BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 8848587 · Received July 31, 2019

    Report

    Report Number
    2134265-2019-09069
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    August 30, 2018
    Report Date
    July 31, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. ON (B)(6) 2019 THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WAS SUCCESSFULLY IMPLANTED WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 24.1MM. PRIOR TO THE INDEX PROCEDURE, 81 MG ASPIRIN AND 5 MG OF APIXABAN ADMINISTERED. ON THE DAY OF PROCEDURE, THE PATIENT WAS DIAGNOSED WITH PERICARDIAL EFFUSION, SUSPECTED CAUSE HAS BEEN NOTED AS VOLUME OVERLOADING. ON THE SAME DAY, THE PATIENT WAS ALSO DIAGNOSED WITH ACUTE RESPIRATORY FAILURE (RESPIRATORY FAILURE WITH HYPOXIA), HEMATOMA/ ECCHYMOSIS. ON (B)(6) 2018, THE PATIENT HAD THROMBOCYTOPENIA (PLATELET COUNT DROP). THE PATIENT WAS MEDICALLY TREATED IN RESPONSE TO ACUTE RESPIRATORY FAILURE, THROMBOCYTOPENIA AND PERICARDIAL EFFUSION. THE HEMATOMA/ECCHYMOSIS WAS TREATED WITH COMPRESSION (MANUAL, SANDBAG, BANDAGE, ETC.). ON (B)(6) 2018, THE PATIENT WAS DISCHARGED ON ASPIRIN AND APIXABAN AND THE EVENTS WERE CONSIDERED RESOLVED. ON (B)(6) 2018, 45 DAYS FOLLOW-UP TEE REVEALED COMPLETE SEAL WITH 50% LVEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641903 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10393 0021732169

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention