BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX?

    MDR report key: 23768361 · Received December 10, 2025

    Report

    Report Number
    2124215-2025-90117
    Event Type
    Death
    Date Received
    December 10, 2025
    Date of Event
    November 28, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860501
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY: IT WAS REPORTED THAT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. PRIOR TO IMPLANT PROCEDURE, ASPIRIN WAS ADMINISTERED. ON (B)(6) 2022, THE PATIENT UNDERWENT SUCCESSFUL PLACEMENT OF 27 MM WATCHMAN FLX DEVICE. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON APIXABAN (10 MG/DAY), CLOPIDOGREL (75 MG/DAY) AND ASPIRIN (81 MG/DAY). ON (B)(6) 2025, 1353 DAYS POST INDEX PROCEDURE, THE PATIENT PASSED AWAY. PER EDC, THE HOME HEALTH COMPANY WAS UNABLE TO REACH THE PATIENT BY PHONE OR EMAIL SINCE (B)(6) 2025, SO THEY CONTACTED THE LOCAL POLICE DEPARTMENT TO REQUEST A WELLNESS CHECK ON THE PATIENT AND THE POLICE FOUND THE PATIENT DECEASED INSIDE HOME. AT THE TIME OF DEATH, THE PATIENT WAS ON ASPIRIN (81MG/DAY). THERE WAS NO ACTION TAKEN AND DIAGNOSTICS PERFORMED IN RESPONSE TO THE EVENT. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE, AND SITE HAS BEEN QUERIED FOR THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876381 WATCHMAN FLX? SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU50270 08714729860501

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death