BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 19892707 · Received August 2, 2024

    Report

    Report Number
    2124215-2024-47398
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    January 1, 2019
    Report Date
    August 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DID NOT SEAL, AND THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 33MM WATCHMAN CLOSURE DEVICE WAS IMPLANTED (B)(6) 2018. THE PATIENT THEN HAD A SECOND 33MM WATCHMAN CLOSURE DEVICE IMPLANTED (B)(6) 2018. A 3MM LEAK WAS FOUND AFTER IMPLANTING THE SECOND DEVICE AND COILS WERE PLACED IN JANUARY 2019 TO RESOLVE. DURING A ROUTINE FOLLOW UP EXAMINATION TO CHECK ON AN UNRELATED MITRAL ISSUE IN JULY 2024, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING REVEALED A LARGE DEVICE RELATED THROMBUS (DRT) ON THE SECOND 33MM CLOSURE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863469 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0022175293

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other| R