BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 1355744 · Received April 3, 2009

    Report

    Report Number
    3003761017-2009-00016
    Event Type
    Death
    Date Received
    April 3, 2009
    Date of Event
    March 5, 2009
    Report Date
    April 3, 2009
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFECTION AND NEUROLOGICAL EVENTS ARE KNOWN ADVERSE EVENTS FROM THE CLINICAL STUDY, AND ARE LISTED IN THE SYNCARDIA CARDIOWEST TAH-T INSTRUCTIONS FOR USE, AT PAGE 12. SYNCARDIA HAS REQUESTED THAT THE EXPLANTED TAH-T BE RETURNED FOR EVALUATION, AND THE RESULTS WILL BE REPORTED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    DR OF A HOSPITAL REPORTED A DEATH OF PT WHO WAS SUPPORTED BY THE CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T). SYNCARDIA'S PRINCIPAL INVESTIGATOR, DR SPOKE TO DR(REPORTER) ABOUT THE PT'S DEATH. DR(SECOND) REPORTED THAT DR(REPORTER) STATED THAT THE PT, WHO HAD ENTEROCOCCUS PERICARDITIS, WAS TAKEN TO THE OPERATING ROOM FOR PERICARDIAL DRAINAGE. DURING THE COURSE OF THE OPERATION, DR(REPORTER) OBSERVED, ON ELECTROENCEPHALOGRAPHIC MONITORING, THE COMPLETE LOSS OF BRAIN WAVES, SUGGESTING A MASSIVE EMBOLIC STROKE. ON EXAMINATION OF THE TAH-T, DR(REPORTER) REPORTED THAT HE OBSERVED NOTHING TO EXPLAIN A MAJOR THROMBUS. THE SYNCARDIA TAH-T EXPLANT FORM, COMPLETED AT THE HOSPITAL, HAS A NOTATION STATING 'PERICARDIAL THROMBUS AND PROBABLE CEREBRAL ISCHEMIA THAT CAUSED DEATH."

    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 65785

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR