BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4201119 · Received October 27, 2014

    Report

    Report Number
    3007042319-2014-01131
    Event Type
    Death
    Date Received
    October 27, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT A PATIENT EXPERIENCED A HEMORRHAGIC CEREBROVASCULAR ACCIDENT. A COMPUTERIZED TOMOGRAPHY (C)T SCAN WAS PERFORMED TO DETERMINE SEVERITY OF THE BLEEDING. CARE WAS WITHDRAWN DUE TO POOR PROGNOSIS. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT REMAINS IMPLANTED. BLEEDING AND STROKE ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES TO MINIMIZE THE RISKS. ALTHOUGH A DEFINITIVE ROOT CAUSE AND RELATIONSHIP TO THE DEVICE CANNOT BE DETERMINED, CLINICAL STATUS, COMORBIDITIES, AND PHARMACOLOGICAL FACTORS ARE POSSIBLE CONTRIBUTING FACTORS. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    THE HVAD IS NOT BEING RETURNED FOR FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITH-IN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AFTER HVAD IMPLANTATION THIS PATIENT SUFFERED A HEMORRHAGIC CEREBROVASCULAR ACCIDENT (HCVA) AND EXPIRED. THE PATIENT INITIALLY PRESENTED WITH LEFT ARM WEAKNESS AND LOST CONSCIOUSNESS. INR WAS 2.7 ON THE DATE OF THE HCVA; PATIENT WAS NORMOTENSIVE WITH GOOD BLOOD PRESSURE MANAGEMENT. A COMPUTERIZED TOMOGRAPHY SCAN REVEALED INTRACEREBRAL BLEEDING, THE PATIENT WAS PRONOUNCED BRAIN DEAD AND SUPPORT WAS WITHDRAWN. THE PUMP WILL NOT BE RETURNED TO HEARTWARE FOR EVALUATION AS NO MALFUNCTION OF THE DEVICE WAS ALLEGED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682479 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death