BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18867719 · Received March 8, 2024

    Report

    Report Number
    2124215-2024-13358
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    July 13, 2023
    Report Date
    March 8, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLOSURE DEVICE DID NOT SEAL. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 35MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. AT THE ONE-YEAR FOLLOW-UP APPOINTMENT, A LEAK WAS IDENTIFIED VIA COMPUTED TOMOGRAPHY (CT). THE LEAK APPEARED TO BE 2MM IN SIZE. THE LEAK WAS LATER COILED ON (B)(6) 2024, TO CLOSE THE SMALL LEAK ON THE MITRAL SIDE OF THE CLOSURE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194397 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027099678 08714729860525

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention