BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 6116429 · Received November 21, 2016

    Report

    Report Number
    2134265-2016-10469
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    UDI-DI
    08714729838227
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 70'S. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR: 2134265-2016-10517. IT WAS REPORTED THAT A PERFORATION AND PERICARDIAL EFFUSION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A 21MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WAS INSERTED INTO THE WATCHMAN ® ACCESS SYSTEM. THE CLOSURE DEVICE WAS DEPLOYED; HOWEVER IT WAS TOO PROXIMAL SO IT WAS FULLY RECAPTURED. IT WAS NOTED THAT PHYSICIAN DID NOT THINK THAT THE FIRST CLOSURE DEVICE CONTRIBUTED TO THE EFFUSION. ANOTHER 21MM WATCHMAN ® LAA CLOSURE DEVICE AND DELIVERY SYSTEM WAS THEN INSERTED INTO THE WATCHMAN ® ACCESS SYSTEM. AFTER THIS CLOSURE DEVICE WAS DEPLOYED, THEY NOTICED FLUID ON THE ECHOCARDIOGRAM AND A SMALL PERICARDIAL EFFUSION WAS NOTED. THEY WATCHED THE PATIENT FOR ABOUT 5 MINUTES AND NOTICED THAT THE EFFUSION WAS GROWING. THEY DECIDED TO PERFORM A PERICARDIOCENTESIS AND DRAINED ABOUT 800ML OF FLUID. THE PATIENT THEN EXPERIENCED A DROP IN BLOOD PRESSURE. SINCE THEY WERE UNSTABLE, THEY DECIDED TO SURGICALLY REPAIR A SMALL TEAR IN THE LAA. IT APPEARED THAT THE TEAR MAY HAVE BEEN CAUSED BY THE FEET OF THE CLOSURE DEVICE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768821 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WU21060 19001353 08714729838227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention