BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 3876275 · Received June 4, 2014

    Report

    Report Number
    3003761017-2014-00075
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SYNCARDIA REQUESTED THAT THE EXPLANTED TAH-T AND RIGHT OUTFLOW CONNECTOR BE RETURNED FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING IMPLANT SURGERY OF THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T), AFTER THE PATIENT WAS TAKEN OFF BYPASS AND PRIOR TO CLOSING THE CHEST, HE OBSERVED A SLOW OOZING OF THE BLOOD AROUND THE OUTFLOW CONNECTOR OF THE TAH-T RIGHT VENTRICLE. A HEAVY SUTURE WAS PLACED AROUND THE CONNECTOR, AND THE OOZING OF BLOOD STOPPED. THE CUSTOMER ALSO REPORTED THAT HE MAY HAVE DAMAGED THE OUTFLOW CONNECTOR BY AGGRESSIVELY STRETCHING THE CONNECTOR WITH A CLAMP PRIOR TO INSTALLATION. THERE WAS NO ADVERSE IMPACT ON THE PATIENT AS A RESULT OF THE OUTFLOW CONNECTOR LEAK OR SUBSEQUENT REPAIR. THE CUSTOMER ALSO REPORTED THAT ON (B)(6) 2014, THREE DAYS AFTER IMPLANT SURGERY, THE PATIENT EXPIRED AS THE RESULT OF A CEREBRAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327037 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 090265

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR