BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16877342 · Received May 5, 2023

    Report

    Report Number
    2124215-2023-20569
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    January 8, 2023
    Report Date
    May 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHAMPION AF STUDY. IT WAS REPORTED A CEREBRAL VASCULAR ACCIDENT OCCURRED. IN (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). IN (B)(6) 2023, 250 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH EXPRESSIVE APHASIA, SLURRED SPEECH, LOSS OF SPEECH, TROUBLE WITH VISION, HEADACHE, AND DIZZINESS. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF HEAD AND NECK WITH CONTRAST NOTED NO HEMODYNAMICALLY SIGNIFICANT STENOSIS IN THE LARGE VESSEL INTRACRANIAL ARTERIAL VASCULATURE AND NECK ARTERIAL VASCULATURE. COMPUTED TOMOGRAPHY (CT) OF THE HEAD WITHOUT CONTRAST SHOWED MILD GLOBAL ATROPHY AND EXTENSIVE CHRONIC SMALL VESSEL ISCHEMIC CHANGES IN THE WHITE MATTER. ONE DAY POST ADMITTANCE TO THE HOSPITAL, MAGNETIC RESONANCE IMAGING (MRI) OF THE HEAD WITHOUT CONTRAST INDICATED ACUTE CORTICAL INFARCTION OF THE LATERAL POSTERIOR LEFT FRONTAL LOBE, SMALL SUBCORTICAL LACUNAR TYPE INFARCTION OF THE SUPERIOR LEFT OCCIPITAL LOBE, AND MODERATE CHANGES OF CHRONIC MICROANGIOPATHY. TWO DAYS POST ADMITTANCE TO THE HOSPITAL, THE PATIENT WAS PRESCRIBED APIXABAN AND WAS DISCHARGED. SIX DAYS POST DISCHARGE FROM THE HOSPITAL DURING A FOLLOW UP EXAMINATION, THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195846 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0029054066 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other| H