BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19341554 · Received May 17, 2024

    Report

    Report Number
    2124215-2024-28994
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    May 9, 2024
    Report Date
    May 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND A 27MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING. THE PATIENT WAS PLACED ON PLAVIX AND ASPIRIN MEDICATION FOR ORAL ANTICOAGULATION (OAC) POST PROCEDURE FOR A PLANNED TIME OF THREE (3) MONTHS. AT THE THREE (3) MONTH ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED A NORMAL RESULT. THE PHYSICIAN TOOK THE PATIENT OFF OF PLAVIX. AT THE SIX (6) MONTH ROUTINE FOLLOW UP, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING REVEALED A DEVICE RELATED THROMBUS. THE PHYSICIANS PLANNED TO CHANGE THE OAC REGIMEN IN RESPONSE TO THE DRT. THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519880 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0032277678 08714729860501

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other