BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3760660 · Received April 7, 2014

    Report

    Report Number
    2916596-2014-00531
    Event Type
    Death
    Date Received
    April 7, 2014
    Date of Event
    January 6, 2014
    Report Date
    March 10, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS ADVISED THAT THE LVAD PUMP WAS NOT EXPLANTED FROM THE PATIENT, THEREFORE 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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE HOSPITAL THAT THE PATIENT EXPERIENCED CHRONIC RENAL FAILURE (CRF) AND THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS RIGHT HEART FAILURE, CONTRIBUTORY FACTOR - AORTIC ROOT THROMBOSIS. INFORMATION PROVIDED TO THE MANUFACTURER 7 DAYS LATER CONFIRMED PATIENT EXPIRATION DUE TO MULTISYSTEM ORGAN FAILURE. THE PATIENT HAD SEVERAL NON-VAD RELATED COMPLICATIONS AFTER IMPLANTATION, INCLUDING RESPIRATORY AND KIDNEY FAILURE. THE PATIENT'S DEATH WAS NOTED AS NOT DEVICE OR THERAPY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207068 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 128888

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death