BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA FLX CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 15882606 · Received November 29, 2022

    Report

    Report Number
    2124215-2022-49471
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    November 2, 2022
    Report Date
    November 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: PUBLICATION DATE OF 02NOV2022 USED AS EVENT DATE IS UNKNOWN. VUKOMANOVIC, D. ET AL. (2022). MASSIVE DEVICE-RELATED THROMBUS AFTER LAA OCCLUSION INTRAOPERATIVE INSIGHTS INTO MECHANISM. JOURNALS OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOLUME 4 (ISSUE 21), 1409-1413.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). SIX (6) MONTHS POST INDEX PROCEDURE, ANTI-COAGULATION AND DUAL ANTIPLATELET THERAPIES WERE DISCONTINUED, AND ASPIRIN WAS INITIATED. AT AN UNSPECIFIED TIME POST INDEX PROCEDURE, THE PATIENT REPORTED PROGRESSIVE DYSPNEA ON EXERTION. DURING AN ECHOCARDIOGRAPHIC EVALUATION, PROGRESSION OF CARDIAC VALVULAR DISEASE WAS DISCOVERED. TWENTY-SIX (26) MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT, MITRAL VALVE REPAIR, AND A COX MAZE IV PROCEDURE. DURING THIS PROCEDURE, A THROMBUS MEASURING 2.5CM BY 2.5CM WAS DISCOVERED ON THE SURFACE OF THE CLOSURE DEVICE IN THE CEPHALAD POSITION. A THROMBECTOMY WAS PERFORMED. THE CENTRAL SCREW HUB OF THE CLOSURE DEVICE WAS OBSERVED TO NOT HAVE ENDOTHELIALIZED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464289 WATCHMAN LAA FLX CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention