BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 8312804 · Received February 6, 2019

    Report

    Report Number
    2134265-2019-00855
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    January 1, 2018
    Report Date
    February 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GYOTEN T, GRIMMIG O, JUST S, FRITZSCHE D. SURGICAL REPAIR OF AN UNCONTROLLED THROMBUS CAUSED BY THE WATCHMAN DEVICE. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 2019; 28:164-6. DATE OF EVENT: UNKNOWN, THEREFORE THE DATE WAS APPROXIMATED BASED ARTICLE DATES.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE IT WAS REPORTED THAT DEVICE RELATED THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. DURING A ROUTINE ONE YEAR FOLLOW UP TRANSTHORACIC ECHOCARDIOGRAM (TTE), THROMBUS WAS NOTED ON THE THREADED INSERT. THE PATIENT HAD BEEN ON APIXABAN FOR FIVE MONTHS. HOWEVER, BECAUSE OF FREQUENT STROKE, THE SURGICAL REMOVAL OF THE THROMBUS WAS ELECTIVELY PERFORMED USING A RIGHT THORACOTOMY APPROACH AS THE STANDARD METHOD. THE FACE OF THE WATCHMAN DEVICE WAS COMPLETELY ENDOTHELIALIZED EXCEPT FOR THE THREADED INSERT WHICH THE THROMBUS ORIGINATED FROM. THE THROMBUS WAS REMOVED AND THE LAA ORIFICE, INCLUDING THE WATCHMAN, WAS EXCLUDED FROM THE LA SIDE USING AN AUTOLOGOUS PERICARDIAL PATCH. THE POST OPERATIVE COURSE WAS UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103148 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention