BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2739281 · Received September 4, 2012

    Report

    Report Number
    3003761017-2012-00048
    Event Type
    Other
    Date Received
    September 4, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 30, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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 AUGUST 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. 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

    PT WAS IMPLANTED WITH A SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) AT CENTER HOSPITALIER (B)(6), ON (B)(6) 2011. HE WAS SWITCHED TO A PORTABLE SYNCARDIA FREEDOM DRIVER ON (B)(6) 2011 AND HAS BEEN LIVING AT HOME FOR THE LAST TEN MONTHS. THE PT LIVES A VERY ACTIVE LIFE AND DOES A LOT OF DRIVING, EXERCISING, ETC. ON (B)(6) 2012, SYNCARDIA WAS NOTIFIED THAT ON (B)(6) 2012, THE PT REPORTED THAT HIS LEFT CANNULA HAD DEVELOPED A CRACK IN THE EXTERNAL SHEATH. THE PT HAD BEEN IMPLANTED WITH THE TAH-T FOR 367 DAYS WHEN THE CRACK IN THE CANNULA WAS OBSERVED. THE CRACK WAS LIMITED TO THE EXTERNAL SHEATH. THE INTERNAL TUBE WAS INTACT AND THERE WAS NO LEAK OF AIR FROM THE CANNULA. THE CRACK TO THE EXTERNAL SHEATH OF THE CANNULA DID NOT AFFECT THE FUNCTIONALITY OF THE TAH-T AND HAD NO IMPACT ON THE PT. DR. (B)(6) OF (B)(6) INSPECTED THE CANNULA THE NEXT DAY WHEN HE WENT TO THE PT'S HOME TO EXCHANGE HIS FREEDOM DRIVER FOR MAINTENANCE PURPOSES. DR. (B)(6) REPORTED THAT THE CRACK WAS ALMOST CIRCULAR, BETWEEN THE DRIVELINE CONNECTOR AND THE SPRING INSURING THE REINFORCEMENT OF THE CANNULA. DR. (B)(6) REPAIRED THE CANNULA BY WRAPPING IT WITH ECC TUBING AND TAPE. THE RIGHT CANNULA WAS ALSO PROPHYLACTICALLY WRAPPED WITH ECC TUBING AND TAPE. THERE WAS NO ADVERSE IMPACT ON THE PT. THE PT IS STILL IMPLANTED WITH THE TAH-T AND IS DOING WELL. DR. (B)(6) ALSO REPORTED THAT THE CANNULA REPAIR WAS INSPECTED BY THE CLINICIANS AT CENTER HOSPITALIER (B)(6), AND THEY APPROVED OF THE REPAIR. THE REPAIR IS STABLE AND WILL BE REGULARLY INSPECTED AT PT (B)(4) FOLLOW-UP VISITS.

    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 069301

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention