BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 22631000 · Received July 28, 2025

    Report

    Report Number
    2124215-2025-50317
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    January 12, 2025
    Report Date
    July 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY. IT WAS REPORTED A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED ON (B)(6) 2024, AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 21.2 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON APIXABAN AND ASPIRIN. ON (B)(6) 2025, 186 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED SLURRED SPEECH AND A BRIEF LACK OF HAND CONTROL ON THE RIGHT SIDE AND PRESENTED TO EMERGENCY DEPARTMENT THROUGH EMERGENCY MEDICAL SERVICES. HOWEVER, PRIOR TO THE ARRIVAL TO EMERGENCY DEPARTMENT THESE SYMPTOMS WERE RESOLVED. AT THE TIME OF REPORTING, THE PATIENT WAS NOT ON ASPIRIN MEDICATION. BRAIN IMAGING, COMPUTED TOMOGRAPHY (CT) SCAN, LAB TEST AND ELECTROCARDIOGRAM WERE PERFORMED. ALL THE IMAGING PERFORMED WERE NEGATIVE FOR STROKE. BASED ON THE SYMPTOMS AND DIAGNOSTIC FINDINGS THE PATIENT WAS DIAGNOSED WITH TIA. THE PATIENT WAS RESTARTED WITH CLOPIDOGREL MEDICATION. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION WITH FOLLOW UP VISIT AS AN OUTPATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455566 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 0034044938 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Other