BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4151653 · Received October 8, 2014

    Report

    Report Number
    3007042319-2014-01012
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 3, 2014
    Report Date
    September 9, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, INCLUDING TRANSPORTATION. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING STROKE, HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). WHILE THERE IS NO EVIDENCE BASED ON THE AVAILABLE INFORMATION, IT MAY BE POSSIBLE THAT THERE WERE SOME UNDERLYING HEALTH CONDITIONS THAT COULD HAVE PREDISPOSED THE PATIENT TO THIS EVENT. FROM ALL INDICATIONS THE DEVICE OPERATED WITHIN SPECIFICATIONS AND AS INTENDED WITH NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES CONTRIBUTING TO THE EVENT. AFTER HEARTWARE® SYSTEM IMPLANTATION THE PATIENT WAS NOTED TO HAVE A SUDDEN CHANGE IN MENTAL STATUS SUGGESTIVE OF A CEREBROVASCULAR ACCIDENT. VITALS AND HEARTWARE® SYSTEM PARAMETERS AT THE ONSET OF NEUROLOGICAL SYMPTOMS WERE SPEED 3040 RPM, FLOW 2.5L/MIN AND A POWER OF FOUR WATTS. VITAL SIGNS WERE HR 70 BPM, BP 119/106 MMHG WITH A MAP OF 110 MMHG. A CT SCAN OF THE HEAD ON THE MORNING OF 8/3/2014 SHOWED A NEW RIGHT TENTORIAL SUBDURAL HEMATOMA MEASURING 6MM IN THICKNESS WITH NO EVIDENCE OF ACUTE INFARCTION. REPEAT CT SCAN LATER THAT SAME DAY DEMONSTRATED A STABLE RIGHT SIDED SUBDURAL HEMATOMA. A NEUROSURGERY CONSULT ON (B)(6) 2014 RECOMMENDED EEG AND NO SURGICAL INTERVENTION. ANTICOAGULATION AT THE ONSET OF THE EVENT WAS 81MG OF ASA/DAY AND THIS WAS STOPPED. THE PATIENT WAS STARTED ON A FIVE DAY COURSE OF ORAL LEVETIRACETAM AT 500MG Q12. AN EEG PERFORMED ON (B)(6) 2014 WAS ABNORMAL AND SHOWED DIFFUSE BACKGROUND SLOWING WITH ABUNDANT TRIPHASIC WAVES, INDICATING MILD DIFFUSE CEREBRAL DYSFUNCTION. THE EEG DID NOT REVEAL ANY EPILEPTIC SEIZURE ACTIVITY. THE PATIENT IMPROVED AND ON (B)(6) 2014 DISPLAYED BETTER SPEECH PRODUCTION AND ALERTNESS WITH NO FOCAL MOTOR DEFICITS. THE 81MG OF ASA AS WELL AS ONE MG OF WARFARIN WAS RESTARTED ON (B)(6) 2014. THE NEUROLOGICAL EVENT WAS CONSIDERED RESOLVED WITH THE PATIENT'S MENTAL STATUS RETURNING TO BASELINE ON (B)(6) 2014. VITALS AND HEARTWARE® SYSTEM PARAMETERS AT RESOLUTION WERE SPEED 3040 RPM, FLOW 2.2 L/MIN AND POWER 3.8 WATTS WITH A HR OF 70 BPM AND BP OF 91/61 MMHG. DUE TO THE DEVICE NOT BEING RETURNED FOR EVALUATION AND REMAINING IMPLANTED IN THE PATIENT A MOST LIKELY ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER (B)(4), DATED (B)(6), 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HEARTWARE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE.

    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 FOUR AND HALF YEARS AFTER HEARTWARE® SYSTEM IMPLANTATION THE PATIENT WAS NOTED TO HAVE A SUDDEN CHANGE IN MENTAL STATUS SUGGESTIVE OF A CEREBROVASCULAR ACCIDENT. AN EEG WAS ABNORMAL AND INDICATED MILD DIFFUSE CEREBRAL DYSFUNCTION; ADDITIONALLY, A CT SCAN OF THE HEAD REVEALED A RIGHT-SIDED SUBDURAL HEMATOMA. ANTICOAGULATION MEDICATION WAS HELD AND THE PATIENT WAS TREATED WITH LEVETIRACETAM. THE PATIENT IMPROVED AND DISPLAYED BETTER SPEECH PRODUCTION AND ALERTNESS WITH NO FOCAL MOTOR DEFICITS. THE NEUROLOGICAL EVENT WAS CONSIDERED RESOLVED WITH THE PATIENT'S MENTAL STATUS RETURNING TO BASELINE AND ANTICOAGULATION THERAPY WAS RESTARTED. THE DEVICE WILL NOT BE RETURNED TO HEARTWARE® FOR EVALUATION AS IT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633273 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R ASPIRIN 81MG| WARFARIN