BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5686888 · Received May 27, 2016

    Report

    Report Number
    2916596-2016-01012
    Event Type
    Death
    Date Received
    May 27, 2016
    Date of Event
    April 30, 2016
    Report Date
    May 3, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE - 1 YEAR. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER''S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. UPON DISASSEMBLY, EXAMINATION OF THE LUMEN OF THE OUTFLOW ELBOW REVEALED NON-LAMINATED DEPOSITIONS SITUATED ON THE TEXTURED BLOOD-CONTACTING SURFACE. SIMILAR DEPOSITIONS WERE SITUATED IN THE LUMEN OF THE INLET ELBOW. ALTHOUGH SPECIFIC CAUSES FOR THEIR DEVELOPMENT COULD NOT BE CONCLUSIVELY DETERMINED, THE DEPOSITIONS APPEARED TO HAVE DEVELOPED IN THESE AREAS. THE DEPOSITIONS; HOWEVER, DID NOT APPEAR TO OCCLUDE THE FLOW OF BLOOD THROUGH THE PUMP AND WOULD NOT HAVE CONTRIBUTED TO ANY FUNCTIONAL ISSUES. EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES REVEALED NO DEPOSITIONS. A CORRELATION BETWEEN THE DEPOSITIONS FOUND IN THE EVALUATION AND THE REPORT OF SEPSIS, OR THE REPORT OF HEMORRHAGIC STROKE COULD NOT BE DETERMINED. EXAMINATION OF THE PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE, REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE DEPOSITIONS. THE PUMP UNDERWENT CLEANING, REASSEMBLY AND FUNCTIONAL TESTING UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS AND THE PUMP OPERATED AS INTENDED. NO DEVICE-RELATED ISSUES WERE FOUND DURING THE EVALUATION. THE INSTRUCTIONS FOR USE LISTS INFECTION, SEPSIS, BLEEDING, AND STROKE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT HAD A SEIZURE AT HOME AND WAS TAKEN TO THE ER. THE PATIENT WAS LETHARGIC BUT WAS ABLE TO FOLLOW COMMANDS AND ANSWER QUESTIONS. THE PATIENTS¿ BLOOD SUGAR UPON ER ADMISSION WAS 70 MG/DL AND POTASSIUM LEVEL WAS 2.7 MEQ/L. A CT OF THE HEAD SHOWED NO ACUTE CHANGES. IT WAS REPORTED THAT THE PATIENT HAD A KNOWN HISTORY OF SEIZURE DISORDER. THE PATIENT WAS ADMITTED TO THE CARDIAC ICU FOR FURTHER EVALUATION. IT WAS REPORTED THAT NO ALARMS WERE OBSERVED THROUGHOUT THE SERIES OF EVENTS. THE PATIENT¿S WHITE BLOOD CELL COUNT WAS NOTED TO BE ELEVATED AT 25 X 10^9/L, SO A URINALYSIS AND BLOOD CULTURES WERE OBTAINED. URINALYSIS SHOWED 3+ BACTERIA AND PROCALCITONIN CAME BACK AT 13.09 MICROGRAMS/L SO SEPSIS PROTOCOL WAS FOLLOWED. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS (ZOSYN AND VANCOMYCIN) AS WELL AS FLUID REPLACEMENT (NORMAL SALINE AT 125 CC/HOUR). IT WAS REPORTED THAT THE PATIENT¿S INR HAD BEEN LOW THE LAST FEW DAYS (1.5 ON (B)(6) 2016) AND UPON ADMISSION IT WAS 1.8. LOVENOX 100MG SUBCUTANEOUS WAS STARTED TO BRIDGE THE PATIENT TO A THERAPEUTIC INR. THE FOLLOWING DAY THE PATIENT APPEARED TO BE RESPONDING TO TREATMENTS. ALL ELECTROLYTES WERE BACK WITHIN NORMAL RANGES AND THE PATIENT PRESENTED AGAIN AS NORMAL SELF. AT ROUGHLY 12:20 THE PATIENT TOLD THE NURSE THAT THEY HAD A HEADACHE AND ¿JUST FELT KIND OF FUNNY¿. THE NURSE LEFT TO SEEK ADVICE FROM ONE OF THE VAD COORDINATORS AND UPON THEIR RETURN WITHIN FIVE MINUTES, THE PATIENT HAD GONE UNRESPONSIVE AND WAS HAVING ANOTHER SEIZURE V. RAPID POSTURING. A HEAD CT SHOWED A LARGE LEFT HEMISPHERE SUBDURAL HEMATOMA WITH A SEVERE LEFT TO RIGHT MIDLINE SHIFT. THE PATIENT¿S INR AT THIS TIME WAS 1.9, AND THE INR WAS REVERSED IN PREPARATION FOR SURGERY. THE PATIENT WAS TRANSFERRED TO BRYAN HEALTH WEST CAMPUS FOR AN EMERGENT CRANIOTOMY. THE PATIENT REPORTEDLY REMAINED UNSTABLE THROUGHOUT THE NIGHT POST-SURGERY, AND DURING A REPEAT HEAD CT THE MORNING OF (B)(6) 2016 PERFUSE BLEEDING WAS STILL OBSERVED WITH BLOOD IN ALL FOUR VENTRICLES. THE PATIENT WAS PRONOUNCED BRAIN DEAD ON THE AFTERNOON OF (B)(6) 2016 AFTER A FAILED APNEA TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339581 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death