BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19833279 · Received July 25, 2024

    Report

    Report Number
    2124215-2024-46166
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    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 WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON PLAVIX AND ASPIRIN ORAL ANTICOAGULANT (OAC) MEDICATION REGIMEN. AT THE 45-DAY ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A VERY LARGE DEVICE RELATED THROMBUS (DRT). THE PATIENT HAD REPORTED BEING COMPLIANT WITH THE PRESCRIBED OAC REGIMEN. THE PHYSICIANS SWITCHED THE MEDICATION TO ELIQUIS. RE-IMAGING WAS PERFORMED ONE MONTH LATER, AND THE DRT WAS STILL PRESENT BUT GREATLY DIMINISHED. THE PATIENT WILL STAY ON THE OAC REGIMEN AND WILL BE RE-IMAGED IN A COUPLE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188123 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other