BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19392306 · Received May 24, 2024

    Report

    Report Number
    2124215-2024-31625
    Event Type
    Injury
    Date Received
    May 24, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: ESTIMATED AS 04/02/22024 AS THE ONLINE PUBLISHED DATE FOR THE ARTICLE IS NOTED AS 2 APRIL 2024. CITATION: DHALIWAL, S., TAO, M., GIER, C., KIM, P.M., MALEKI, N.D., NOVOTNY, H.S., BENSON, D., RASHBA, E.J., MANN, N.N. & KORT, S. (2024). INTRADEVICE LEAK: A RARE BUT IMPORTANT COMPLICATION AFTER LEFT ATRIAL APPENDAGE OCCLUSION, JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOLUME 83, ISSUE 13, SUPPLEMENT A, PAGE 2886. ISSN 0735-1097. HTTPS://DOI.ORG/10.1016/S0735-1097(24)04876-9. HTTPS://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S0735109724048769).

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED A CLOSURE DEVICE DID NOT SEAL. A 71-YEAR-OLD FEMALE WITH ATRIAL FIBRILLATION (AF) UNDERWENT 24MM WATCHMAN FLX LAA CLOSURE DEVICE IMPLANTATION GIVEN HISTORY OF SUBDURAL HEMATOMA REQUIRING EVACUATION. THERE WAS NO INITIAL LEAK AFTER IMPLANT. 45 DAYS POST-IMPLANTATION, TRANSESOPHAGEAL ECHOCARDIOGRAPHY DEMONSTRATED A 2.1 MM INTRADEVICE LEAK (IDL) WITH BIDIRECTIONAL FLOW ADJACENT TO A WELL SEATED DEVICE, AND A SMALL DISCONTINUITY. AFTER MULTIDISCIPLINARY SHARED DISCUSSION WITH THE PATIENT, THE PATIENT WAS CONTINUED ON ANTIPLATELET AGENTS AND REINITIATED ON ORAL ANTICOAGULATION (OAC) MEDICATION WITH CLOSE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320456 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other