BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4172044 · Received October 10, 2014

    Report

    Report Number
    2916596-2014-01818
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    September 11, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION (APPROXIMATE AGE OF DEVICE, 4 MONTHS.) THE REPORT OF HEMOLYSIS WAS CONFIRMED BASED ON THE EVALUATION OF THE LVAD. A THROMBUS FORMATION WAS FOUND ADHERED AROUND THE INLET BEARING CUP AND BALL. THE THROMBUS RING REVEALED AREAS OF DENATURATION AND ALSO APPEARED TO FORM IN LAMINATED LAYERS, INDICATING THAT IT DEVELOPED ON THE INLET BEARING CUP AND BALL OVER AN UNDETERMINED AMOUNT OF TIME WHILE THE PUMP WAS SUPPORTING THE PATIENT. IN ADDITION, A TISSUE-LIKE DEPOSITION WAS ALSO FOUND IN THE OUTLET STATOR ADJACENT TO THE BEARING BALL. THE DEPOSITION DID NOT SHOW ANY EVIDENCE OF LAMINATED LAYERING, SUGGESTING THAT IT DID NOT INITIALLY FORM IN THE OUTLET STATOR. ALTHOUGH ITS ORIGIN AND A DURATION OF TIME FOR WHICH IT WAS PRESENT IN THE PUMP COULD NOT BE CONCLUSIVELY DETERMINED, THE AREA OF DENATURATION ADJACENT TO THE BEARING BALL AS WELL AS THE CONTACT MARKS PRESENT ON THE OUTLET PORTION OF THE ROTOR INDICATE THAT THE DEPOSITION WAS PRESENT DURING SUPPORT. THE OBSERVED DEPOSITIONS WERE PARTIALLY OBSTRUCTING THE BLOOD FLOW PATH AND COULD HAVE CONTRIBUTED TO THE REPORTED HEMOLYSIS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD CONTACTING SURFACES DID NOT REVEAL ANY ANOMALIES. ELECTRICAL CONTINUITY TESTING OF BOTH THE PUMP END AND DISTAL END OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. FUNCTIONAL TESTING OF THE PUMP UNDER NORMAL OPERATING CONDITIONS REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES COMPARABLE TO THE DATA RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. 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. IT WAS REPORTED THAT THE SYMPTOMATIC PATIENT WAS ADMITTED WITH SIGNS OF FATIGUE, SHORTNESS OF BREATH, JAUNDICE, DARKENED URINE AND CHEST PRESSURE. THE PATIENT WAS FOUND TO HAVE A PEAK LACTATE DEHYDROGENASE LEVEL OF 6130, HEMATOCRIT LEVEL OF 11.8, PLASMA FREE HEMOGLOBIN LEVEL OF 21.5, URINALYSIS WITH 3+BLOOD AND ELEVATED LIVER FUNCTION TESTS. THE PATIENT WAS TREATED WITH BIVALIRUDIN AND AN ECHOCARDIOGRAM THAT WAS PERFORMED REVEALED NO OBVIOUS CLOT AND THE LEFT VENTRICLE DID DECOMPRESS. THE PATIENT'S LACTATE DEHYDROGENASE LEVEL NORMALIZED AND SYMPTOMS IMPROVED WITH TREATMENT. THE PATIENT WAS FOUND TO HAVE A "GOOD" LEFT VENTRICLE RECOVERY AND A DECISION WAS MADE TO EXPLANT INSTEAD OF REPLACING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643113 HEARTMATE II LVAS DSQ THORATEC CORP. 106015 136667

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention