BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 22197198 · Received June 12, 2025

    Report

    Report Number
    2124215-2025-38848
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 2, 2025
    Report Date
    June 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. 55 DAY ECHOCARDIOGRAM PERFORMED SHOWED THE CLOSURE DEVICE STABLE AT LAA OSTIUM WITH NO LEAK PRESENT. 64 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH BILATERAL TREMULOUSNESS IN UPPER EXTREMITIES, CHEST PAIN, WITH A SUSPECTED STROKE. THE SYMPTOMS LASTED SEVERAL HOURS. BY THE TIME THE DIAGNOSTICS (LABS, COMPUTED TOMOGRAPHY (CT) SCAN, AND MAGNETIC RESONANCE IMAGING (MRI) SCAN) WERE FINISHED, SYMPTOMS DISSIPATED. THE PHYSICIANS SAW EVIDENCE OF A TRANSIENT ISCHEMIC ATTACK (TIA) AND NOT A STROKE. MRI RESULTS SHOWED NO ACUTE INFARCTION, HEMORRHAGE, OR INTRACRANIAL MASS LESION. AT THE TIME OF THE EVENT, THE PATIENT WAS STILL ON RIVAROXABAN. THE PATIENT HAD A ORAL MEDICATION CHANGE/ADJUSTMENT OTHER THAN ANTITHROMBOTIC, PERFORMED AS THE CORRECTIVE ACTION TO THE EVENT. THE PATIENT SPENT TWO (2) NIGHTS ADMITTED TO THE HOSPITAL AND THEN WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033354 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 0035473154 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Hospitalization| R