BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3870326 · Received June 12, 2014

    Report

    Report Number
    3007042319-2014-00608
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR RECURRENT VENTRICULAR TACHYCARDIA VIA A CATHETER ABLATION PROCEDURE ON AND HAD A SUBSEQUENT DECREASE IN ESTIMATED PUMP FLOW AND POWER CONSUMPTION. THE PATIENT WAS STATED TO HAVE BEEN ASYMPTOMATIC DESPITE THE DECREASE IN PUMP FLOW. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS SUB-THERAPEUTIC AT THE TIME OF THE EVENT (DUE TO THE ABLATION PROCEDURE), BUT HE WAS ADMINISTERED HEPARIN AND INOTROPES POST-ABLATION. THE PATIENT WAS IMPLANTED WITH AN INTRA-AORTIC BALLOON PUMP (IABP) TO INCREASE OVERALL CARDIAC OUTPUT. LACTATE DEHYDROGENASE (LDH) LEVELS REMAINED AT BASELINE LEVELS AND HEMATURIA WAS NOT OBSERVED. THE LEFT VENTRICLE SIZE WAS STATED TO HAVE INCREASED AND THE AORTIC VALVE WAS OPENING. THE OVERALL CARDIAC OUTPUT AND PUMP PARAMETERS HAD RETURNED TO NORMAL LEVELS AND ON LAST REPORT THE PATIENT WAS IN THE PROCESS OF BEING WEANED FROM THE IABP SUPPORT. THE PATIENT WAS LISTED FOR EMERGENT HEART TRANSPLANTATION. THE PUMP REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. REVIEW OF THE DEVICE'S MANUFACTURING RECORDS INDICATED THAT THE UNIT MET ALL THE INTERNAL REQUIREMENTS PRIOR TO THE QUALITY ASSURANCE RELEASE PROCESS. A REVIEW OF THE LOG FILES REVEALED A SUDDEN SUSTAINED DECREASE IN ESTIMATED FLOW AND POWER CONSUMPTION. WAVEFORM TRENDS OF THIS NATURE MAY BE INDICATIVE OF AN OCCLUSION OR CHANGE IN PATIENT STATE. 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, INCLUDING TRANSPORTATION. THE PUMP IS A FIXED SPEED SYSTEM. LOW FLOW, AVERAGE FLOW BELOW THE ALARM THRESHOLD, MAY BE RELATED TO POOR VAD FILLING. THE INSTRUCTIONS FOR USE ADDRESSES SETTING OF PARAMETERS FOR FLOW, POWER AND WATTS. GUIDELINES FOR POTENTIAL CAUSES OF ALARMS, ASSESSMENT OF THE PATIENT AND DEVICE STATUS ALONG WITH RELATED POTENTIAL CAUSES WHICH CAN INCLUDE RIGHT VENTRICULAR FAILURE, HYPOVOLEMIA, TAMPONADE, ARRHYTHMIAS, HIGH BLOOD PRESSURE, INFLOW CANNULA OBSTRUCTION, OUTFLOW GRAFT KINK ARE OUTLINED ALONG WITH POTENTIAL ACTIONS TO TAKE. 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 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 FIVE WEEKS AFTER HVAD IMPLANTATION, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MANAGEMENT OF RECURRENT VENTRICULAR TACHYCARDIA BY CARDIAC ABLATION. IN ANTICIPATION OF THE ABLATION PROCEDURE, ANTICOAGULATION WAS REDUCED AS NOTED BY A SUB-THERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR). FOLLOWING THE ABLATION PROCEDURE THE PATIENT DEVELOPED A SUDDEN DROP IN THE VAD POWER CONSUMPTION AND ESTIMATED FLOWS. THE PATIENT WAS STARTED ON A HEPARIN INFUSION. THE PATIENT WAS INITIALLY ASYMPTOMATIC BUT BY THE NEXT DAY, IT APPEARS THAT HIS CARDIAC OUTPUT HAD DROPPED AND HE NECESSITATED SUPPORT WITH AN INTRA-AORTIC BALLOON PUMP (IABP) AND INOTROPES. LABORATORY FINDINGS INCLUDED A NORMAL LACTATE DEHYDROGENASE (LDH) WITH NO EVIDENCE OF HEMOLYSIS AND THE PATIENT'S URINE REMAINED CLEAR. AN ECHOCARDIOGRAM REVEALED THAT THE PATIENT LEFT VENTRICLE (LV) SIZE HAD INCREASED AND HIS AORTIC VALVE WAS OPENING. THESE FINDINGS ARE REPORTED TO BE NEW FOR THIS PATIENT. THIS STUDY ALSO REVEALED NO EVIDENCE OF PERICARDIAL EFFUSION AND THE PATIENT'S RIGHT VENTRICULAR FUNCTION HAD NOT WORSENED. THE PATIENT WAS INITIALLY TREATED WITH INTRAVENOUS FLUIDS AND AN INCREASE IN THE VAD SPEED. THESE MEASURES ARE REPORTED TO HAVE IMPROVED THE VAD PARAMETERS THOUGH THEY HAD NOT NORMALIZED. FOUR DAYS AFTER THE INITIAL CHANGES IN VAD PARAMETERS, THE PATIENT'S CARDIAC OUTPUT AND VAD PARAMETERS HAD NORMALIZED. AS OF THE DATE OF THIS REPORT, THE IABP HAS BEEN DISCONTINUED AND THE PATIENT TRANSFERRED TO A REGULAR WARD IN THE HOSPITAL. THE PATIENT IS CURRENTLY LISTED UNDER STATUS 1A FOR CARDIAC TRANSPLANTATION. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347438 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R