BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19046544 · Received April 4, 2024

    Report

    Report Number
    2124215-2024-19154
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    January 1, 2021
    Report Date
    April 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED BASED OFF PUBLICATION DATE OF ARTICLE. LITERATURE CITATION: THAKKER, R. ET AL, (MAY 11, 2021). RCA THROMBOEMBOLISM FOLLOWING LEFT ATRIAL APPENDAGE CLOSURE. JOURNAL OF AMERICAN COLLEGE OF CARDIOLOGY, VOL. 77(18), 2486. HTTPS://DOI.ORG/10.1016/S0735-1097(21)03841-9.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT STROKE AND THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED, AND A WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. TWO AND A HALF MONTHS POST-IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ACUTE ONSET RIGHT HAND WEAKNESS. IMAGING CONFIRMED AN ANTERIOR CIRCULATION STROKE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED AND IDENTIFIED A 1X2CM THROMBUS IN THE LEFT ATRIUM. WARFARIN WAS RESUMED. ONE MONTH LATER THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH DIZZINESS AND FOUND TO HAVE JUNCTIONAL BRADYCARDIA. CORONARY ANGIOGRAM WAS PERFORMED WHICH IDENTIFIED A RIGHT CORONARY ARTERY THROMBUS. MANUAL ASPIRATION TO RETRIEVE THE THROMBUS WAS UNSUCCESSFUL AND THE PATIENT UNDERWENT DRUG-ELUTING STENT ACROSS THE THROMBUS. THE PATIENT WAS RESUMED ON WARFARIN AND STARTED CLOPIDOGREL UPON DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58184 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other