BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

    MDR report key: 22680819 · Received July 31, 2025

    Report

    Report Number
    2124215-2025-50311
    Event Type
    Death
    Date Received
    July 31, 2025
    Date of Event
    July 23, 2025
    Report Date
    July 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: USED BSC AWARE DATE AS EVENT DATE AS IT IS 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

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT DEATHS OCCURRED. THE FOLLOWING EVENT WAS OBTAINED VIA A RETROSPECTIVE ARTICLE OF THREE (3) YEAR OUTCOMES FROM FOLLOWING 220 PATIENTS WHO UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WHERE EITHER A NON-BOSTON SCIENTIFIC LAA CLOSURE DEVICE, A WATCHMAN CLOSURE DEVICE, OR A WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED ACROSS EIGHT (8) CENTERS. THIS WAS A RANDOMIZED CONTROL TRIAL. IT WAS REPORTED THE FOLLOWING OCCURRED AND RESULTS WERE COMPILED AT THE THREE (3) YEAR CLINICAL FOLLOW UP: PATIENT CARDIOVASCULAR DEATH. LITERATURE CITATION: GALEA, R. ET AL 2025) 3-YEAR CLINICAL OUTCOMES COMPARING THE AMULET VS WATCHMAN FLX FOR LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH ATRIAL FIBRILLATION. 86 (1). JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198435 SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death