BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3925367 · Received July 10, 2014

    Report

    Report Number
    3007042319-2014-00698
    Event Type
    Death
    Date Received
    July 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 11, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT HAD A DRIVELINE INFECTION AND STARTED HAVING LOW FLOWS. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED AN OBSTRUCTIVE THROMBUS IN THE LVAD OUTFLOW GRAFT AND TWO STENTS PLACED IN THE OUTFLOW GRAFT, RETURNING PUMP FLOWS TO BASELINE VALUES. HOWEVER, THE PATIENT'S CONDITION CONTINUED TO DETERIORATE AND THE PATIENT EXPIRED. THE PUMP AND OUTFLOW GRAFT WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE PUMP ((B)(4)) AND OUTFLOW GRAFT (485827) MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT COULD NOT BE CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES SINCE LOG FILES COVERING THE EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. POST EXPLANT FUNCTIONAL ANALYSIS CONFIRMED THAT PUMP ((B)(4)) MET PRE-IMPLANT REQUIREMENTS WITH AVERAGE POWER CONSUMPTION OF 1.98 WATTS. DHR REVIEW, VISUAL EXAMINATION AND DIMENSIONAL VERIFICATION DID NOT IDENTIFY MANUFACTURING OR DESIGN DISCREPANCIES THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. INDEPENDENT PATHOLOGICAL REPORT REVEALED NO GROSS EVIDENCE OF DEVICE COMPLICATION OR THROMBUS FORMATION. HOWEVER, THE SITE NOTED THROMBUS IN THE OUTFLOW GRAFT AS MENTIONED IN THE NARRATIVE. BASED ON THE INVESTIGATION, THE RETURNED PUMP PERFORMED PER SPECIFICATIONS AND THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE MALFUNCTIONED. A POSSIBLE ROOT CAUSE FOR THE REPORTED EVENT MAY BE ATTRIBUTED TO AN EXTRINSIC FORCE COMPRESSING/POSSIBLY KINKING THE OUTFLOW GRAFT. 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 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT IS IN ROUTE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT APPROXIMATELY TWO YEARS AND THREE MONTHS POST IMPLANTATION THE PATIENT EXPIRED DUE TO VASODILATORY SHOCK AND CARDIOPULMONARY FAILURE RESULTING FROM LEFT VENTRICULAR ASSIST DEVICE OUTFLOW TRACK THROMBOSIS. THE PATIENT WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL WHERE HE PRESENTED WITH PERSISTENT BLEED OF LEFT LOWER EXTREMITY VARICOSE VEIN AND QUESTIONABLE GI BLEED. DUE TO HISTORY OF MULTIPLE GI BLEEDS HE WAS NOT ON ANTICOAGULANTS OR ANTIPLATELETS. ON ADMISSION THE PATIENT WAS ALSO FOUND TO BE VOLUME OVERLOADED WITH ELEVATED CREATININE AND THE DRIVELINE EXIT SITE WAS INFECTED. NUMEROUS SPECIALISTS WERE CONSULTED INCLUDED VASCULAR SURGERY, INFECTIOUS DISEASE AND NEPHROLOGY. THE PATIENT WAS TREATED WITH TRANSFUSIONS AND SURGICAL STITCH FOR THE BLEEDING, INTRAVENOUS ANTIBIOTICS FOR THE INFECTION, DIURETICS AND EVENTUALLY VENO-VENOUS HEMOFILTRATION WHEN RENAL FAILURE PROGRESSED TO OLIGURIA. SIX DAYS INTO THE ADMISSION, THE PATIENT EXPERIENCED LOW FLOW ALARMS AND HYPOTENSION AND WAS ADMINISTERED IV FLUIDS. HOWEVER, LOW FLOWS CONTINUED AND PATIENT WAS PLACED ON HEPARIN, MILRINONE AND EVENTUALLY VASOPRESSIN AS ECHOCARDIOGRAM SUGGESTED POSSIBLE PUMP THROMBOSIS WHICH WAS LATER CONFIRMED ON CT SCAN. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE TWO STENTS WERE PLACED IN THE OUTFLOW CANNULA WITH IMPROVEMENT IN VAD FLOW. THE PATIENT'S CONDITION CONTINUED TO DETERIORATE DUE TO IRREVERSIBLE END ORGAN DAMAGE AND HE WAS TRANSITIONED TO COMFORT CARE MEASURES ONLY AND EXPIRED. AN AUTOPSY WAS PERFORMED AND REPORTED "GRAFT STENTS (2) GROSSLY IDENTIFIED AND PATENT IN PUMP DEVICE." PER NOTES IN DATABASE "THERE IS NO MENTION OF INTRA-CANNULA THROMBUS OR EXTRINSIC COMPRESSION OF CANNULA." THE SITE OPTED TO RETAIN THE PUMP BUT THE OUTFLOW GRAFT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THIS EVENT IS BELIEVED TO BE RELATED TO THE DEVICE AND PATIENT CONDITION BY THE TREATING PHYSICIAN. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND THREE MONTHS POST HVAD IMPLANTATION, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CONFIRMED OUTFLOW GRAFT THROMBUS. HE WAS TAKEN FOR CARDIAC CATHETERIZATION WHERE A STENT WAS SUCCESSFULLY PLACED. POST-PROCEDURE, THE PATIENT DEVELOPED MULTI-ORGAN SYSTEM FAILURE AND EXPIRED. THE PUMP WAS EXPLANTED, BUT WAS RETAINED BY THE SITE. THE OUTFLOW GRAFT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403722 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death COUMADIN| SPIRONOLACTONE| TORSEMIDE