BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3821576 · Received May 20, 2014

    Report

    Report Number
    3007042319-2014-00416
    Event Type
    Death
    Date Received
    May 20, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 23, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT (POST MORTEM) AND IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT (B)(4) MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES REVEALED POWER CONSUMPTION WITHIN THE NORMAL OPERATING RANGE, ALONG WITH A DROP IN FLOWS AND MULTIPLE "LOW FLOW" ALARMS THAT CORRELATE TO THE REPORTED EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    APPROXIMATELY THREE MONTHS AFTER THE IMPLANTATION, THE PATIENT'S CONDITION NECESSITATED CARDIOPULMONARY RESUSCITATION (CPR) WITH LOW VAD FLOW ESTIMATIONS. DETAILS REGARDING ANY RECENT COMPLICATIONS, CONTRIBUTORY FACTORS THAT MAY HAVE PRECIPITATED THIS EVENT OR PATIENT SYMPTOMS WERE NOT PROVIDED. DETAILS REGARDING THE RESULTS OF ANY DIAGNOSTIC TESTING WERE NOT PROVIDED. DESPITE THESE EFFORTS, THE PATIENT IS REPORTED TO HAVE EXPIRED. DETAILS REGARDING THE CAUSE OF DEATH, WHETHER AN AUTOPSY WAS PERFORMED OR ITS' RESULTS WERE NOT PROVIDED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE HEARTWARE DEVICE BY THE PATIENT'S TREATING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300378 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| L| R ASPIRIN| MARCOUMAR