BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3854198 · Received June 6, 2014

    Report

    Report Number
    3007042319-2014-00573
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 14, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT HAD ELEVATED FLOW ESTIMATIONS ON HIS RIGHT VENTRICULAR ASSIST DEVICE (RVAD). THE RVAD PUMP ((B)(4)) WAS EXCHANGED AND DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. MECHANICAL MEASUREMENTS OF VARIOUS PUMP REQUIREMENTS WERE PERFORMED. THE PRESENCE OF FRICTION MARKS INDICATE THAT SOMETHING FORCED THE IMPELLER AGAINST THE REAR HOUSING WITH SUFFICIENT FORCE TO OVERCOME THE REAR PRELOAD OF THE MAGNETIC SPRING/SUSPENSION SYSTEM. AS SUCH, THE PRESENCE OF FRICTION MARKS IS THE SYMPTOM OF THE CLINICAL CHALLENGE THE PUMP HAS EXPERIENCED AND IS NOT EVIDENCE OF A PUMP RELATED PROBLEM. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA CONTROLLER LOG FILES WHICH SHOWED TRENDS INDICATIVE OF THROMBUS; PATHOLOGICAL EXAMINATION CONFIRMED THE PRESENCE OF THROMBUS WITHIN THE PUMP WHICH WOULD INCREASE THE POWER REQUIREMENTS RESULTING IN THE HIGH WATT ALARMS. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED HIGH POWER EVENT MAY BE ATTRIBUTED TO THROMBUS FORMATION WITHIN THE DEVICE. 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 DEVICE THROMBOSIS, HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES OF INR BETWEEN 2.0 AND 3.0). 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. 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 DEVICE HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    APPROXIMATELY FOUR MONTHS AFTER THE HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT HAD HAD ELEVATED FLOW ESTIMATIONS ON HIS RIGHT-SIDED VAD. THE PATIENT'S MEDICATIONS AT THE TIME OF THE EVENT INCLUDED COUMADIN AND ASPIRIN (325MG). OF NOTE, THE SITE REPORTED THAT COMPLIANCE WITH MEDICAL THERAPY HAD BEEN AN ISSUE WITH THIS PATIENT. THE PATIENT WAS ADMITTED TO A LOCAL FACILITY WHERE A HEPARIN INFUSION WAS STARTED AND THEN TRANSFERRED TO THE VAD-IMPLANTING FACILITY. THE SITE REPORTED THAT THE PATIENT WAS STABLE AT THIS POINT WITH MINIMAL HEART FAILURE. THE PATIENT'S HEPARIN INFUSION WAS CONTINUED WITH A THERAPEUTIC PARTIAL THROMBOPLASTIN (PTT) GOAL OF 60-80 SECONDS, HIS COUMADIN HELD, HIS ASPIRIN CONTINUED AND HE WAS STARTED ON AN INTEGRILIN INFUSION. HE WAS ALSO TREATED WITH TWO UNITS OF PACKED CELLS. THIS WAS FOLLOWED BY A 30 MINUTE BOLUS OF TPA (INTEGRILIN HELD DURING THIS TIME) WITH CONTINUED HEPARIN. THOUGH THE PATIENT'S VAD PARAMETERS DID INITIALLY DECREASE, THEY STARTED TO RISE AGAIN. THE PATIENT WAS GIVEN ANOTHER DOSE OF TPA THE NEXT DAY WITH LITTLE CHANGE IN THE VAD PARAMETERS AND HIS INTEGRILIN WAS RE-STARTED THE FOLLOWING DAY. A FEW DAYS LATER, THE PATIENT'S URINE IS REPORTED TO HAVE TURNED A "MOTOR OIL" COLOR WITH CONTINUED ELEVATED VAD POWER CONSUMPTION. THE RVAD PUMP WAS EXCHANGED ONE MONTH AFTER EVENT ONSET. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331193 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R ASPIRIN (325MG)