BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS.

    MDR report key: 3161722 · Received June 6, 2013

    Report

    Report Number
    3003502395-2013-00008
    Event Type
    Death
    Date Received
    June 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K093679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED FAILURE OF THE DEVICE BY MEDICAL PERSONNEL AND THEREFORE, THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND THERE WERE NO NON-CONFORMANCE OR REWORKS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE IFU DOES ISSUE A PRECAUTION REGARDING THE PLACEMENT OF THE CLIP IF A THROMBUS IS PRESENT.

    Description of Event or Problem · 1

    AFTER COMPLETION OF A CORONARY ARTERY BYPASS GRAFT THE PATIENT WAS TAKEN OFF BYPASS AND THE SURGEON PLACED A CLIP ON THE LAA. AN INTRA-OPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED AND IT WAS NOTICED THAT THERE WAS A THROMBUS INSIDE THE LEFT ATRIUM. THROMBUS ASPIRATION WAS PERFORMED AND THE SIZE WAS REDUCED FROM 1CM TO 0.25 - 0.5 CM. THE PATIENT REMAINED UNDER UNTIL THE NEXT DAY (1 DAY POST-OP) AT WHICH TIME UPON WAKING UP THE PATIENT IT WAS DISCOVERED THAT THE PATIENT HAD SUFFERED A STROKE AND THE ENTIRE LEFT SIDE OF THE BRAIN WAS BLOCKED. THE PATIENT EXPIRED ON (B)(6) 2013 (20 DAYS POST-OP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251290 ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION SYS. CLIP, IMPLANTABLE FZP ATRICURE, INC. ACH140 43488

    Patients

    Seq Age Sex Outcome Treatment
    1 Death