BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2890518 · Received December 26, 2012

    Report

    Report Number
    2916596-2012-01257
    Event Type
    Death
    Date Received
    December 26, 2012
    Date of Event
    October 5, 2012
    Report Date
    December 4, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNING TO THE MFR FOR EVAL AS AN AUTOPSY WAS NOT PERFORMED AND THE PUMP NOT EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED THE USER FACILITY REPORT ((B)(4)) FROM THE (B)(6) REGISTRY. THE REPORT INDICATED THAT THE PT EXPERIENCED RED HEART ALARMS AND NO CAUSE FOR THE ALARMS WAS IDENTIFIED DURING THE DEVICE DIAGNOSTICS TESTING AND EVAL. THE PT HAD A MCA ISCHEMIC STROKE WHICH LATER CONVERTED TO A HEMORRHAGIC STROKE. IT ALSO STATED, "THE PT'S HGBN AND LDH WERE 123, 2114 RESPECTIVELY." THE REPORT INDICATED THAT THE PT EXPIRED, AND NO OTHER DETAILS WERE PROVIDED IN THE REPORT. ADD'L INFO WAS RECEIVED FROM THE PHYSICIAN THAT THE PT'S HEMOLYSIS WAS DEVICE RELATED. THE PHYSICIAN FELT THAT THE SECONDARY CAUSE OF DEATH WAS DEVICE THROMBOSIS AND THE CAUSATIVE FACTOR WAS "PATIENT DEVICE INTRACTION". THE HOSPITAL STAFF SUSPECTS (BUT DID NOT CONFIRM) THAT THE PT HAD A THROMBUS ON THE PUMP, FLICKED SOMETHING WHICH CAUSED THE ISCHEMIC STROKE, AND THEN IT LATER CONVERTED TO HEMORRHAGIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 114084

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death