BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 3800176 · Received May 1, 2014

    Report

    Report Number
    3003761017-2014-00068
    Event Type
    Death
    Date Received
    May 1, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 1, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED TAH-T WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE EVALUATION IS IN PROCESS, AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PATIENT 10 WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) AT (B)(6) ON (B)(6) 2014, SUPPORTED BY A COMPANION 2 DRIVER. THE CUSTOMER REPORTED THAT ON (B)(6) 2014, THE PATIENT HAD A MASSIVE STROKE. AS A RESULT, SUPPORT WAS WITHDRAWN AND THE PATIENT EXPIRED. THE CUSTOMER REPORTED THAT THE PATIENT HAD NO SIGNS OF INFECTION, WAS STABLE BUT ALWAYS HAD HIGH FLOWS BECAUSE OF THE PATIENT'S LARGE SIZE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT EXERCISED BY WALKING IN THE PARK AND ACCORDING TO THE CLINICAL TEAM, THE PATIENT'S COAGULATION WAS WELL CONTROLLED AND HIS PARAMETERS WERE IN NORMAL RANGE, SO THE REASON FOR THE PATIENT'S STROKE WAS NOT CLEAR. THE CUSTOMER RETURNED THE EXPLANTED TAH-T AND REQUESTED THAT SYNCARDIA PERFORM AN EVALUATION. AT THIS TIME, THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261901 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 086137

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death