BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3950814 · Received June 13, 2014

    Report

    Report Number
    2916596-2014-00970
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT DURING THE PATIENT'S HEART TRANSPLANT IT WAS FOUND THAT THE OUTFLOW GRAFT HAD SEPARATED AT THE BEND RELIEF. FIBRINOUS MATTER WAS WITHIN THE CANNULA. THE FIBRIN WAS SLICED AND WAS SENT FOR CULTURE. THE PATIENT WAS SUCCESSFULLY TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350483 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 101800

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other