HAVE CONTRIBUTED TO INABILITY IN DEPLOYING THE DEVICE IN THE INTENDED LOCATION. THE DELIVERY SYSTEM IS NOT RETURNING SO ANALYSIS OF THE DEVICE FOR POTENTIAL ISSUES WILL NOT BE POSSIBLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "196960424", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ENDURANT BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 74.1MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE OUTER SHEATH OF THE STENT GRAFT LIMB AND THE STENT COULD NOT BE OPENED TOGETHER WHEN CONNECTING TO THE 161695 CONTRALATERAL LEG. THE PHYSICIAN THEN REMOVED IT FROM THE BODY THROUGH THE GUIDE WIRE AND IMPLANTED ANOTHER STENT INSTEAD -ENLW1616C80EE AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE." }, { "mdr_text_key": "201271350", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PHOTO EVALUATION SUMMARY ONE PHOTO CAPTURING A SECTION OF THE GRAFT AND GRAFT COVER WAS RECEIVED FROM THE ACCOUNT. TWO (2) SLIGHT KINKS WERE VISIBLE ON THE GRAFT COVER. THERE WAS BLOOD PRESENT IN THE GRAFT COVER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "PARKMORE BUSINESS PARK WEST", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "091", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "06/17/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_contact_pcity": "09170809", "event_type": "Death", "report_number": "9612164-2020-01693", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "K050038", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "091708096", "noe_summarized": "1", "manufacturer_contact_l_name": "SWEENEY", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "091", "date_added": "20200428", "manufacturer_contact_f_name": "ALISON", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "RELIANT BALLOON", "generic_name": "CATHETER, PERCUTANEOUS", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "AB46", "catalog_number": "AB46", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DQY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ], "device_name": "Catheter, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/18/2020", "manufacturer_contact_country": "", "date_changed": "20200617", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "0917", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200612", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "GALWAY", "mdr_report_key": "10003981", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC IRELAND", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "197668418", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT DURING THE USE OF THE RELIANT FOR EXPANSION OF VASCULAR PROTHESIS, THE PHYSICIAN ALSO ENCOUNTERED ANEURYSM RUPTURES (THESE WERE PATIENTS WITH CALCIFIED VESSELS). THE PHYSICIAN FOUND THESE EVENTS VERY CONCERNING, SOMEWHAT CONCERNING AND NOT AT ALL CONCERNING. THESE EVENTS WERE FOUND TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189136345", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189136346", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC CONDUCTED A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY TO SEEK OUT POTENTIAL NEW RISKS AND ASSESS PERFORMANCE OF THE RELIANT DEVICE. THE EXACT SIZE OF THE DEVICE IS UNKNOWN. SURVEY RESULTS FROM AN INTERVENTIONAL CARDIOLOGIST IN PRACTICE 21 YEARS, WHO HAS USED THE RELIANT DEVICE FOR EXPANSION OF VASCULAR PROSTHESES 600 TIMES IN TOTAL OVER THE LAST 15 MONTHS AND 300 TIMES IN THE LAST 12 MONTHS AND FOR TEMPORARY OCCLUSION OF LARGE VESSELS 400 TIMES IN TOTAL OVER THE LAST 15 MONTHS AND 200 TIMES IN THE LAST 12 MONTHS. DURING USE OF THE RELIANT FOR EXPANSION OF VASCULAR PROSTHESES (ASSISTING IN THE EXPANSION OF SELF-EXPANDING STENT GRAFTS), THE FOL LOWING COMPLICATIONS WERE ENCOUNTERED; HEMATOMA (VERY OLD PATIENTS WITH VERY FRAGILE CASE OR DIFFICULT PUNCTURE), VESSEL PERFORATION OR DISSECTION (VERY OLD PATIENTS), STROKE (PATIENT WITH A LOT OF ARTERIOSCLEROSIS), HAEMORRHAGE(ANTICOAGULATED OR VERY OLD PATIENTS), DEATH (VERY DILATED ANEURYSMS), BALLOON CATCHING INSIDE OF GRAFT DURING CATHETER MOVEMENT (COMPLEX PROCEDURE) AND BALLOON RUPTURE (A LOT OF CALCIUM IN THE VESSEL). THE PHYSICIAN FOUND THE DEATH EVENTS VERY CONCERNING, HEMATOMA EVENTS WERE SOMEWHAT OR NOT AT ALL CONCERNING, VESSEL PERFORATION OR DISSECTION, STROKE, BALLOON CATCHING INSIDE OF GRAFT DURING CATHETER MOVEMENT AND BALLOON RUPTURE VERY OR SOMEWHAT CONCERNING AND THE HAEMORRHAGE EVENTS TO BE VERY, SOMEWHAT OR NOT AT ALL CONCERNING. ALL OF THE ADVERSE EVENTS AND THE BALLOON CATCHING AND BALLOON RUPTURE EVENTS WERE REPORTED TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION, THE DEATH EVENTS WERE REPORTED TO BE NOT RELATED TO THE DEVICE. DURING USE OF THE RELIANT FOR TEMPORARY OCCLUSION OF LARGE VESSELS, THE FOLLOWING COMPLICATIONS WERE ENCOUNTERED; VESSEL PERFORATION OR DISSECTION (VERY OLD, COMPLETE ANATOMY), STROKE (SIGNIFICANT ARTERIOSCLEROSIS), ANEURYSM RUPTURE (VERY DILATED ANEURYSM), DEATH (SIGNIFICANT COMORBIDITY), STENT GRAFT MIGRATION CAUSED BY BALLOON CATHETER DEVICE (SIGNIFICANT CALCIFICATION). THE PHYSICIAN FOUND THE DEATH EVENTS VERY CONCERNING, VESSEL PERFORATION OR DISSECTION, ANEURYSM EVENTS VERY, SOMEWHAT OR NOT AT ALL CONCERNING, STROKE, STENT GRAFT MIGRATION VERY OR SOMEWHAT CONCERNING. ALL OF THE EVENTS WERE REPORTED TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION. OF THE ABOVE COMPLICATIONS REPORTED, SOME OF THESE ARE LISTED AS HAVING BEEN REPORTED TO MEDTRONIC PREVIOUSLY. DUE TO LIMITED INFORMATION THESE ARE INCLUDED IN REPORTING. NO FURTHER INFORMATION HAS OR WILL BE PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "PARKMORE BUSINESS PARK WEST", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "091", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "06/12/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9612164-2020-01694", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "K050038", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "RELIANT BALLOON", "generic_name": "CATHETER, PERCUTANEOUS", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "AB46", "catalog_number": "AB46", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DQY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/18/2020", "manufacturer_contact_country": "", "date_changed": "20230616", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Stroke/CVA", "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Perforation", "Rupture" ] } ], "distributor_city": "", "date_report": "20200615", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003991", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "317317806", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "B:5 ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT DURING THE USE OF THE RELIANT FOR EXPANSION OF VASCULAR PROTHESIS, THE PHYSICIAN ALSO ENCOUNTERED ANEURYSM RUPTURES (THESE WERE PATIENTS WITH CALCIFIED VESSELS). THE PHYSICIAN FOUND THESE EVENTS VERY CONCERNING, SOMEWHAT CONCERNING AND NOT AT ALL CONCERNING. THESE EVENTS WERE FOUND TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION. H:6 UPDATED MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "196863876", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "196863877", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC CONDUCTED A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY TO SEEK OUT POTENTIAL NEW RISKS AND ASSESS PERFORMANCE OF THE RELIANT DEVICE. THE EXACT SIZE OF THE DEVICE IS UNKNOWN. SURVEY RESULTS FROM AN INTERVENTIONAL CARDIOLOGIST IN PRACTICE 21 YEARS, WHO HAS USED THE RELIANT DEVICE FOR EXPANSION OF VASCULAR PROSTHESES 600 TIMES IN TOTAL OVER THE LAST 15 MONTHS AND 300 TIMES IN THE LAST 12 MONTHS AND FOR TEMPORARY OCCLUSION OF LARGE VESSELS 400 TIMES IN TOTAL OVER THE LAST 15 MONTHS AND 200 TIMES IN THE LAST 12 MONTHS. DURING USE OF THE RELIANT FOR EXPANSION OF VASCULAR PROSTHESES (ASSISTING IN THE EXPANSION OF SELF-EXPANDING STENT GRAFTS), THE FOLLOWING COMPLICATIONS WERE ENCOUNTERED; HEMATOMA (VERY OLD PATIENTS WITH VERY FRAGILE CASE OR DIFFICULT PUNCTURE), VESSEL PERFORATION OR DISSECTION (VERY OLD PATIENTS), STROKE (PATIENT WITH A LOT OF ARTERIOSCLEROSIS), HAEMORRHAGE(ANTICOAGULATED OR VERY OLD PATIENTS), DEATH (VERY DILATED ANEURYSMS), BALLOON CATCHING INSIDE OF GRAFT DURING CATHETER MOVEMENT (COMPLEX PROCEDURE) AND BALLOON RUPTURE (A LOT OF CALCIUM IN THE VESSEL). THE PHYSICIAN FOUND THE DEATH EVENTS VERY CONCERNING, HEMATOMA EVENTS WERE SOMEWHAT OR NOT AT ALL CONCERNING, VESSEL PERFORATION OR DISSECTION, STROKE, BALLOON CATCHING INSIDE OF GRAFT DURING CATHETER MOVEMENT AND BALLOON RUPTURE VERY OR SOMEWHAT CONCERNING AND THE HAEMORRHAGE EVENTS TO BE VERY, SOMEWHAT OR NOT AT ALL CONCERNING. ALL OF THE ADVERSE EVENTS AND THE BALLOON CATCHING AND BALLOON RUPTURE EVENTS WERE REPORTED TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION, THE DEATH EVENTS WERE REPORTED TO BE NOT RELATED TO THE DEVICE. DURING USE OF THE RELIANT FOR TEMPORARY OCCLUSION OF LARGE VESSELS, THE FOLLOWING COMPLICATIONS WERE ENCOUNTERED; VESSEL PERFORATION OR DISSECTION (VERY OLD, COMPLETE ANATOMY), STROKE (SIGNIFICANT ARTERIOSCLEROSIS), ANEURYSM RUPTURE (VERY DILATED ANEURYSM), DEATH (SIGNIFICANT COMORBIDITY), STENT GRAFT MIGRATION CAUSED BY BALLOON CATHETER DEVICE (SIGNIFICANT CALCIFICATION). THE PHYSICIAN FOUND THE DEATH EVENTS VERY CONCERNING, VESSEL PERFORATION OR DISSECTION, ANEURYSM EVENTS VERY, SOMEWHAT OR NOT AT ALL CONCERNING, STROKE, STENT GRAFT MIGRATION VERY OR SOMEWHAT CONCERNING. ALL OF THE EVENTS WERE REPORTED TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION. OF THE ABOVE COMPLICATIONS REPORTED, SOME OF THESE ARE LISTED AS HAVING BEEN REPORTED TO MEDTRONIC PREVIOUSLY. DUE TO LIMITED INFORMATION THESE ARE INCLUDED IN REPORTING. NO FURTHER INFORMATION HAS OR WILL BE PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/15/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_contact_pcity": "09170809", "event_type": "Malfunction", "report_number": "9612164-2020-01695", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "K050038", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "091708096", "noe_summarized": "1", "manufacturer_contact_l_name": "SWEENEY", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SP", "manufacturer_contact_area_code": "091", "date_added": "20200428", "manufacturer_contact_f_name": "ALISON", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "RELIANT BALLOON", "generic_name": "CATHETER, PERCUTANEOUS", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "AB46", "catalog_number": "AB46", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DQY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ], "product_problems": [ "Burst Container or Vessel", "Migration or Expulsion of Device", "Difficult to Remove" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/18/2020", "manufacturer_contact_country": "", "date_changed": "20200623", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "0917", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200615", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "GALWAY", "mdr_report_key": "10003995", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC IRELAND", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "202260112", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT DURING THE USE OF THE RELIANT FOR EXPANSION OF VASCULAR PROTHESIS, THE PHYSICIAN ALSO ENCOUNTERED ANEURYSM RUPTURES (THESE WERE PATIENTS WITH CALCIFIED VESSELS). THE PHYSICIAN FOUND THESE EVENTS VERY CONCERNING, SOMEWHAT CONCERNING AND NOT AT ALL CONCERNING. THESE EVENTS WERE FOUND TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION. METHOD/RESULT CONCLUSION UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "192164261", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "192164262", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC CONDUCTED A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY TO SEEK OUT POTENTIAL NEW RISKS AND ASSESS PERFORMANCE OF THE RELIANT DEVICE. THE EXACT SIZE OF THE DEVICE IS UNKNOWN. SURVEY RESULTS FROM AN INTERVENTIONAL CARDIOLOGIST IN PRACTICE 21 YEARS, WHO HAS USED THE RELIANT DEVICE FOR EXPANSION OF VASCULAR PROSTHESES 600 TIMES IN TOTAL OVER THE LAST 15 MONTHS AND 300 TIMES IN THE LAST 12 MONTHS AND FOR TEMPORARY OCCLUSION OF LARGE VESSELS 400 TIMES IN TOTAL OVER THE LAST 15 MONTHS AND 200 TIMES IN THE LAST 12 MONTHS. DURING USE OF THE RELIANT FOR EXPANSION OF VASCULAR PROSTHESES (ASSISTING IN THE EXPANSION OF SELF-EXPANDING STENT GRAFTS), THE FOL LOWING COMPLICATIONS WERE ENCOUNTERED; HEMATOMA (VERY OLD PATIENTS WITH VERY FRAGILE CASE OR DIFFICULT PUNCTURE), VESSEL PERFORATION OR DISSECTION (VERY OLD PATIENTS), STROKE (PATIENT WITH A LOT OF ARTEROSCLEROSIS), HAEMORRHAGE(ANTICOAGULATED OR VERY OLD PATIENTS), DEATH (VERY DILATED ANEURYSMS), BALLOON CATCHING INSIDE OF GRAFT DURING CATHETER MOVEMENT (COMPLEX PROCEDURE) AND BALLOON RUPTURE (A LOT OF CALCIUM IN THE VESSEL). THE PHYSICIAN FOUND THE DEATH EVENTS VERY CONCERNING, HEMATOMA EVENTS WERE SOMEWHAT OR NOT AT ALL CONCERNING, VESSEL PERFORATION OR DISSECTION, STROKE, BALLOON CATCHING INSIDE OF GRAFT DURING CATHETER MOVEMENT AND BALLOON RUPTURE VERY OR SOMEWHAT CONCERNING AND THE HAEMORRHAGE EVENTS TO BE VERY, SOMEWHAT OR NOT AT ALL CONCERNING. ALL OF THE ADVERSE EVENTS AND THE BALLOON CATCHING AND BALLOON RUPTURE EVENTS WERE REPORTED TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION, THE DEATH EVENTS WERE REPORTED TO BE NOT RELATED TO THE DEVICE. DURING USE OF THE RELIANT FOR TEMPORARY OCCLUSION OF LARGE VESSELS, THE FOLLOWING COMPLICATIONS WERE ENCOUNTERED; VESSEL PERFORATION OR DISSECTION (VERY OLD, COMPLETE ANATOMY), STROKE (SIGNIFICANT ARTEROSCLEROSIS), ANEURYSM RUPTURE (VERY DILATED ANEURYSM), DEATH (SIGNIFICANT COMORBIDITY), STENT GRAFT MIGRATION CAUSED BY BALLOON CATHETER DEVICE (SIGNIFICANT CALCIFICATION). THE PHYSICIAN FOUND THE DEATH EVENTS VERY CONCERNING, VESSEL PERFORATION OR DISSECTION, ANEURYSM EVENTS VERY, SOMEWHAT OR NOT AT ALL CONCERNING, STROKE, STENT GRAFT MIGRATION VERY OR SOMEWHAT CONCERNING. ALL OF THE EVENTS WERE REPORTED TO BE RELATED TO THE DEVICE ON AT LEAST ONE OCCASION. OF THE ABOVE COMPLICATIONS REPORTED, SOME OF THESE ARE LISTED AS HAVING BEEN REPORTED TO MEDTRONIC PREVIOUSLY. DUE TO LIMITED INFORMATION THESE ARE INCLUDED IN REPORTING. NO FURTHER INFORMATION HAS OR WILL BE PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "PARKMORE BUSINESS PARK WEST", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "091", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "06/15/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "9612164-2020-01696", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P160043", "date_of_event": "20200424", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "RESOLUTE ONYX RX", "generic_name": "STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210908", "model_number": "", "catalog_number": "RONYX20022X", "lot_number": "0009911287", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200512", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ] } } ], "product_problems": [ "Device Damaged by Another Device", "Device Dislodged or Dislocated", "Material Deformation" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/01/2020;06/22/2020", "manufacturer_contact_country": "", "date_changed": "20230714", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury" ] } ], "distributor_city": "", "date_report": "20200630", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10004044", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200424", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189165334", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189165335", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS REPORTED THAT THE STENT DETACHED FROM THE BALLOON IN VIVO. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED." }, { "mdr_text_key": "317309519", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS STATED THAT THE STENT GOT 'HUNG UP' ON A PREVIOUSLY IMPLANTED STENT AT THE OSTIA OF ANOTHER VESSEL. RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING WITHDRAWAL OF THE DEVICE. AN ATTEMPT WAS MADE TO TRAP THE DISLODGED STENT USING A BALLOON BUT WERE ONLY ABLE TO PULL BACK THE DISLODGED STENT TO THE AORTA. STILL IMAGES WERE PROVIDED FOR REVIEW. THE IMAGES ARE OF A DISLODGED STENT ATTACHED TO A SNARE DEVICE. THE SNARE DEVICE IS LOADED THROUGH A GUIDE CATHETER. EXTENSIVE DEFORMATION WAS EVIDENT TO THE ENTIRE STENT. 3 VIDEOS WERE ALSO PROVIDED FROM THE PROCEDURE. ONE SHOWS A DISLODGED STENT. THIS DISLODGED STENT IS INSIDE THE PREVIOUSLY DEPLOYED STENT AT THE OSTIUM OF THE VESSEL. THE SECOND SHOWS A SEVERELY ELONGATED DAMAGED STENT BEING SNAGGED WITH A SNARE DEVICE. THE THIRD SHOWS A GUIDE CATHETER AND A DISLODGED STENT. CORRECTION: ADVERSE EVENT, PRODUCT PROBLEM SELECTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY \u00bfDEFECTS\u00bf OR HAS \u00bfMALFUNCTIONED\u00bf. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "197166196", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PRODUCT ANALYSIS: THE DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS. THE DISLODGED STENT WAS ATTACHED TO A SNARE THAT WAS LOADED INTO A NON-MEDTRONIC GUIDE CATHETER. THERE WAS A NON-MEDTRONIC Y-ADAPTER ATTACHED TO THE GUIDE CATHETER. SEVERE STR ETCHING AND DEFORMATION WERE EVIDENT TO THE DISLODGED STENT. PRODUCT ANALYSIS: VIDEOS WERE PROVIDED FROM THE PROCEDURE. IMAGE 1 SHOWS A DISLODGED STENT. THIS DISLODGED STENT IS INSIDE THE PREVIOUSLY DEPLOYED STENT AT THE OSTIUM OF THE VESSEL. IMAGE 2 SHOWS A SEVERELY ELONGATED DAMAGED STENT BEING SNAGGED WITH A SNARE DEVICE. IMAGE 3 SHOWS A GUIDE CATHETER AND A DISLODGED STENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/27/2020;06/30/2020" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00497", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20060425", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Study", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20040801", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20050106", "model_number": "3.5 X 16 MM", "catalog_number": "H7493897016350", "lot_number": "6865091", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080201", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000407", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080201", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "17234879", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION: THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH, HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." }, { "mdr_text_key": "17251428", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CLINICAL STUDY. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT HAD A TARGET VESSEL REVASCULARIZATION (TVR). THE PT PRESENTED TO THE INDEX PROCEDURE WITH CHEST PAIN. INITIAL ECG AND CARDIAC ENZYMES WERE NEGATIVE AND THE PT WAS ADMITTED FOR OBSERVATION WITH PLANS FOR STRESS TESTING THE FOLLOWING DAY. SUBSEQUENTLY, THE PT'S TROPONIN WAS ELEVATED AND HE WAS ADMITTED FOR CARDIAC CATHETERIZATION. TARGET LESION 1 WAS IDENTIFIED IN THE SVG TO 3RD DIAGONAL (DIAG3) WITH 70% STENOSIS, 50 MM LONG, AND A 3.0MM DIAMETER. TARGET LESION 1 WAS TREATED WITH DIRECT PLACEMENT OF TWO OVERLAPPING 3.0 X 32 MM TAXUS EXPRESS2 STENTS. RESIDUAL STENOSIS WAS 0%. TARGET LESION 2 WAS IDENTIFIED IN THE NATIVE DIAG3, AT THE INSERTION POINT OF THE SVG, WITH 90% STENOSIS, 6 MM LENGTH AND A 2.5 MM DIAMETER. TARGET LESION 2 WAS TREATED WITH PRE-DILATION, THEN PLACEMENT OF ANOTHER MFRS 2.0 X 23 STENT AND A MINIMALLY OVERLAPPING 2.5 X 8 MM TAXUS EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. THE PT RETURNED 6 DAYS LATER FOR A STAGED PROCEDURE. TARGET LESION 1 WAS IDENTIFIED IN THE SVG TO THE RCA WITH 70%, 12 MM LENGTH AND 3.5 MM WIDTH. TARGET LESION 1 WAS TREATED WITH DIRECT PLACEMENT OF A 3.5 X 16 MM TAXUS EXPRESS2 STENT. SUBSEQUENTLY, THE PT DEVELOPED MILD CHEST PAIN AND HAD MILD ST SEGMENT ELEVATION, WHICH ALL ABATED AT THE COMPLETION OF THE PROCEDURE. IT WAS NOTED THAT THE EMBOLIC PROTECTION DEVICE WAS FOUND TO HAVE A MODERATE AMOUNT OF ATHEROSCLEROTIC DEBRIS RETRIEVED. RESIDUAL STENOSIS WAS 0%. IN 04/2006, THE PT WAS ADMITTED DUE TO CHEST PAIN THAT WAS NOT RELIEVED BY NITROGLYCERIN. IT WAS NOTED THAT THE PT HAD HAD LITTLE IMPROVEMENT IN HIS ANGINAL SYMPTOMS SINCE HIS CABG REDO IN 03/2006. THE PT'S \"ENZYMES\" WERE NOTED TO BE \"MARGINALLY ELEVATED AT 0.04 AND 0.06\". ONE DAY LATER, A \"POOR QUALITY\" STRESS TEST REVEALED PARTIALLY REVERSIBLE DEFECTS INVOLVING THE MID INFERIOR WALL, APEX, AND INFERIOR APICAL WALL. THERE WAS MILD LEFT VENTRICULAR ENLARGEMENT WITH LVEF 43% AND SEVERE INFERIOR APICAL WALL HYPOKINESIS. AT 526 DAYS POST ARRIVE2 ENROLLMENT, THE PT UNDERWENT PCI OF THE RADIAL ARTERY GRAFT TO THE RCA AND THE NATIVE LAD. THE OSTIUM OF THE RADIAL ARTERY GRAFT TO THE \"RCA\" WAS TREATED WITH DIRECT PLACEMENT OF ANOTHER MFRS 3.5 X 13 MM STENT, WHICH RESULTED IN 10% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE DISTAL LAD WAS TREATED WITH DIRECT PLACEMENT OF A 2.5 X 13 MM TAXUS STENT AND ANGIOPLASTY JUST DISTAL TO THE NEWLY PLACED STENT, WHICH RESULTED IN 0% RESIDUAL STENOSIS. THE PT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. IN THE OPINION OF THE PHYSICIAN, THERE IS NO RELATIONSHIP BETWEEN THE TAXUS STENT AND THE TVR. IN 2008, THE CLINICAL EVENTS COMMITTEE DETERMINED A POSSIBLE DEVICE RELATIONSHIP IN THE RCA TERRITORY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00486", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P040016", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS-A210", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20070201", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "LIBERTE' MONORAIL CORONARY STENT DELIVERY STENT", "generic_name": "MAF STENT, CORONARY", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20100221", "model_number": "NA", "catalog_number": "H749 38934 28300", "lot_number": "9433538", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "AL1 MEDTRONIC GUIDE CATHETER" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000408", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "781901", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), STENT DISLODGMENT OCCURRED. THE VERY CALCIFIED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREDILATED THE LESION MULTIPLE TIMES, AND SUCCESSFULLY DELIVERED A 3.00X20MM STENT (TYPE UNK) AND A 3.00X24MM STENT (TYPE UNK). THE PHYSICIAN THEN ATTEMPTED TO DELIVER THE 3.00X28MM LIBERTE BARE (MR) STENT. THE PHYSICIAN PULLED BACK ON THE STENT AND THE STENT CAUGHT ON THE CALCIFICATION IN THE LESION AND DISLODGED FROM THE BALLOON. THE PHYSICIAN WAS ABLE TO RETRIEVE THE STENT AND THE CASE WAS COMPLETED WITHOUT PT COMPLICATIONS. THE PT CONDITION IS REPORTED AS FINE. FURTHER INFO WAS REQUESTED, BUT WAS UNAVAILABLE." }, { "mdr_text_key": "7934166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE ANALYSIS. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00487", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "UNKNOWN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20070601", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20081110", "model_number": "3.00X32MM", "catalog_number": "H7493897032300", "lot_number": "9740817", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080124", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000409", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "793961", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED BY THE PATIENT THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, HAIR LOSS OCCURRED. THE PHYSICIAN IMPLANTED A 3.00X32MM TAXUS EXPRESS2 DRUG ELUTING STENT, AND A 3.00X16MM TAXUS EXPRESS2 DRUG ELUTING STENT IN AN UNSPECIFIED LOCATION. TWO TO THREE WEEKS LATER, THE PATIENT NOTICED HAIR LOSS. ADDITIONALLY, THE PT REPORTS DIFFICULTY BREATHING. THE PHYSICIAN DOES NOT KNOW IF THE HAIR LOSS IS RELATED TO THE TAXUS STENTS. FURTHER INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE." }, { "mdr_text_key": "8090648", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00488", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "1566", "reporter_occupation_code": "UNKNOWN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20070801", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20081227", "model_number": "3.00X16MM", "catalog_number": "H7493897016300", "lot_number": "11026393", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080124", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000410", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080124", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "BOSTON SCIENTIFIC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780205", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED BY THE PATIENT THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, HAIR LOSS OCCURRED. THE PHYSICIAN IMPLANTED A 3.00X32MM TAXUS EXPRESS2 DRUG ELUTING STENT AND A 3.00X16MM TAXUS EXPRESS2 DRUG ELUTING STENT IN AN UNSPECIFIED LOCATION. TWO TO THREE WEEKS LATER, THE PATIENT NOTICED HAIR LOSS. ADDITIONALLY, THE PT REPORTS DIFFICULTY BREATHING. THE PHYSICIAN DOES NOT KNOW IF THE HAIR LOSS IS RELATED TO THE TAXUS STENTS. FURTHER INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE." }, { "mdr_text_key": "7934167", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "1566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76350505", "event_type": "Injury", "report_number": "2134265-2008-00491", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PATIENT", "manufacturer_contact_plocal": "7635050529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Consumer", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20060601", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "2.5X24MM", "catalog_number": "H7493897024250", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7635", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080125", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000411", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080212", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "793962", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS MFR REPORT #2134265-2008-00490. IT WAS REPORTED BY THE PATIENT, THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, VESSEL OCCLUSION OCCURRED. THE PT REPORTED, THAT \"HE HAD AN ELEVATED BLOOD PRESSURE ON FOLLOW UP AND WAS HOSPITALIZED\". HE REPORTED, THAT \"HE HAS OTHER TAXUS EXPRESS2 DRUG ELUTING STENTS (DES) BUT THIS PARTICULAR LEFT ANTERIOR DESCENDING ARTERY (LAD) STENT WAS FOUND TO BE 100% BLOCKED DURING THE PROCEDURE.\" ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S PHYSICIAN, REPORTS THAT THE 70% STENOSED TARGET LESION WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.0X20MM MAVERICK BALLOON. A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE TARGET LESION AT 11 ATMOSPHERES (ATMS) FOR 30 SECONDS (SECS). THERE WAS NO RESIDUAL STENOSIS NOTED AND NO PATIENT COMPLICATIONS REPORTED. AT 200 DAYS LATER, A 2.5X12MM TAXUS EXPRESS2 DES WAS DEPLOYED IN THE MID LAD AT 17 ATMS FOR 10 SECS TO TREAT AN UNSPECIFIED LESION. THERE WAS NO RESIDUAL STENOSIS NOTED AND NO PATIENT COMPLICATIONS REPORTED. AT 347 DAYS LATER, IN A CONSULTATION WITH HIS PHYSICIAN, THE PT COMPLAINED OF HAVING EPISODES OF CHEST PAIN WITH ELEVATED BLOOD PRESSURE, INCREASED DYSPNEA AS WELL AS EXERTIONAL ANGINA. TWO DAYS LATER, UNSUCCESSFUL ATTEMPTS WERE MADE TO CROSS THE \"CHRONIC, OLD TOTAL MID-LAD OCCLUSION\" WITH A 180CM LUGE GUIDEWIRE AND A CHOICE PT GUIDEWIRE. THE DECISION WAS MADE TO END THE PROCEDURE WITH NO PT COMPLICATIONS REPORTED. THE PT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION ON THE FOLLOWING MEDICATIONS: RANEXA 500MG DAILY, LISINOPRIL 2.5MG DAILY, TRAZODONE 200MG AT BEDTIME, LIPITOR 80MG AT BEDTIME, ASPIRIN 325MG DAILY, DOCUSATE SODIUM 100MG TWICE A DAY, OMEPRAZOLE 20MG DAILY, PLAVIX 75MG DAILY, SERTRALIN 100MG 2 TABLETS DAILY, SOTALOL 120MG TWICE A DAY, VITAMIN 5 DAILY, WELLBUTRIN 200MG TWICE A DAY, HYDROCODONE 5/500 AS NEEDED EVERY 6 HOURS AS NEEDED FOR PAIN. THE PT IS ON MEDICAL MANAGEMENT AS TREATMENT OF HIS KNOWN CORONARY ARTERY DISEASE." }, { "mdr_text_key": "8090649", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00490", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PATIENT", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE,MS A210", "source_type": [ "Consumer", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "device_date_of_manufacturer": "20060601", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20070521", "model_number": "2.5X12MM", "catalog_number": "H7493897012250", "lot_number": "8818445", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080125", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000412", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080125", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780206", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE AS MFR REPORT #2134265-2008-00491. IT WAS REPORTED BY THE PATIENT THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, VESSEL OCCLUSION OCCURRED. THE PT REPORTED THAT \"HE HAD AN ELEVATED BLOOD PRESSURE ON FOLLOW UP AND WAS HOSPITALIZED\". HE REPORTED THAT \"HE HAS OTHER TAXUS EXPRESS2 DRUG ELUTING STENTS (DES), BUT THIS PARTICULAR LEFT ANTERIOR DESCENDING ARTERY (LAD) STENT WAS FOUND TO BE 100% BLOCKED DURING THE PROCEDURE.\" ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S PHYSICIAN REPORTS THAT THE 70% STENOSED TARGET LESION WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.0X20MM MAVERICK BALLOON. A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE TARGET LESION AT 11 ATMOSPHERES (ATMS) FOR 30 SECONDS (SECS). THERE WAS NO RESIDUAL STENOSIS NOTED AND NO PATIENT COMPLICATIONS REPORTED. AT 200 DAYS LATER, A 2.5X12MM TAXUS EXPRESS2 DES WAS DEPLOYED IN THE MID LAD AT 17 ATMS FOR 10 SECS TO TREAT AN UNSPECIFIED LESION. THERE WAS NO RESIDUAL STENOSIS NOTED AND NO PATIENT COMPLICATIONS REPORTED. AT 347 DAYS LATER, IN A CONSULTATION WITH HIS PHYSICIAN, THE PT COMPLAINED OF HAVING EPISODES OF CHEST PAIN WITH ELEVATED BLOOD PRESSURE, INCREASED DYSPNEA AS WELL AS EXERTIONAL ANGINA. TWO DAYS LATER, UNSUCCESSFUL ATTEMPTS WERE MADE TO CROSS THE \"CHRONIC, OLD TOTAL MID-LAD OCCLUSION\" WITH A 180CM LUGE GUIDEWIRE AND A CHOICE PT GUIDEWIRE. THE DECISION WAS MADE TO END THE PROCEDURE WITH NO PT COMPLICATIONS REPORTED. THE PT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION ON THE FOLLOWING MEDICATIONS: RANEXA 500MG DAILY, LISINOPRIL 2.5MG DAILY, TRAZODONE 200MG AT BEDTIME, LIPITOR 80MG AT BEDTIME, ASPIRIN 325MG DAILY, DOCUSATE SODIUM 100MG TWICE A DAY, OMEPRAZOLE 20MG DAILY, PLAVIX 75MG DAILY, SERTRALIN 100MG 2 TABLETS DAILY, SOTALOL 120MG TWICE A DAY, VITAMIN 5 DAILY, WELLBUTRIN 200MG TWICE A DAY, HYDROCODONE 5/500 AS NEEDED EVERY 6 HOURS AS NEEDED FOR PAIN. THE PT IS ON MEDICAL MANAGEMENT AS TREATMENT OF HIS KNOWN CORONARY ARTERY DISEASE." }, { "mdr_text_key": "7934168", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "BALLYBRIT BUSINESS PARK", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00475", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20050120", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Unknown" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "2.5X20MM", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080128", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000413", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080128", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "15614324", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE MFR REPORT #2134265-2008-00476 AND #2134265-2008-00477. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THROMBOSIS OCCURRED. THE PROCEDURE WAS EMERGENT DUE TO CHEST PAIN AND MYOCARDIAL INFARCTION (MI). A 2.5X20MM NON-BSC BALLOON CATHETER WAS USED TO PREDILATE THE PROXIMAL RIGHT CORONARY ARTERY (RCA), MID RCA AND POSTEROLATERAL BRANCH (PLB) OF THE RCA. A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE PLB, A 3.0X28MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE MID RCA AND A 3.5X28MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE PROXIMAL RCA. ALL DEVICES SHOWED \"GOOD ANGIOGRAPHIC RESULTS\" WITH 0% STENOSIS. THE 40% LESION JUST BEFORE THE CRUX WAS DILATED TO 14 ATMOSPHERES (ATMS) WITH AN UNSPECIFIED BALLOON. SEVEN DAYS LATER, THE PATIENT HAD RECURRENT CHEST PAIN. A 2.75X20MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE DISTAL RCA AND A 2.5X12MM TAXUS EXPRESS2 DES WAS IMPLANTED IN PLB TO THE RCA. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS DISCHARGED ON LIPITOR 20MG DAILY, MAVIK 2MG DAILY, TOPROL XL 50MG DAILY, PLAVIX 75MG DAILY, ENTERIC COATED ASPIRIN 325MG DAILY AND ISORDIL 30MG DAILY. AT 259 DAYS LATER, THE PATIENT SUFFERED AN ACUTE INFERIOR-POSTERIOR MI AND THROMBOSIS WAS DISCOVERED IN THE PLB. A 2.5X15MM NON-BSC BALLOON CATHETER WAS USED TO TREAT THE THROMBOSIS. TIMI 3 FLOW WAS RESTORED. THE PT BECAME IMMEDIATELY BRADYCARDIC AND HYPERTENSIVE AND AN UNK TYPE TEMPORARY PACING WIRE WAS PLACED VIA THE FEMORAL VEIN APPROACH INTO THE RIGHT VENTRICLE. THE BRADYCARDIA RESOLVED. A 2.75X9MM NC MONORAIL BALLOON CATHETER WAS ALSO USED TO DILATE THE AREA OF THROMBOSIS. THERE WAS NO RESIDUAL STENOSIS PRESENT WITH TIMI 3 FLOW RESTORED. THE PATIENT'S CHEST PAIN AND EKG CHANGES RESOLVED. THE PATIENT RECEIVED HEPARIN, REOPRO, NITROGLYCERIN, DURING THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS UNK." }, { "mdr_text_key": "15887484", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00477", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20050120", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Unknown" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "2.5X12MM", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080128", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000414", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080128", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "794072", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE MFR REPORT #2134265-2008-00475 AND #2134265-2008-00476. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THROMBOSIS OCCURRED. THE PROCEDURE WAS EMERGENT DUE TO CHEST PAIN AND MYOCARDIAL INFARCTION (MI). A 2.5X20MM NON-BSC BALLOON CATHETER WAS USED TO PREDILATE THE PROXIMAL RIGHT CORONARY ARTERY (RCA), MID RCA AND POSTEROLATERAL BRANCH (PLB) OF THE RCA. A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE PLB, A 3.0X28MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE RCA AND A 3.5X28MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE PROXIMAL RCA. ALL DEVICES SHOWED \"GOOD ANGIOGRAPHIC RESULTS\" WITH 0% STENOSIS. THE 40% LESION JUST BEFORE THE CRUX WAS DILATED TO 14 ATMOSPHERES (ATMS) WITH AN UNSPECIFIED BALLOON. SEVEN DAYS LATER, THE PATIENT HAD RECURRENT CHEST PAIN. A 2.75X20MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE DISTAL RCA AND A 2.5X12MM TAXUS EXPRESS2 DES WAS IMPLANTED IN PLB TO THE RCA. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS DISCHARGED ON LIPITOR 20MG DAILY, MAVIK 2MG DAILY, TOPROL XL 50MG DAILY, PLAVIX 75MG DAILY, ENTERIC COATED ASPIRIN 325MG DAILY AND ISORDIL 30MG DAILY. AT 259 DAYS LATER, THE PATIENT SUFFERED AN ACUTE INFERIOR-POSTERIOR MI AND THROMBOSIS WAS DISCOVERED IN THE PLB. A 2.5X15MM NON-BSC BALLOON CATHETER WAS USED TO TREAT THE THROMBOSIS. TIMI 3 FLOW WAS RESTORED. THE PT BECAME IMMEDIATELY BRADYCARDIC AND HYPERTENSIVE AND AN UNK TYPE TEMPORARY PACING WIRE WAS PLACED VIA THE FEMORAL VEIN APPROACH INTO THE RIGHT VENTRICLE. THE BRADYCARDIA RESOLVED. A 2.75X9MM NC MONORAIL BALLOON CATHETER WAS ALSO USED TO DILATE THE AREA OF THROMBOSIS. THERE WAS NO RESIDUAL STENOSIS PRESENT WITH TIMI 3 FLOW RESTORED. THE PT'S CHEST PAIN AND EKG CHANGES RESOLVED. THE PATIENT RECEIVED HEPARIN, REOPRO, NITROGLYCERIN, DURING THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS UNK." }, { "mdr_text_key": "8090650", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Injury", "report_number": "2134265-2008-00476", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20050120", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Unknown" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080226", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "2.75X20MM", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080226", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080128", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000415", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080128", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780207", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SAME CASE MFR REPORT #2134265-2008-00475 AND #2134265-2008-00477. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE PROCEDURE WAS EMERGENT DUE TO CHEST PAIN AND MYOCARDIAL INFARCTION (MI). A 2.5X20MM NON-BSC BALLOON CATHETER WAS USED TO PREDILATE THE PROXIMAL RIGHT CORONARY ARTERY (RCA), MID RCA AND POSTEROLATERAL BRANCH (PLB) OF THE RCA. A 2.5X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE PLB, A 3.0X28MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE MID RCA AND A 3.5X28MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE PROXIMAL RCA. ALL DEVICES SHOWED \"GOOD ANGIOGRAPHIC RESULTS\" WITH 0% STENOSIS. THE 40% LESION JUST BEFORE THE CRUX WAS DILATED TO 14 ATMOSPHERES (ATMS) WITH AN UNSPECIFIED BALLOON. SEVEN DAYS LATER, THE PATIENT HAD RECURRENT CHEST PAIN. A 2.75X20MM TAXUS EXPRESS2 DES WAS IMPLANTED IN THE DISTAL RCA AND A 2.5X12MM TAXUS EXPRESS2 DES WAS IMPLANTED IN PLB TO THE RCA. THERE WAS NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS DISCHARGED ON LIPITOR 20MG DAILY, MAVIK 2MG DAILY, TOPROL XL 50MG DAILY, PLAVIX 75MG DAILY, ENTERIC COATED ASPIRIN 325 MG DAILY AND ISORDIL 30MG DAILY. AT 259 DAYS LATER, THE PATIENT SUFFERED AN ACUTE INFERIOR-POSTERIOR MI AND THROMBOSIS WAS DISCOVERED IN THE PLB. A 2.5X15MM NON-BSC BALLOON CATHETER WAS USED TO TREAT THE THROMBOSIS. TIMI 3 FLOW WAS RESTORED. THE PT BECAME IMMEDIATELY BRADYCARDIC AND HYPERTENSIVE, AND AN UNK TYPE TEMPORARY PACING WIRE WAS PLACED VIA THE FEMORAL VEIN APPROACH INTO THE RIGHT VENTRICLE. THE BRADYCARDIA RESOLVED. A 2.75X9MM NC MONORAIL BALLOON CATHETER WAS ALSO USED TO DILATE THE AREA OF THROMBOSIS. THERE WAS NO RESIDUAL STENOSIS PRESENT WITH TIMI 3 FLOW RESTORED. THE PATIENT'S CHEST PAIN AND EKG CHANGES RESOLVED. THE PATIENT RECEIVED HEPARIN, REOPRO, NITROGLYCERIN, DURING THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS UNK." }, { "mdr_text_key": "7934169", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "PARQUE INDUSTRIAL SALVARCAR", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "DR", "manufacturer_contact_state": "FL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "JUAREZ, CHIHUAHUA", "manufacturer_contact_address_1": "14201 N.W. 60TH AVE", "manufacturer_contact_pcity": "78631362", "event_type": "No answer provided", "report_number": "9616099-2008-00369", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080215", "manufacturer_address_2": "", "pma_pmn_number": "NA", "date_of_event": "20071218", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "33014", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "7863136240", "noe_summarized": "1", "manufacturer_contact_l_name": "PATEL, MEDICAL DIRECTOR", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "786", "date_added": "20080228", "manufacturer_contact_f_name": "GAURANG", "device_date_of_manufacturer": "20070701", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080215", "brand_name": "CYPHER SIROLIMUS-ELUTING CORONARY STENT", "generic_name": "DRUG-ELUTING STENT (NIQ)", "manufacturer_d_name": "CORDIS DE MEXICO", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "JUAREZ, CHIHUAHUA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "MX", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20071019", "model_number": "NA", "catalog_number": "CJS18250", "lot_number": "13250474", "other_id_number": "PART#: NA", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080228", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7863", "patient": [ { "patient_sequence_number": "1", "date_received": "20080215", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "73 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080122", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "MX", "manufacturer_contact_city": "MIAMI LAKES", "mdr_report_key": "1000419", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080122", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CORDIS DE MEXICO", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "794074", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING REPORT WAS RECEIVED FROM THE AFFILIATE: ON 12/2007 AN X-RAY WAS PERFORMED FOR PROGNOSIS OF PANCREATODUODENECTOMY. AFTER THAT, THE PATIENT COMPLAINED OF CHEST DISCOMFORT AND ABNORMAL ELECTROCARDIOGRAM (ECG) WAS OBSERVED. CORONARY ANGIOGRAM (CAG) WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE 2ND CYPHER AT THE CIRCUMFLEX. THROMBUS WAS NOT OBSERVED IN THE 1ST CYPHER AT THE LAD. TO TREAT THE THROMBUS, PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS CONDUCTED. TEN DAYS LATER, THE PATIENT RECOVERED AND MOVED TO ANOTHER DIVISION FOR PANCREATODUODENECTOMY. PHYSICIAN'S COMMENT: THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE ANTI-PLATELET MEDICINE WAS STOPPED. ASPIRIN AND CLOPIDOGREL SULFATE WERE STOPPED DUE TO PANCREATODUODENECTOMY." }, { "mdr_text_key": "8090180", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD) AND DISTAL CIRCUMFLEX. THE LESION WAS A DE-NOVO, ECCENTRIC AND CALCIFIED LESION. LESION CLASSIFICATION WAS TYPE B2. THE LESION LENGTH WAS 20MM AND VESSEL DIAMETER WAS 2.25MM. THE LESION AT THE CIRCUMFLEX WAS A DE-NOVO AND CONCENTRIC LESION. LESION CLASSIFICATION WAS TYPE B2. THE LESION LENGTH WAS 15MM AND VESSEL DIAMETER WAS 2.25MM. AT THE LAD, PRE-DILATATION WAS CONDUCTED WITH A 2.0X15MM BALLOON AT 22ATM FOR 3SECONDS. THE FIRST 2.5X28MM CYPHER STENT WAS DEPLOYED AT 20ATM FOR 3SECONDS. POST DILATATION WAS CONDUCTED WITH A 2.75 X 13 MM BALLOON AT 22 ATM FOR 3SECONDS. INTRAVASCULAR ULTRASOUND (IVUS) WAS CONDUCTED. THE RESIDUAL PERCENT OF STENOSIS WAS 0%. TIMI FLOW PRE AND POST PROCEDURE WAS III. AT THE CIRCUMFLEX, PRE-DILATATION WAS CONDUCTED; UNK DEVICE. THE SECOND 2.5X18MM CYPHER STENT WAS DEPLOYED AT 20ATM FOR 3SECONDS. POST-DILATATION WAS CONDUCTED WITH A 2.75X13MM BALLOON AT 20ATM FOR 3SECONDS. IVUS WAS NOT CONDUCTED. THE RESIDUAL PERCENT OF STENOSIS WAS 0%. TIMI FLOW PRE AND POST PROCEDURE WAS III. ACTIVATED CLOTTING TIME (ACT) WAS MEASURED. IN 2007 A PANCREATODUODENECTOMY WAS CONDUCTED. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "CIRCUITO INTERIOR NORTE #1820", "distributor_zip_code": "", "manufacturer_contact_postal_code": "33014", "manufacturer_contact_exchange": "786", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "1566", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "ONE SCIMED PLACE", "manufacturer_contact_pcity": "76325505", "event_type": "Death", "report_number": "2134265-2008-00489", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080220", "manufacturer_address_2": "", "pma_pmn_number": "P030025", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55311", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7632550529", "noe_summarized": "1", "manufacturer_contact_l_name": "GAYLE, MS A210", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20080225", "manufacturer_contact_f_name": "MARK", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080220", "brand_name": "TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM", "generic_name": "NIQ STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "BOSTON SCIENTIFIC", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "3.0X32MM", "catalog_number": "H7493896832300", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "Y", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080225", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7632", "patient": [ { "patient_sequence_number": "1", "date_received": "20080220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "57 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "MAPLE GROVE", "mdr_report_key": "1000420", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780302", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS AND DEATH OCCURRED. THE PT PRESENTED INITIALLY WITH ST ELEVATION MYOCARDIAL INFARCTION (MI) AND 90% OCCLUSION IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 2.0X15MM AND 2.5X20MM MAVERICK BALLOON. THE PHYSICIAN THEN IMPLANTED A TAXUS EXPRESS2 3.0X32MM DRUG ELUTING STENT AND POST DILATED WITH A 3.5MM QUANTUM MAVERICK BALLOON. NO PT COMPLICATIONS WERE REPORTED. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. LATER THAT DAY, THE PT SHOWED ST ELEVATION MI AGAIN. ANGIOGRAPHY REVEALED THAT THE PREVIOUSLY PLACED TAXUS STENT WAS COMPLETELY OCCLUDED WITH THROMBUS. MULTIPLE PASSES WERE PERFORMED WITH AN ASPIRATION CATHETER TO REMOVE THE CLOT. THE PHYSICIAN NOTED THAT AS THEY WERE CLEARING THE CLOT MORE CLOT WAS FORMING. ANGIOMAX WAS ADMINISTERED AND SEVERAL DILATATIONS WERE PERFORMED WITH A 2.0X12MM UP TO A 2.5X20 MAVERICK BALLOON AND FINISHING WITH A 3.0X15MM QUANTUM MAVERICK BALLOON. POST PROCEDURE, THE PT STATUS WAS CRITICAL, BUT STABLE. THE PT DIED LATER THAT DAY. THE CAUSE OF DEATH IS NOTED AS RETROPERITONEAL BLEED. THE RELATIONSHIP OF THE DEATH TO THIS DEVICE IS UNK. ADDITIONAL INFO REGARDING THIS EVENT HAS BEEN REQUESTED." }, { "mdr_text_key": "7934171", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "553111566", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_contact_pcity": "09170873", "event_type": "Death", "report_number": "9612164-2020-01697", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P160043", "date_of_event": "20200225", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "091708734", "noe_summarized": "1", "manufacturer_contact_l_name": "O'DOHERTY", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "091", "date_added": "20200428", "manufacturer_contact_f_name": "TONI", "device_date_of_manufacturer": "20190918", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "RESOLUTE ONYX RX", "generic_name": "STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20210917", "model_number": "RONYX20008UX", "catalog_number": "RONYX20008UX", "lot_number": "0009926452", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00643169556621", "udi_public": "00643169556621", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/28/2020", "manufacturer_contact_country": "", "date_changed": "20200601", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "0917", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Death" ] } ], "distributor_city": "", "date_report": "20200529", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "GALWAY", "mdr_report_key": "10004210", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200408", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC IRELAND", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189139223", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189139224", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING A PROCEDURE, ONE RESOLUTE ONYX RX (2.00X12) WAS ATTEMPTED TO BE USED AND ONE RESOLUTE ONYX RX (2.00X08) WAS IMPLANTED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE RESOLUTE ONYX (2.00X12) STENT FAILED TO CROSS THE LESION. THE LESION WAS TREATED BY PRE-DILATION USING A NON MEDTRONIC BALLOON AND A RESOLUTE ONYX (2.00X08) WAS IMPLANTED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT SUFFERED A CARDIAC ARREST AND DECEASED FOLLOWING THE PROCEDURE." }, { "mdr_text_key": "194232427", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "PARKMORE BUSINESS PARK WEST", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "091", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "05/29/2020" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_contact_pcity": "09170873", "event_type": "Death", "report_number": "9612164-2020-01698", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "P110013", "date_of_event": "20191105", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "091708734", "noe_summarized": "1", "manufacturer_contact_l_name": "O'DOHERTY", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "NL", "manufacturer_contact_area_code": "091", "date_added": "20200428", "manufacturer_contact_f_name": "TONI", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20200428", "brand_name": "RESOLUTE INTEGRITY RX", "generic_name": "STENT, CORONARY, DRUG-ELUTING", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "IE", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NIQ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Coronary Drug-Eluting Stent", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "9612164" ], "fei_number": [ "3002806434" ] } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem" ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "IE", "date_changed": "20200603", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "0917", "patient": [ { "patient_sequence_number": "1", "date_received": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "63 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20200428", "initial_report_to_fda": "No answer provided", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IE", "manufacturer_contact_city": "GALWAY", "mdr_report_key": "10004224", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200424", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC IRELAND", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189148254", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "PATIENT AGE: AVERAGE AGE. PATIENT SEX: MAJORITY GENDER. DATE OF EVENT: DATE OF PUBLICATION. JOURNAL ARTICLE TITLE: PROXIMAL LAD TREATED WITH THIN-STRUT NEW-GENERATION DRUG-ELUTING STENTS LITERATURE. REFERENCE: DOI.ORG/10.1016/J.JCIN.2019.11.018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189148255", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE AIM OF THIS POST HOC ANALYSIS OF PATIENT-LEVEL DATA FROM 3 RANDOMIZED CLINICAL TRIALS IS TO ASSESS 2-YEAR CLINICAL OUTCOME FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH THIN-STRUT NEW-GENERATION DRUG-ELUTING STENTS (DES) IN PATIENTS TREATED IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (P-LAD) VERSUS NON\u00bfP-LAD LESIONS. THE STUDY INCLUDED 6,037 PATIENTS WITHOUT PREVIOUS BYPASS SURGERY OR LEFT MAIN STEM INVOLVEMENT FROM THE (B)(6) RANDOMIZED TRIALS. A TOTAL OF 1,607 PATIENTS HAD AT LEAST 1 DES IMPLANTED IN P-LAD AND WERE COMPARED WITH 4,430 PATIENTS WHO WERE EXCLUSIVELY TREATED IN OTHER (NON\u00bfP-LAD) SEGMENTS. TWO-YEAR FOLLOW-UP WAS AVAILABLE IN 5,995 PATIENTS. DATA FROM ALL TRIAL PARTICIPANTS, EXCEPT FOR THOSE WHO WERE STENTED FOR LEFT MAIN DISEASE OR PREVIOUSLY HAD CABG, WERE ANALYSED. ENDEAVOR RESOLUTE AND RESOLUTE INTEGRITY WERE AMONG A NUMBER OF STENTS IMPLANTED IN THE STUDY POPULATION. IT WAS STATED THAT GENERALLY, DUAL-ANTIPLATELET THERAPY WAS PRESCRIBED FOR 6 TO 12 MONTHS. THE STUDY ASSESSED 2 MAIN COMPOSITE CLINICAL ENDPOINTS: THE PATIENT-ORIENTED COMPOSITE ENDPOINT (POCE) (ANY DEATH, ANY MYOCARDIAL INFARCTION [MI], OR ANY REPEAT REVASCULARIZATION) AND THE DEVICE-ORIENTED COMPOSITE ENDPOINT TARGET LESION FAILURE (TLF) (CARDIAC DEATH, TARGET VESSEL MI, OR TARGET LESION REVASCULARIZATION). CLINICAL OUTCOMES INCLUDED ALL-CAUSE DEATHS, CARDIAC DEATHS, TARGET VESSEL MYOCARDIAL INFARCTION, ANY REPEAT REVASCULARIZATION INCLUDING TARGET LESION REVASCULARIZATION AND DEFINITE OR PROBABLE STENT THROMBOSIS. TWO CASES OF CARDIAC DEATH IN RESOLUTE-TYPE STENTS WERE RELATED TO DEFINITE STENT THROMBOSIS CASES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "PARKMORE BUSINESS PARK WEST", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "091", "manufacturer_contact_pcountry": "353", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA ROSA", "manufacturer_contact_address_1": "3576 UNOCAL PL.", "manufacturer_contact_pcity": "70759178", "event_type": "Injury", "report_number": "2953200-2008-00071", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080221", "manufacturer_address_2": "", "pma_pmn_number": "P990020", "date_of_event": "20080130", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95403", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7075917844", "noe_summarized": "1", "manufacturer_contact_l_name": "BERGER", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95403", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "707", "date_added": "20080303", "manufacturer_contact_f_name": "STEPHANIE", "device_date_of_manufacturer": "20080109", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080221", "brand_name": "ANEURX AAADVANATAGE STENT GRAFT SYSTEM-HYDRO", "generic_name": "", "manufacturer_d_name": "MEDTRONIC CARDIOVASCULAR", "manufacturer_d_address_1": "3576 UNOCAL PL.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA ROSA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95403", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95403", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20100108", "model_number": "NA", "catalog_number": "BFXCH2816165", "lot_number": "V00073042", "other_id_number": "NA", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080303", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7075", "patient": [ { "patient_sequence_number": "1", "date_received": "20080221", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "83 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080130", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA ROSA", "mdr_report_key": "1000423", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080130", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "95403", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC CARDIOVASCULAR", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780303", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING THE PERCUTANEOUS APPROACH. THE AORTIC NECK WAS 2CM LONG AND IT WAS 25MM IN DIAMETER WITH ANGULATION OF 35-40 DEGREES AND MILD THROMBUS. THE PT WAS AWAKE AND WAS MOVING AROUND DURING THE PROCEDURE. IT WAS REPORTED THE BIFURCATED STENT GRAFT WAS POSITIONED AND DEPLOYED RIGHT BELOW THE RENAL ARTERIES; HOWEVER, DURING THE PROCEDURE, THE DELIVERY SYSTEM ACCIDENTALLY PARTIALLY FELL OFF OVER THE SIDE OF THE TABLE. THIS SITUATION WAS REMEDIED ANY THEY CONTINUED WITH IMPLANTATION OF THE REMAINING STENT GRAFT. AT THE END OF THE PROCEDURE WHEN PICTURES WERE TAKEN, THE BIFURCATED STENT GRAFT WAS FOUND 1CM BELOW THE RENAL ARTERIES. THIS REQUIRED A 28MM ANEURX AORTIC CUFF TO BE IMPLANTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE." }, { "mdr_text_key": "7934172", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVALUATION - RESULT: INCORRECT TECHNIQUE/PROCEDURE (DELIVERY SYSTEM NOT STABLE DURING THE PROCEDURE). EVALUATION - CONCLUSION: DEVICE FAILURE RELATED TO USER HANDLING (DELIVERY SYSTEM NOT STABLE DURING THE PROCEDURE). REQUIRED SECONDARY INTERVENTION)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3576 UNOCAL PL.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95403", "manufacturer_contact_exchange": "707", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA ROSA", "manufacturer_contact_address_1": "3576 UNOCAL PL.", "manufacturer_contact_pcity": "77591784", "event_type": "Injury", "report_number": "2953200-2008-00070", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080221", "manufacturer_address_2": "", "pma_pmn_number": "P990020", "date_of_event": "20080125", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95403", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "775917844", "noe_summarized": "1", "manufacturer_contact_l_name": "BERGER", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95403", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "775", "date_added": "20080303", "manufacturer_contact_f_name": "STEPHANIE", "device_date_of_manufacturer": "20030910", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080221", "brand_name": "ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT", "generic_name": "", "manufacturer_d_name": "MEDTRONIC CARDIOVASCULAR", "manufacturer_d_address_1": "3576 UNOCAL PL.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA ROSA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95403", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95403", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20050912", "model_number": "NA", "catalog_number": "YRBRX2816165", "lot_number": "M03H551286", "other_id_number": "NA", "device_availability": "No", "device_report_product_code": "MIH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20080303", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7759", "patient": [ { "patient_sequence_number": "1", "date_received": "20080221", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "82 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080128", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA ROSA", "mdr_report_key": "1000424", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080128", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "95403", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC CARDIOVASCULAR", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "794199", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PT PRESENTED WITH ABDOMINAL PAIN. AN ANGIOGRAM WAS PERFORMED AND REVEALED A PROXIMAL TYPE 1 ENDOLEAK AND THAT THE BIFURCATED DEVICE MAY HAVE MIGRATED 3CM. THE PT WAS FROM A DIFFERENT STATE, AND IT IS UNK WHETHER THERE WERE REGULAR FOLLOW-UP VISITS OVER THE PAST 3.5 YRS SINCE IMPLANT. IT WAS ALSO REPORTED THE AORTIC NECK WAS 24-25MM IN DIAMETER AND THAT THE TYPE 1 ENDOLEAK MIGHT HAVE BEEN PRESENT AT THE ORIGINAL IMPLANT. ANOTHER MANUFACTURER'S AORTIC CUFF WAS IMPLANTED PROXIMALLY AND RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED." }, { "mdr_text_key": "8090182", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVALUATION - RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION). PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ENDOLEAK MAY HAVE BEEN PRESENT AT IMPLANT). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (ENDOLEAK MAY HAVE BEEN PRESENT AT IMPLANT). REQUIRED SECONDARY INTERVENTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3576 UNOCAL PL.", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95403", "manufacturer_contact_exchange": "775", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" }, { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "GALWAY", "manufacturer_contact_address_1": "3576 UNOCAL PL.", "manufacturer_contact_pcity": "70759178", "event_type": "Injury", "report_number": "2953200-2008-00069", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20080221", "manufacturer_address_2": "", "pma_pmn_number": "P030009", "date_of_event": "20080123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95403", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7075917844", "noe_summarized": "1", "manufacturer_contact_l_name": "BERGER", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "707", "date_added": "20080303", "manufacturer_contact_f_name": "STEPHANIE", "device_date_of_manufacturer": "20071022", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080221", "brand_name": "MICRO DRIVER RX CORONARY STENT SYSTEM", "generic_name": "", "manufacturer_d_name": "MEDTRONIC IRELAND", "manufacturer_d_address_1": "PARKMORE BUSINESS PARK WEST", "manufacturer_d_address_2": "", "manufacturer_d_city": "GALWAY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "EI", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20091022", "model_number": "NA", "catalog_number": "DRV25018X", "lot_number": "0000600283", "other_id_number": "NA", "device_availability": "No", "device_report_product_code": "MAF", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Stent, Coronary", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "2953200" ], "fei_number": [ "3001452571" ] } } ], "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "manufacturer_contact_country": "US", "date_changed": "20171212", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7075", "patient": [ { "patient_sequence_number": "1", "date_received": "20080221", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "UNK YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "" } ], "distributor_city": "", "date_report": "20080123", "initial_report_to_fda": "Unknown", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "EI", "manufacturer_contact_city": "SANTA ROSA", "mdr_report_key": "1000425", "removal_correction_number": "NA", "number_devices_in_event": "", "date_manufacturer_received": "20080123", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDTRONIC IRELAND", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "780419", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A 2.5MM DIAMETER X 18MM LENGTH MICRO DRIVER RX CORONARY STENT SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A DISTAL LAD LESION. THE VESSEL MORPHOLOGY WAS REPORTED AS MODERATE TORTUOUSITY WITH SEVERE CALCIFICATION AND 100% STENOSIS. THE LESION WAS PRE-DILATED WITH TWO BALLOONS. IT WAS REPORTED THAT THE PHYSICIAN HAD IMPLANTED ANOTHER MANUFACTURER'S DRUG ELUTING STENT FIRST IN THE PROXIMAL LAD: A SECOND DRUG ELUTING STENT FROM THE SAME MANUFACTURER WAS UNABLE TO CROSS THE LESION AFTER THAT. THE MICRO DRIVER WAS INSPECTED BY THE PHYSICIAN PRIOR TO USE AND NO ISSUES WERE NOTED. IT WAS REPORTED THAT THE PHYSICIAN THEN ATTEMPTED THE MICRO DRIVER, HOWEVER, IT WAS UNABLE TO CROSS AND WAS REMOVED. A NEW GUIDE CATHETER WAS INSERTED AND THE MICRO DRIVER WAS RE-INSERTED TO THE LESION SITE. THE STENT DELIVERY BALLOON WAS INFLATED AND AT THAT TIME THE PHYSICIAN NOTICED THE STENT WAS NOT ON THE STENT DELIVERY SYSTEM. THE PHYSICIAN PERFORMED A CONTRAST STUDY AND COULD NOT FIND THE DISLODGED STENT. THE PHYSICIAN STATED THAT THE DISLODGED STENT MIGHT BE SUBMERGED IN THE SEVERE CALCIFICATION NEAR THE LESION SITE. THE LESION SITE WAS TREATED WITH POBA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT'S STATUS IS STABLE. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT." }, { "mdr_text_key": "7934173", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (RESISTANCE ENCOUNTERED AND FORCE EXERTED ON DEVICE). PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (MODERATE TORTUOSITY WITH SEVERE CALCIFICATION AND 100% STENOSIS). INHERENT RISK OF PROCEDURE (STENT DISLODGEMENT). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (MODERATE TORTUOSITY WITH SEVERE CALCIFICATION AND 100% STENOSIS). USER ERROR CONTRIBUTED TO EVENT (RESISTANCE ENCOUNTERED AND FORCE EXERTED ON DEVICE). (SECONDARY INTERVENTION)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "PARKMORE BUSINESS PARK WEST", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95403", "manufacturer_contact_exchange": "707", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ]