BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19271840 · Received May 8, 2024

    Report

    Report Number
    2124215-2024-26862
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 8, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004590
    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 THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING GUIDANCE AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON AN ORAL ANTICOAGULANT (OAC) MEDICATION REGIMEN. AT THE 45-DAY ROUTINE FOLLOW UP, COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED A DEVICE RELATED THROMBUS (DRT). THE PATIENT HAD REPORTED BEING COMPLIANT WITH THE PRESCRIBED OAC REGIMEN, SO THE PHYSICIANS RECOMMENDED THE PATIENT CONTINUE ON OAC. NO FURTHER INTERVENTIONS WERE REPORTED. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782174 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6024 0032561277 00191506004590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other