BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1150419 · Received September 5, 2008

    Report

    Report Number
    2916596-2008-00122
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 10, 2008
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD AND THE PATIENT REMAINS ONGOING WITHOUT ANY FURTHER ISSUES. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, AND THE REPORTED EVENT WAS CONFIRMED AND ATTRIBUTED TO THE INNER CAM FOLLOWER BEARING. THE INNER CAM FOLLOWER BEARING SOCKET RETAINERS SHOWED SIGNS OF WEAR AND ONE OF THE RETAINERS WAS SPLIT IN HALF. THE RESULT OF THE INNER CAM FOLLOWER BEARING COMPROMISE APPEARED TO CONTRIBUTE TO SIGNIFICANT DRAG OF THE INNER CAM FOLLOWER BEARING ON THE INNER CAM SURFACE AND HIGH PUMP POWER CONSUMPTION, WHICH ULTIMATELY LED TO THE REPORTED EVENT. ALTHOUGH, CONTRIBUTING FACTORS SUCH AS HIGH AFTER LOAD AND HIGH BEAT RATES FOR EXTENDED PERIODS CAN CONTRIBUTE TO LUBRICANT LOSS AND BREAKDOWN THUS REDUCING THE MECHANICAL LIFE EXPECTANCY OF THE DEVICE, A DIRECT RELATIONSHIP BETWEEN THESE POTENTIAL FACTORS AND THE INNER CAM FOLLOWER BEARING WEAR IS INCONCLUSIVE AT THIS TIME. BEARING WEAR ISSUES ARE CURRENTLY BEING ADDRESSED THROUGH THE MANUFACTURER'S DESIGN CHANGE SYSTEM. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE PERFUSIONIST THAT THE PATIENT PRESENTED AT THE HOSPITAL WITH YELLOW WRENCH AND RED HEART ADVISORY ALARMS ON THE SYSTEM CONTROLLER. IT WAS ALSO REPORTED THAT THE DEVICE STOPPED WHILE THE PATIENT WAS BEING TRANSPORTED TO THE HOSPITAL BY AMBULANCE AND THAT THE PATIENT HAD INITIATED HAND PUMPING. ONCE AT THE HOSPITAL, THE PATIENT WAS PLACED ON PNEUMATIC SUPPORT USING AN IP CONSOLE AND STROKE VOLUME LIMITER (SVL). THE SYSTEM CONTROLLER WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE REPORTED ALARMS. A DECISION WAS MADE BY THE HOSPITAL TO REPLACE THE LVAD WITH ANOTHER LVAD SINCE ATTEMPTS TO PLACE THE PATIENT BACK ON ELECTRICAL ACTUATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 1270 46234

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention