BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19637582 · Received June 28, 2024

    Report

    Report Number
    2124215-2024-39728
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 21, 2024
    Report Date
    June 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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. THE PATIENT WAS PLACED ON AN ORAL ANTICOAGULANT (OAC) REGIMEN. AT THE 45-DAY ROUTINE FOLLOW UP, IMAGING REVEALED A DEVICE RELATED THROMBUS (DRT). THE PATIENT REPORTED REFUSING TAKING THE OAC FOR ALL 45 DAYS POST INDEX PROCEDURE. THE PHYSICIANS PLACED THE PATIENT ON OAC IN RESPONSE TO THE DRT. NO FURTHER INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292880 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6035 00191506004620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other