BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2478074 · Received March 5, 2012

    Report

    Report Number
    2478074
    Event Type
    Death
    Date Received
    March 5, 2012
    Date of Event
    September 4, 2011
    Report Date
    August 30, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP. ADDITIONAL TEXT: ANGULATION OF INPUT CANNULA OF LEFT VENTRICULAR ASSIST DEVICE. SPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION. ADDITIONAL TEXT: INPUT LUMEN IS PARTIALLY OBSTRUCTED (60% OBSTRUCTION) BY THE INTERVENTRICULAR SEPTUM. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): NONE. OTHER INTERVENTION: IMPLANT DEVICE TYPE: LVAD. MALFUNCTION DEVICE TYPE:.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP. SPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67.3 YR Death