BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC

    MDR report key: 5027072 · Received August 21, 2015

    Report

    Report Number
    5027072
    Event Type
    Death
    Date Received
    August 21, 2015
    Date of Event
    July 8, 2019
    Report Date
    August 11, 2015
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL WITH COMPLAINT OF CHEST PAIN. ON ARRIVAL IN EMERGENCY DEPARTMENT, THE LVAD WAS INTERROGATED, WHICH SHOWED MULTIPLE LOW FLOW ADVISORIES AND PUMP STOPPAGES. THE PATIENT WAS ADMITTED TO UNDERGO FURTHER EVALUATION. DURING ADMISSION, CHEST AND ABDOMINAL X-RAYS WERE OBTAINED AND SENT TO MANUFACTURER ALONG WITH LOG FILES FROM LVAD. MANUFACTURER ENGINEERS WERE PRESENT AND REPLACED 19 INCHES OF EXTERNAL PERCUTANEOUS LEAD. CT SCAN OF CHEST AND ABDOMEN RESULTS REVEALED A TYPE A AORTIC DISSECTION NOT PREVIOUSLY NOTED AND AN EXISTING ABDOMINAL AORTIC ANEURYSM. PT WAS EVALUATED BY CARDIOTHORACIC SURGEON FOR POSSIBILITY OF LVAD EXCHANGE AND/OR AORTIC DISSECTION REPAIR. IT WAS DETERMINED THE PATIENT'S CHANCE OF SURVIVAL FOR SURGICAL INTERVENTION WAS POOR. THIS WAS DISCUSSED WITH PATIENT AND PATIENT DID NOT WISH TO UNDERGO SURGERY AND WAS DISCHARGED HOME WITH HOSPICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554503 THORATEC HOARTMATC II DSQ THORATEC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| R