BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 8493797 · Received April 8, 2019

    Report

    Report Number
    2134265-2019-02964
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 11, 2019
    Report Date
    April 8, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729838258
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THROMBUS ON THE CLOSURE DEVICE OCCURRED. ON (B)(6) 2019, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 30MM WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO LEAK NOTED AT 0, 45 AND 90 DEGREES, BUT A SMALL LEAK OF 1MM WAS NOTED AT THE 135 DEGREE VIEW, WHICH IS STILL WITHIN ACCEPTABLE LIMITS. IT WAS ALSO NOTED THAT THERE WAS SMOKE IN THE LA DURING THE PROCEDURE, BUT NO CLOT WAS PRESENT IN THE LA OR LAA. THE RELEASE CRITERIA WERE MET AND THE CLOSURE DEVICE WAS RELEASED. THE PATIENT WAS ON ASPIRIN AND PLAVIX. ON (B)(6) 2019, THE PATIENT CAME IN FOR THEIR ROUTINE FOLLOW UP TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND HAD NO SYMPTOMS. DURING THE TTE, A THROMBUS WAS SEEN ON THE CLOSURE DEVICE. THERE WAS NO CHANGE IN THE POSITIONING OF THE DEVICE. THE PHYSICIAN SWITCHED THE PATIENT'S MEDICATION TO ELIQUIS. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY AND WILL HAVE ANOTHER FOLLOW UP TTE IN APPROXIMATELY EIGHT WEEKS TO MONITOR THE THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286902 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10371 0021772578 08714729838258

    Patients

    Seq Age Sex Outcome Treatment
    1 Other