BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2189640 · Received July 29, 2011

    Report

    Report Number
    3003761017-2011-00020
    Event Type
    Death
    Date Received
    July 29, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 27, 2011
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSP VAD COORDINATOR REPORTED THAT A FOUR-INCH VENOUS CLOT WAS OBSERVED IN TAH-T RIGHT VENTRICLE INFLOW VALVE. THE CSS CONSOLE WAS ALSO TESTED IN THE HOSP LAB ON A PT SIMULATOR (B)(4) AND IT PERFORMED AS INTENDED, CONFIRMING THAT THERE WAS NO CSS CONSOLE MALFUNCTION. IT IS POSSIBLE THAT THE PT FORMED A DEEP VEIN THROMBOSIS WHILE BEING SUPPORTED BY AN INTRA-AORTIC BALLOON PUMP (IABP) IN THE TEN DAYS PRIOR TO IMPLANT OF THE TAH-T. THE CLOT THEN MIGRATED AND OBSTRUCTED THE TAH-T INFLOW VALVE. AN INVESTIGATION WILL BE CONDUCTED BY SYNCARDIA, AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6) 2011. THE HOSPITAL REPORTED THAT HE WAS DOING WELL UNTIL (B)(6) 2011, WHEN THE PT SAID HE FELT DIZZY AND THEN LOST CONSCIOUSNESS. THE CIRCULATORY SUPPORT SYSTEM (CSS) CONSOLE THAT WAS SUPPORTING THE TAH-T EXHIBITED FILL VOLUMES OF 8-10 CC. THE DRIVELINES WERE SWITCHED FROM THE PRIMARY CONTROLLER TO THE BACKUP CONTROLLER, AND THERE WAS NO INCREASE IN FILL VOLUME. THE PT WAS SWITCHED TO THE BACKUP CSS CONSOLE, AND THERE WAS NO INCREASE IN FILL VOLUME. THE PT SUBSEQUENTLY EXPIRED. AN AUTOPSY WAS PERFORMED ON (B)(6) 2011, AND PRELIMINARY INFO PROVIDED BY THE HOSP TO SYNCARDIA INDICATED THAT THE PT'S DEATH WAS CAUSED BY PT CONDITIONS AND THAT THERE WAS NO DEVICE MALFUNCTION OF THE TAH-T OR THE CSS CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 068409

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death