BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 1472678 · Received September 11, 2009

    Report

    Report Number
    3003761017-2009-00039
    Event Type
    Death
    Date Received
    September 11, 2009
    Date of Event
    September 7, 2009
    Report Date
    September 11, 2009
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH THE CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) IN 2007. THE PT WAS ON THE HIGH URGENT LIST FOR A HEART TRANSPLANT. HE WAS SUPPORTED BY A SYNCARDIA EXCOR TAH-T PORTABLE PNEUMATIC DRIVER. AT APPROX 9 WEEKS POST-OP, SENIOR SURGEON, REPORTED THAT PT LOST CONSCIOUSNESS, AND WAS BROUGHT TO THE INTENSIVE CARE UNIT AT THE HEART CENTER. HE REPORTED THAT THE EXCOR DRIVER EXHIBITED ALARMS, AND THE PT HAD MASSIVE LUNG EDEMA AND UNMEASURABLE BLOOD PRESSURE. THE PT WAS SWITCHED TO A CSS CONSOLE, AND A FEMORAL VENOUS-ARTERIAL ECMO WAS IMPLANTED, WITHOUT SUCCESS. THE PT EXPIRED. CARDIOWEST TAH-T LOT 63815 WAS EXPLANTED IN THE NEXT DAY, AND WILL BE SENT TO SYNCARDIA FOR INVESTIGATION. THE RESULTS WILL BE REPORTED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART DSQ SYNCARDIA SYSTEMS, INC. TAH-T 63815

    Patients

    Seq Age Sex Outcome Treatment
    1 Death