BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 14473802 · Received May 23, 2022

    Report

    Report Number
    2134265-2022-05779
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    May 13, 2022
    Report Date
    May 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEVICE MOVEMENT AND DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED USING A WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS DISCHARGED. ON (B)(6) 2022, 158 DAYS POST PROCEDURE, DURING A ROUTINE FOLLOW-UP EXAMINATION IT WAS DISCOVERED THE CLOSURE DEVICE HAD SHIFTED TO A PROXIMAL POSITION WITHIN THE LAA. DUE TO THE DEVICE SHIFT A DEVICE LEAK DEVELOPED. NO INTERVENTIONS WERE PERFORMED AND THE PATIENT IS STABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582539 WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other