BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 20427416 · Received October 11, 2024

    Report

    Report Number
    2124215-2024-63401
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WONG, G., AMAN, E., KIAII, B., ROGERS, J. H., & SINGH, G. D. (2024). TRANSCATHETER EXTRACTION OF A MIGRATED LEFT ATRIAL APPENDAGE OCCLUDER DEVICE. CASE REPORTS, 29(15), 102443. HTTPS://DOI.ORG/10.1016/J.JACCAS.2024.102443. DATE OF EVENT - ARTICLE PUBLISH DATE USED AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT DEVICE MOVEMENT/SHIFT OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT CAME IN FOR THEIR TEN (10) WEEK FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PROCEDURE. THE TEE IMAGING SHOWED THAT THE CLOSURE DEVICE HAD SIGNIFICANTLY MOVED PROXIMALLY. THE PATIENT WAS BROUGHT IN TO UNDERGO A PROCEDURE TO REMOVE THE DEVICE. THE PHYSICIAN SUCCESSFULLY REMOVED THE CLOSURE DEVICE VIA A PERCUTANEOUS APPROACH. THE PATIENT DID WELL FOLLOWING THE PROCEDURE. THIRTY (30) DAYS LATER THE PATIENT HAD A FOLLOW UP APPOINTMENT WHERE THEY WERE NOTED TO BE DOING FINE. THE PATIENT MADE THE DECISION TO REMAIN ON CHRONIC ANTICOAGULATION MEDICATION RATHER THAN UNDERGO ANOTHER LAA CLOSURE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342026 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 69 YR Male Required Intervention