BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 940275 · Received November 12, 2007

    Report

    Report Number
    2916596-2007-00162
    Event Type
    Death
    Date Received
    November 12, 2007
    Date of Event
    October 16, 2007
    Report Date
    October 17, 2007
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DEVELOPED PULMONARY HNT AND NEEDED AN RVAD. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED UNCONTROLLED BLEEDING AND A DECISION WAS MADE TO DISCONTINUE SUPPORT AND THE PATIENT EXPIRED. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE CHIEF OF PERFUSION THAT DURING IMPLANT, THE COVER FOR THE VENT HOLES AND THE PERCUTANEOUS LEAD BULLET TIP COVER FELL OFF WHILE TUNNELING THROUGH THE EXIT SITE. BLOOD AND TISSUE WERE INTRODUCED INTO THE DRIVELINE AND WHEN THE PUMP WAS CONNECTED TO THE CONTROLLER, THE CONTROLLER WOULD NOT ACTUATE THE PUMP AND THE PUMP DID NOT SOUND APPROPRIATE. A DECISION WAS MADE TO REMOVE THE DEVICE AND EXCHANGE IT WITH ANOTHER LVAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death