BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    MDR report key: 23109386 · Received September 22, 2025

    Report

    Report Number
    2124215-2025-66158
    Event Type
    Death
    Date Received
    September 22, 2025
    Date of Event
    November 1, 2022
    Report Date
    September 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 THE LITERATURE ARTICLE DATE, AS THE EVENT DATES ARE UNKNOWN. D1: BRAND NAME IS BLANK BECAUSE THE DEVICE IS KNOWN TO BE A WATCHMAN LAA CLOSURE 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 DEATHS 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: DIED DURING HOSPITALIZATION (95 PATIENTS WITHOUT TRANSPLANT, 0 PATIENTS WITH TRANSPLANT), AND DIED AT READMISSION (96 PATIENTS WITHOUT TRANSPLANT, 0 PATIENTS WITH TRANSPLANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026554 SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death