BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2748709 · Received September 10, 2012

    Report

    Report Number
    3003761017-2012-00051
    Event Type
    Other
    Date Received
    September 10, 2012
    Date of Event
    August 12, 2012
    Report Date
    September 7, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNCARDIA HAS INITIATED A CAPA (CORRECTIVE OR PREVENTIVE ACTION) TO ADDRESS THE CANNULA TEAR ISSUE. THE CAPA WILL DOCUMENT THE INVESTIGATION INCLUDING, BUT NOT LIMITED TO, POTENTIAL ROOT CAUSE AND CORRECTIVE ACTIONS ASSOCIATED WITH ALL CANNULA TEAR EVENTS. FROM 2004 TO 08/29/2012, THERE HAVE BEEN A TOTAL OF (B)(4) TAH-T IMPLANTS WORLDWIDE AND A TOTAL OF (B)(4) TAH-T PTS WHO EXPERIENCED A CANNULA BREACH, FOR A RATE OF ABOUT (B)(4) PERCENT ((B)(4)). NONE OF THE PTS EXPERIENCED ANY INJURIES AS A RESULT OF THE CANNULA TEARS. SYNCARDIA HAS REQUESTED THAT THE TAH-T AND CANNULA BE RETURNED TO SYNCARDIA AFTER THE PT IS TRANSPLANTED. THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T), SUPPORTED BY A CIRCULATORY SUPPORT SYSTEM (CSS) CONSOLE, ON (B)(6) 2012. HE WAS SUBSEQUENTLY SWITCHED TO A PORTABLE FREEDOM DRIVER AND WAS DISCHARGED TO HOME ON (B)(6) 2012. THE CUSTOMER REPORTED THAT ON (B)(6) 2012, 192 DAYS AFTER TAH-T IMPLANT, THE PT'S LEFT CANNULA DEVELOPED A SMALL CRACK NEAR THE DRIVELINE CONNECTOR. THE CUSTOMER ALSO REPORTED THE FREEDOM DRIVER EXHIBITED INTERMITTENT ALARMS THAT WERE POSITIONAL; THE PT'S FAMILY MEMBERS HEARD AN AIR LEAK, AND THE PT WAS RETURNED TO THE HOSPITAL AND ADMITTED FOR OBSERVATION. THE CANNULA CRACK WAS REPAIRED AT THE HOSPITAL WITH VULCANIZING TAPE, AND THE PT WAS DISCHARGED TO HOME ON (B)(6) 2012. THERE WAS NO ADVERSE IMPACT ON THE PT. THE PT IS STILL IMPLANTED WITH THE TAH-T, SUPPORTED BY A FREEDOM DRIVER, AND IS DOING WELL.

    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 074789

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention