SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Report

Report Number: 2124215-2025-66153
Event Type: Injury
Date Received: September 22, 2025
Date of Event: November 1, 2022
Report Date: November 5, 2025
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: NGV
Removal / Correction Number: 97423085-FA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H7: CORRECTED FROM NO REMEDIAL ACTION APPLIES TO OTHER, PRODUCT ADVISORY H9: ADDED 97423085-FA. LITERATURE CITATION: ZAHID, S. ET AL (NOVEMBER 2022). TRENDS AND OUTCOMES OF LEFT ATRIAL APPENDAGE OCCLUSION IN RENAL AND LIVER TRANSPLANT. CURRENT PROBLEMS IN CARDIOLOGY 48(2):101488. DOI: 10.1016/J.CPCARDIOL.2022.101488. B3: APPROXIMATED EVENT DATE USING LITERATURE ARTICLE PUBLISH DATE, AS EVENT DATES ARE UNKNOWN. D1: BRAND NAME IS BLANK BECAUSE THE DEVICE IS KNOWN TO BE A WATCHMAN DEVICE, BUT THE EXACT BRAND NAME IS UNKNOWN. D4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 0

LITERATURE CITATION: ZAHID, S. ET AL (NOVEMBER 2022). TRENDS AND OUTCOMES OF LEFT ATRIAL APPENDAGE OCCLUSION IN RENAL AND LIVER TRANSPLANT. CURRENT PROBLEMS IN CARDIOLOGY 48(2):101488. DOI: 10.1016/J.CPCARDIOL.2022.101488. B3: APPROXIMATED EVENT DATE USING LITERATURE ARTICLE PUBLISH DATE, AS EVENT DATES ARE UNKNOWN. D1: BRAND NAME IS BLANK BECAUSE THE DEVICE IS KNOWN TO BE A WATCHMAN DEVICE, BUT THE EXACT BRAND NAME IS UNKNOWN. D4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 0

REPORTED VIA JOURNAL ARTICLE: IT WAS REPORTED THAT SERIOUS INJURIES OCCURRED. THE FOLLOWING EVENT WAS OBTAINED VIA A RETROSPECTIVE ARTICLE FOLLOWING 61,995 PATIENTS FROM THE NATIONAL INPATIENT SAMPLE (NIS) AND 55,048 PATIENTS FROM THE NATIONAL READMISSION DATABASE (NRD) WHO UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WHERE WATCHMAN CLOSURE DEVICES (WDS) WERE IMPLANTED (BRAND NAME OF WDS WAS NOT REPORTED) AND WATCHMAN ACCESS SYSTEMS (WAS) WERE MOST LIKELY UTILIZED FOR GROIN ACCESS (BRAND NAME OF WAS NOT REPORTED). OUT OF THESE GROUPS, 0.65% AND 0.62% WERE RENAL AND LIVER TRANSPLANT RECIPIENTS IN NIS AND NRD RESPECTIVELY. THE PRIMARY STUDY ENDPOINT WAS MAJOR COMPLICATIONS IN BOTH WITHOUT TRANSPLANT AND ALSO WITH TRANSPLANT GROUPS. IT WAS REPORTED THAT THE FOLLOWING EVENTS OCCURRED IN EITHER GROUP: PERICARDIAL EFFUSION REQUIRING INTERVENTION, ISCHEMIC AND HEMORRHAGIC STROKE, TRANSIENT ISCHEMIC ATTACK, HEART BLOCK, CARDIAC ARREST, PERCUTANEOUS CORONARY INTERVENTION, ST ELEVATION MYOCARDIAL INFARCTION, PERICARDITIS, CARDIOGENIC SHOCK, RESPIRATORY FAILURE, PLEURAL EFFUSION, PNEUMOTHORAX, PNEUMONIA BACTERIAL NEED FOR A VENTILATOR, ACUTE KIDNEY INJURY (AKI) AND SOME AKI REQUIRING DIALYSIS. SOME PATIENTS REQUIRED READMISSION TO THE HOSPITAL. FOR EVENTS POSSIBLY RELATED TO THE WAS DEVICES, THE FOLLOWING EVENTS OCCURRED: AV FISTULA, PSEUDOANEURYSM, HEMATOMA, RETROPERITONEAL BLEEDING, VENOUS THROMBOEMBOLISM, GASTROINTESTINAL BLEEDING, INTRAPROCEDURAL BLEEDING, NEED FOR BLOOD TRANSFUSION. LITERATURE CITATION: ZAHID, S. ET AL (NOVEMBER 2022). TRENDS AND OUTCOMES OF LEFT ATRIAL APPENDAGE OCCLUSION IN RENAL AND LIVER TRANSPLANT. CURRENT PROBLEMS IN CARDIOLOGY 48(2):101488. DOI: 10.1016/J.CPCARDIOL.2022.101488.

Description of Event or Problem · 0

REPORTED VIA JOURNAL ARTICLE: IT WAS REPORTED THAT SERIOUS INJURIES OCCURRED. THE FOLLOWING EVENT WAS OBTAINED VIA A RETROSPECTIVE ARTICLE FOLLOWING 61,995 PATIENTS FROM THE NATIONAL INPATIENT SAMPLE (NIS) AND 55,048 PATIENTS FROM THE NATIONAL READMISSION DATABASE (NRD) WHO UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WHERE WATCHMAN CLOSURE DEVICES (WDS) WERE IMPLANTED (BRAND NAME OF WDS WAS NOT REPORTED) AND WATCHMAN ACCESS SYSTEMS (WAS) WERE MOST LIKELY UTILIZED FOR GROIN ACCESS (BRAND NAME OF WAS NOT REPORTED). OUT OF THESE GROUPS, 0.65% AND 0.62% WERE RENAL AND LIVER TRANSPLANT RECIPIENTS IN NIS AND NRD RESPECTIVELY. THE PRIMARY STUDY ENDPOINT WAS MAJOR COMPLICATIONS IN BOTH WITHOUT TRANSPLANT AND ALSO WITH TRANSPLANT GROUPS. IT WAS REPORTED THAT THE FOLLOWING EVENTS OCCURRED IN EITHER GROUP: PERICARDIAL EFFUSION REQUIRING INTERVENTION, ISCHEMIC AND HEMORRHAGIC STROKE, TRANSIENT ISCHEMIC ATTACK, HEART BLOCK, CARDIAC ARREST, PERCUTANEOUS CORONARY INTERVENTION, ST ELEVATION MYOCARDIAL INFARCTION, PERICARDITIS, CARDIOGENIC SHOCK, RESPIRATORY FAILURE, PLEURAL EFFUSION, PNEUMOTHORAX, PNEUMONIA BACTERIAL NEED FOR A VENTILATOR, ACUTE KIDNEY INJURY (AKI) AND SOME AKI REQUIRING DIALYSIS. SOME PATIENTS REQUIRED READMISSION TO THE HOSPITAL. FOR EVENTS POSSIBLY RELATED TO THE WAS DEVICES, THE FOLLOWING EVENTS OCCURRED: AV FISTULA, PSEUDOANEURYSM, HEMATOMA, RETROPERITONEAL BLEEDING, VENOUS THROMBOEMBOLISM, GASTROINTESTINAL BLEEDING, INTRAPROCEDURAL BLEEDING, NEED FOR BLOOD TRANSFUSION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2069882		SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL	NGV	BOSTON SCIENTIFIC CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention\| O\| H