BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4151690 · Received October 8, 2014

    Report

    Report Number
    3007042319-2014-01026
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 24, 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 REPORTED EVENT CODE "HIGH POWER" COULD NOT BE CONFIRMED OR REPLICATED. A REVIEW CONTROLLER LOG FILES ASSOCIATED WITH THE REPORTED EVENT DID NOT CONFIRM THE "HIGH WATT' ALARMS; HOWEVER, WAVEFORM TRENDS RELATED TO THIS EVENT ARE INDICATIVE OF AN OCCLUSION/SUCTION EVENT OR CHANGE IN PATIENT STATE SITE EVALUATION OF THE EXPLANTED PUMP AT THE END USER FACILITY REVEALING A THROMBUS FORMATION WITHIN THE PRIMARY FLOW PATH OF THE IMPELLER. IT WAS ADDITIONALLY REPORTED THAT A SMALL FIBRIN PLAQUE ON ONE OF THE SURFACES OF THE HYDRODYNAMIC BEARINGS WAS FOUND. EXTERNAL EXAMINATION OF THE PUMP AND INTERNAL COMPONENTS SHOWED NO EVIDENCE OF PHYSICAL DAMAGE OR ANOMALIES. POST-EXPLANT FUNCTIONAL ANALYSIS CONFIRMED THAT PUMP (B)(4) MET PRE-IMPLANT REQUIREMENTS WITH POWER AVERAGE CONSUMPTION OF 1.88 WATTS. A SLIGHT DEVIATION FROM THE REAR AND FROM HOUSING DISC CURVATURE WAS IDENTIFIED DURING DIMENSIONAL VERIFICATION; HOWEVER, THIS DEVIATION IS NOT EXPECTED TO IMPACT PUMP PERFORMANCE. CONSIDERING THAT PUMP PASSED THE DISC CURVATURE MEASUREMENTS PRIOR TO QA RELEASE, THIS NON-CONFORMANCE IS LIKELY A SYMPTOM OF THE CLINICAL CHALLENGE THE PUMP HAS EXPERIENCED AND IT IS GENERALLY NOT EVIDENCE OF A PUMP INDUCTED PROBLEM. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED DRIVELINE SITE INFECTION, THROMBUS FORMATION; HOWEVER, PATIENT COMORBIDITIES AND CONCOMITANT THERAPY MAY HAVE BEEN CONTRIBUTORY FACTORS. THE REPORTED "HIGH POWER" EVENT WAS NOT CONFIRMED AND THE RETURNED PUMP PASSED THE POWER CONSUMPTION REQUIREMENTS. THROMBUS IS A KNOWN RISK ASSOCIATED WITH USE OF VENTRICULAR ASSIST DEVICES NOTED WITHIN THE LABELING. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING RECOMMENDED ANTICOAGULATION MEDICATION GUIDELINES TO AVOID THROMBUS FORMATION WHILE THE HEARTWARE SYSTEM IS IMPLANTED. FURTHERMORE, HVAD PUMP CANDIDATES OFTEN POSSESS SEVERAL RISK FACTORS FOR INTRAVASCULAR COAGULATION INCLUDING ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE, AND IMMOBILITY. 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. 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 SITE HAS INDICATED THAT THE DEVICE IS NOT GOING TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND NINE MONTHS AFTER HVAD IMPLANTATION THIS PATIENT WAS HOSPITALIZED DUE TO AN ONGOING WOUND INFECTION OF THE DRIVELINE EXIT SITE. THE PATIENT FURTHER DEVELOPED HIGH WATT ALARM AND THE PUMP WAS EXPLANTED. HOSPITAL TECHNICIANS OPENED THE PUMP AND NOTED TISSUE MATERIAL ON THE IMPELLER. THE DEVICE WILL NOT BE RETURNED TO HEARTWARE FOR EVALUATION AS HOSPITAL ENGINEERS HAVE ALREADY ANALYZED AND CLEANED THE PUMP. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633580 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R