BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 22984004 · Received September 5, 2025

    Report

    Report Number
    2124215-2025-62532
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004590
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED. DURING A ROUTINE 4 MONTH FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) A LARGE THROMBUS WAS NOTED ON THE FACE OF THE CLOSURE DEVICE. THE PATIENT HAD BEEN ON HALF DOSE ELIQUIS FOR THREE (3) MONTHS WITH ASPIRIN AND HAD DISCONTINUE ORAL ANTICOAGULATION (OAC) AT THE TIME OF THE TEE. THE PLAN IS TO RESTART OAC AND REPEAT A TEE IN THREE (3) MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305947 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60240 0035941701 00191506004590

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Other