BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2496613 · Received March 16, 2012

    Report

    Report Number
    2916596-2012-00230
    Event Type
    Death
    Date Received
    March 16, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 18, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION 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 THE PATIENT WAS INITIALLY PRESENTED WITH CHEST PAIN, DEVELOPED BROWN/BLACK URINE AND HEMOLYSIS. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR AORTIC VALVE REPAIR DUE TO AI AND ARCH DISSECTION AND REPAIR. THE PATIENT ALSO HAD SUSPECTED THROMBUS. THE LVAD WAS EXCHANGED WITH ANOTHER LVAD, HOWEVER, THE PATIENT COULD NOT COME OFF BYPASS AND EXPIRED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 95472

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death