BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 2894173 · Received December 27, 2012

    Report

    Report Number
    2916596-2012-01269
    Event Type
    Death
    Date Received
    December 27, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 4, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS ADVISED THAT THE BIVAD PUMPS, SERIAL NUMBER (B)(4) AND SERIAL NUMBER (B)(4) WILL NOT BE RETURNING FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. THE ATTACHED USER FACILITY REPORT WAS RECEIVED FROM THE INTERMACS REGISTRY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH BIVENTRICULAR SUPPORT. THE MANUFACTURER RECEIVED A USER FACILITY REPORT RECEIVED FROM THE INTERMACS REGISTRY WHICH STATED: THE PT WAS "FOUND TO HAVE FUNCTIONAL INFLOW OBSTRUCTION AND BIVAD FAILURE." THE PT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 14086-2550-000 87592

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death