BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3760784 · Received April 7, 2014

    Report

    Report Number
    2916596-2014-00437
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP AS WELL AS THE OUTFLOW GRAFT AND OUTFLOW GRAFT BEND RELIEF FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 3.5 YEARS POST-IMPLANT, IT WAS REPORTED THAT THE PT WAS ADMITTED WITH SIGNS OF HEMOLYSIS AND HAEMATURIA. THE PT'S LACTATE DEHYDROGENASE (LDH) AND PLASMA FREE HEMOGLOBIN WAS ELEVATED. THE HOSPITAL DECIDED TO EXCHANGE THE PUMP AND DURING THE EXCHANGE IT WAS REPORTED THAT THE OUTFLOW GRAFT BEND RELIEF WAS DISCONNECTED. THE PUMP AND THE OUTFLOW GRAFT BEND RELIEF WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205701 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103693 92620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention