BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 23378591 · Received October 24, 2025

    Report

    Report Number
    2124215-2025-76356
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON ASPIRIN AND CLOPIDOGREL. AFTER (B)(6) 2025, THE PATIENT WAS CHANGED TO APIXABAN AND ASPIRIN. AT THE 45-DAY ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING REVEALED A LAMINAR, NON-MOBILE DEVICE RELATED THROMBUS (DRT) IN REGARD TO THE CLOSURE DEVICE. COMPLETE SEAL AROUND THE CLOSURE DEVICE WAS NOTED. THE PHYSICIANS STOPPED THE PATIENTS' PLAVIX MEDICATION AND HAD THE PATIENT RESTART APIXABAN IN RESPONSE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403512 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 0036581493 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention