BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18912279 · Received March 15, 2024

    Report

    Report Number
    2124215-2024-14429
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    January 8, 2024
    Report Date
    March 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE HEAL-LAA STUDY WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT PERICARDIAL EFFUSION (PE) OCCURRED. ON (B)(6) 2023, A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED WITH A SUCCESSFUL PLACEMENT OF A 27 MM WATCHMAN FLX PRO LAAC CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 23.9MM. THE NEXT DAY THE PATIENT WAS DISCHARGED ON APIXABAN AND ASPIRIN. ON (B)(6) 2024, 56 DAYS POST IMPLANT PROCEDURE, THE PATIENT PRESENTED FOR THE 45-DAY FOLLOW-UP VISIT. COMPUTED TOMOGRAPHY WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION (PE) MEASURING 3.4MM. A PERICARDIOCENTESIS WAS PERFORMED AND A PERICARDIAL DRAIN WAS PLACED. THE ETIOLOGY OF THE PERICARDIAL EFFUSION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265969 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6027 0031891623 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention