BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 23425915 · Received October 30, 2025

    Report

    Report Number
    2124215-2025-77896
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004620
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 35MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. A CORE LAB REVIEW OF THE 45-DAY FOLLOW-UP IMAGING IDENTIFIED A GRADE 1 DEVICE RELATED THROMBUS. NO CORRECTIVE ACTIONS OR DIAGNOSTIC TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297233 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60350 0035919736 00191506004620

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other