BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4151536 · Received October 8, 2014

    Report

    Report Number
    3007042319-2014-01021
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 11, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED A PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF RIGHT HEART FAILURE. THEY WERE PLACED ON AN INOTROPE AND DIALYSIS FOR FLUID MANAGEMENT. DURING THIS TIME THE PATIENT SUFFERED A DROP IN HEMOGLOBIN AND REQUIRED A BLOOD TRANSFUSION. ONE EPISODE OF MELENIC STOOL WAS REPORTED AND THE PATIENT UNDERWENT A GASTROINTESTINAL (GI) ENDOSCOPY FOR EVALUATION. IT WAS REPORTED THE PATIENT'S NEUROLOGICAL STATUS DETERIORATED AND REQUIRING INTUBATION. A HEAD COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A CEREBRAL INFARCT, THOUGHT TO BE EMBOLIC. THE PATIENT EXPIRED IN THE HOSPITAL AS CARE WAS WITHDRAWN. AN AUTOPSY WAS NOT PREFORMED. THE DEVICE REMAINED IMPLANTED POST-MORTEM AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEATH, RIGHT HEART FAILURE, RESPIRATORY FAILURE GI BLEEDING, RENAL FAILURE, AND STROKE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION OR PERFORMANCE ISSUES IMPACTING THE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, CLINICAL, PHARMACOLOGICAL, AND PATIENT FACTORS INCLUDING COMORBIDITIES ARE KNOWN POSSIBLE CONTRIBUTORS TO THESE TYPE OF EVENTS. 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 (B)(4), DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY THREE MONTHS AFTER HVAD IMPLANTATION, THIS PATIENT SUFFERED A STROKE AND EXPIRED. THE PATIENT WAS INITIALLY ADMITTED TO THE HOSPITAL FOR RIGHT HEART FAILURE THAT REQUIRED DIALYSIS FOR FLUID MANAGEMENT. DURING ADMISSION, THE PATIENT EXPERIENCED A DROP IN HEMOGLOBIN THAT REQUIRED BLOOD TRANSFUSION, DETERIORATION IN NEUROLOGICAL STATUS, MELENA FOLLOWING ENDOSCOPY, AND WAS INTUBATED. A COMPUTERIZED TOMOGRAPHY SCAN REVEALED AN INFARCT WHICH WAS CONSIDERED TO BE EMBOLIC. THE PATIENT FURTHER DEVELOPED FIXED DILATED PUPILS AND THE MEDICAL TEAM SUSPECTED A BRAIN STEM INFARCT. TREATMENT WAS WITHDRAWN AND THE PATIENT SUBSEQUENTLY EXPIRED. THE DOCTOR DOES NOT BELIEVE THIS PATIENT'S DEATH WAS DEVICE RELATED BUT RATHER THE RESULT OF AN EMBOLIC STROKE. THE DEVICE WILL NOT BE RETURNED TO HEARTWARE FOR EVALUATION AS IT REMAINS IMPLANTED POST MORTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633468 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death WARFARIN