BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19410033 · Received May 28, 2024

    Report

    Report Number
    2124215-2024-31634
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    May 9, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE HEAL-LAA STUDY ON (B)(6) 2024 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THE DEVICE DID NOT SEAL, AND THROMBOSIS OCCURRED. ON (B)(6) 2024, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 40MM WATCHMAN FLX PRO DEVICE WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 34 MM. THE PREVIOUS IMAGING PERFORMED POST INDEX PROCEDURE ON (B)(6) 2024 REVEALED NO INTRACARDIAC AND LEFT ATRIAL APPENDAGE THROMBUS AND A COMPLETE SEAL WAS NOTED POST INDEX PROCEDURE. ON (B)(6) 2024, 48 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL SCHEDULED 45-DAY FOLLOW-UP. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING ASSESSMENT WAS PERFORMED WHICH REVEALED A 0.6 CM NON-MOBILE THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX PRO DEVICE AND 5MM RESIDUAL JET WAS NOTED AROUND THE DEVICE. NO INTERVENTIONS WERE PERFORMED TO CLOSE THE LEAK. THE PATIENT MEDICATION REGIMEN WAS CHANGED FROM DUAL ANTIPLATELET THERAPY TO ANTICOAGULATION MEDICATION (ELIQUIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299084 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6040 0032622140

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other