BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2492553 · Received March 12, 2012

    Report

    Report Number
    3003761017-2012-00008
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 9, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING IMPLANT SURGERY OF THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) AND PRIOR TO CLOSING THE CHEST, HE OBSERVED A SLOW OOZING OF BLOOD AROUND THE INFLOW CONNECTOR OF THE TAH-T LEFT VENTRICLE. A HEAVY SUTURE WAS PLACED AROUND THE CONNECTOR, AND THE OOZING OF BLOOD STOPPED. THE CUSTOMER ALSO REPORTED THAT THE MAY HAVE DAMAGED THE INFLOW CONNECTOR BY AGGRESSIVELY STRETCHING THE CONNECTOR PRIOR TO INSTALLATION. THERE WAS NO ADVERSE IMPACT ON THE PATIENT. SYNCARDIA HAS REQUESTED THAT THE LEFT VENTRICLE INFLOW CONNECTOR BE RETURNED TO SYNCARDIA FOR EVALUATION AFTER THE PATIENT HAS BEEN TRANSPLANTED. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    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 07275

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention