BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 1358735 · Received April 7, 2009

    Report

    Report Number
    3003761017-2009-00017
    Event Type
    Death
    Date Received
    April 7, 2009
    Date of Event
    March 15, 2009
    Report Date
    April 7, 2009
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SYNCARDIA HAS REQUESTED THAT THE EXPLANTED TAH-T BE RETURNED FOR EVAL, AND THE RESULTS WILL BE REPORTED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    A DR REPORTED A DEATH OF PT WHO WAS SUPPORTED BY THE CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T). SYNCARDIA'S PRINCIPAL INVESTIGATOR, ANOTHER DR SPOKE TO DR(REPORTER) ABOUT THE PT'S DEATH. DR(SECOND) REPORTED THAT DR(REPORTER) STATED THAT THE PT WAS NON-COMPLIANT AND WOULD NOT TAKE HIS ANTICOAGULATION MEDICATIONS. IN THE ABSENCE OF ANY ANTICOAGULATION, THE OUTFLOW VALVE OF THE TAH-T LEFT VENTRICLE OCCLUDED. PUMP FLOWS ON THE LEFT DECREASED MARKEDLY, AND AN EARLY LEFT VENTRICULAR FULL FILLING PATTERN WAS OBSERVED SHORTLY BEFORE THE OUTPUT OF THE LEFT SIDE WENT TO ZERO. THE RIGHT SIDE CONTINUED TO PUMP, AND THE PT WAS FOUND TO HAVE PULMONARY EDEMA ON CHEST X-RAY. WHEN THE TAH-T WAS EXPLANTED, A LARGE THROMBUS WAS FOUND ON THE OUTFLOW VALVE. THE SYNCARDIA TAH-T EXPLANT FORM, COMPLETED AT THE HOSPITAL, HAS A NOTATION STATING. "THROMBUS ADHERED TO EJECTION VALVES OF LEFT AND RIGHT VENTRICLES. THE PT REFUSED TO TAKE HIS ANTICOAGULATION DRUGS." PATIENTS WHO ARE IMPLANTED WITH THE TAH-T REQUIRE SYSTEMIC ANTICOAGULATION. THE SYNCARDIA CARDIOWEST TAH-T INSTRUCTIONS FOR USE, CONTRAINDICATIONS, STATES AS FOLLOWS: "THE CARDIOWEST TAH-T IS CONTRAINDICATED FOR USE IN...PATIENTS WHO CANNOT BE ADEQUATELY ANTICOAGULATED ON THE TAH-T."

    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 65784

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR