BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 22185835 · Received June 11, 2025

    Report

    Report Number
    2124215-2025-38213
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004583
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    B3: AWARE DATE WAS USED AS EVENT DATE AS ACTUAL EVENT DATE WAS NOT KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS DISCHARGED. DURING A ROUTINE FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN AN IMMOBILE, DEVICE RELATED THROMBUS (DRT) WAS NOTED ON THE FACE OF THE CLOSURE DEVICE. THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY AT THE TIME OF THE EVENT. THE PATIENT WILL CONTINUE ON ORAL ANTICOAGULATION (OAC). THE PATIENT IS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102360 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60200 0035639840 00191506004583

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other