BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 20183057 · Received September 10, 2024

    Report

    Report Number
    2124215-2024-56216
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON AN ORAL ANTICOAGULATION MEDICATION (OAC) REGIMEN. AT THE 6 WEEK ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING REVEALED A DEVICE RELATED THROMBUS (DRT) ON THE FACE OF THE CLOSURE DEVICE. THE PHYSICIANS CONTINUED THE OAC REGIMEN IN RESPONSE TO THE DRT. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WILL BE REIMAGED IN SIX WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223693 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6024 0033637487 00191506004590

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention