BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5500509 · Received March 15, 2016

    Report

    Report Number
    3007042319-2016-01123
    Event Type
    Death
    Date Received
    March 15, 2016
    Date of Event
    September 17, 2015
    Report Date
    January 19, 2016
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HVAD PUMP (B)(4), BATTERIES (B)(4) AND CAC ADAPTER (B)(4) WERE RETURNED TO HEARTWARE FOR EVALUATION. CONTROLLER (B)(4), BATTERY (B)(4) AND CAC ADAPTER (B)(4) WERE NOT RETURNED FOR EVALUATION. THIS COMPLAINT IS ASSOCIATED WITH A CLINICAL ADVERSE EVENT. VARIOUS ANALYSES OF THE RETURNED DEVICES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION OF (B)(4) CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL THE REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES WAS NOT POSSIBLE SINCE LOG FILES WERE NOT AVAILABLE FOR ANALYSIS. ANALYSIS OF (B)(4) REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION, DIMENSIONAL VERIFICATION AND FUNCTIONAL TESTING. INDEPENDENT PATHOLOGY REPORT DID NOT REVEAL EVIDENCE OF THROMBUS WITHIN THE PUMP. BATTERIES (B)(4) AND CAC ADAPTER (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. DEATH AS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. FURTHERMORE, THESE BENEFITS APPLY TO PATIENTS BEING BRIDGED TO HEART TRANSPLANT, PATIENTS RECEIVING PERMANENT SUPPORT (DESTINATION THERAPY), AND THOSE BEING SUPPORTED WITH THE EXPECTATION FOR MYOCARDIAL RECOVERY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ARCHIVIST THAT THE PATIENT EXPIRED. THE HEART AND VAD WERE SENT TO CVPATH FOR AUTOPSY REPORT. INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158941 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)-BATTERY