BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2550734 · Received April 18, 2012

    Report

    Report Number
    3003761017-2012-00012
    Event Type
    Other
    Date Received
    April 18, 2012
    Date of Event
    March 21, 2012
    Report Date
    April 18, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALSO REPORTED THAT BECAUSE OF ANATOMICAL REASONS, THE RIGHT AND LEFT CANNULAE WERE DIFFERENT LENGTHS AFTER THEY EXITED THE PATIENT'S BODY; THEREFORE, THERE WAS SOME ABNORMAL TWIST AND STRESS ON THE RIGHT CANNULA. AFTER THE RIGHT CANNULA WAS CUT AND REPAIRED, THE RIGHT AND LEFT CANNULAE WERE THE SAME LENGTH. SINCE THE DATE OF PMA APPROVAL TO MARCH 2012, THERE HAVE BEEN A TOTAL OF 12 PATIENTS WORLDWIDE THAT HAVE EXPERIENCED CANNULA TEARS. SYNCARDIA CONDUCTED A REVIEW OF INCOMING RECORDS FOR THE CANNULA MATERIAL. NO ADVERSE TRENDS WERE IDENTIFIED WITH RESPECT TO THE PATIENTS AFFECTED AND THE LOT OF CANNULA USED. (B)(4). NONE OF THE PATIENTS EXPERIENCED ANY INJURIES AS A RESULT OF THE CANNULA TEARS. THEREFORE, THE RISK ASSOCIATED WITH THIS ISSUE IS LOW FOR OCCURRENCE AND LOT FOR SEVERITY. THE SECTION OF DAMAGED CANNULA THAT WAS REMOVED WAS SENT TO SYNCARDIA AND WILL BE EVALUATED AS PART OF THE INVESTIGATION. SYNCARDIA HAS REQUESTED THAT THE TAH-T AND CANNULA BE RETURNED FOR INVESTIGATION AFTER THE PATIENT HAS BEEN TRANSPLANTED. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) AT (B)(6), ON (B)(6) 2012. THE CUSTOMER AT (B)(6) REPORTED THE FOLLOWING: ON (B)(6) 2012, PATIENT 2 WAS AT HOME, SUPPORTED BY A PORTABLE FREEDOM DRIVER. AFTER 61 IMPLANT DAYS, AN AIR LEAK HAD DEVELOPED IN THE PATIENT'S RIGHT TAH-T CANNULA DIRECTLY AT THE WIRE REINFORCEMENT. THE PATIENT REPORTED THAT THE LEAK WAS NOT PRESENT BEFORE, BUT IT HAPPENED "SUDDENLY" WHILE HE WAS USING THE TOILET. THE PATIENT'S WIFE REPORTED THAT THE FREEDOM DRIVER EXHIBITED AN ALARM, AND SHE PUT TAPE AROUND THE CANNULA TEAR. THE PATIENT WAS TRANSPORTED VIA AMBULANCE TO THE (B)(6) CLINIC. THE PATIENT REPORTED THAT HE FELT DIZZY FOR A SHORT MOMENT. THE RIGHT CANNULA WAS REPAIRED AT THE HOSPITAL BY CUTTING THE DRIVELINE ABOVE THE LEAK AND REINSERTING THE CPC CONNECTOR. THE DRIVELINE WAS REPAIRED WITHOUT ANY DIFFICULTIES, AND THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY.

    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 070325

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention