BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6048729 · Received October 21, 2016

    Report

    Report Number
    3007042319-2016-03740
    Event Type
    Death
    Date Received
    October 21, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 29, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING HAVE BEEN UPDATED ACCORDINGLY: MODEL #/LOT #, DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. HVAD PUMP (B)(4) AND THE OUTFLOW GRAFT WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED "HIGH POWER" EVENT WAS CONFIRMED VIA LOG ANALYSIS WHICH REVEALED SEVERAL HIGH WATT ALARMS STARTING ON SEPTEMBER 28, 2016 AND AN INCREASING TREND IN POWER CONSUMPTION TO PARAMETERS OUTSIDE THE NORMAL OPERATING RANGE. THE "BEND" IN THE OUTFLOW GRAFT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED AND NO SUPPORTING EVIDENCE WAS PROVIDED BY THE SITE. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.  BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE HIGH POWER EVENT MAY BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO ANTICOAGULATION THERAPY, DISEASE PROGRESSION, AND PATIENT COMORBIDITIES. IN ADDITION, LVAD PUMP CANDIDATES OFTEN POSSESS RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED IMMOBILITY. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THERE ARE PATIENT, PHARMACOLOGICAL, AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. OUTFLOW GRAFT 378277-8604. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, WORSENING HEART FAILURE, HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. PER THE INSTRUCTIONS FOR USE (IFU): HIGH WATTS ALARMS, ARE AN INDICATION THAT THE PUMP WATTS HAS EXCEEDED THE HIGH POWER ALARM THRESHOLD, MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP, WHICH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE IFU ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAS HAD A DIFFICULT RECOVERY FROM A PREVIOUSLY REPORTED PUMP THROMBUS AND EMERGENT PUMP EXCHANGE. WHEN THE PATIENT LEFT THE OPERATING ROOM (OR), THE POWER WAS BELOW NORMAL WITH AORTIC VALVE STILL OPENING. THE PATIENT WAS STARTED ON DIALYSIS. THERE WAS A SUSPECTED BEND IN THE OUTFLOW GRAFT BUT COULD NOT CONFIRM BY COMPUTED TOMOGRAPHY (CT). THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT (ICU) WITH REPORT OF ANOTHER PUMP THROMBUS EVENT. THE POWER WAS STABLE UNTIL EVENING OF (B)(6) 2016 WITH A SLIGHT INCREASE IN POWER NOTED VIA LOG FILES, FOLLOWED BY AN ABRUPT INCREASE ON (B)(6) 2016. AGGRASTAT WAS STARTED ON (B)(6) 2016. PATIENT WAS STILL ON HEPARIN IN THE ICU WHICH WAS STARTED IN EARLY AUGUST. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED DURING THE EVENING OF (B)(6) 2016, DOSE 10 MG BOLUS FOLLOWED BY 20 MG AT 1 MG/MIN. THE POWER REDUCED BUT DID NOT REACH BASELINE AND STARTED TO INCREASE AGAIN. THE LAST REPORT RECEIVED INDICATED THAT THE PATIENT WAS GIVEN ANOTHER DOSE OF TPA ON (B)(6) 2016. THE PATIENT BECAME HYPOTENSIVE WITH MEAN ARTERIAL PRESSURE (MAP) IN THE 30S. VOLUME GIVEN BUT THERE WAS NO IMPROVEMENT. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AND EXPIRED AT MIDNIGHT ON (B)(6) 2016. AN AUTOPSY WILL NOT BE PERFORMED. THE PUMP AND PERIPHERALS WILL NOT BE RETURNED BY THE SITE. LOG FILES WERE SENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700132 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death