BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP

    MDR report key: 8883350 · Received August 12, 2019

    Report

    Report Number
    2916596-2019-03545
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 5, 2019
    Report Date
    November 27, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: ADDITIONAL INFORMATION. SECTION H3: ADDITIONAL INFORMATION. SECTION H4: ADDITIONAL INFORMATION. MANUFACTURER INVESTIGATION CONCLUSION: EVALUATION OF (B)(6) CONFIRMED THE REPORT OF PUMP THROMBOSIS. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 0.5¿ FROM THE PUMP HOUSING AND A DISTAL PORTION WAS NOT RETURNED (FIGURE 1). THE SEALED OUTFLOW GRAFT CONDUIT WAS NOT RETURNED. THE SEALED INFLOW CONDUIT WAS RETURNED DETACHED FROM THE PUMP HOUSING. THE OUTLET ELBOW WAS RETURNED ATTACHED TO ITS RESPECTIVE PUMP PORT. UPON DISASSEMBLY, VISUAL INSPECTION OF THE PUMP BLOOD-CONTACTING SURFACES REVEALED A THROMBUS IN THE PROXIMAL END OF THE OUTLET STATOR. CONTACT MARKS WERE OBSERVED ON THE OUTLET BEARING CUP, INDICATING THAT IT WAS PRESENT WHILE THE DEVICE WAS SUPPORTING THE PATIENT. THERE WAS NO EVIDENCE OF LAMINATED LAYERING TO INDICATE THAT IT INITIALLY FORMED AT THIS LOCATION, HOWEVER, ITS SPECIFIC ORIGIN COULD NOT BE DETERMINED. ALTHOUGH A SPECIFIC CAUSE FOR THE DEVELOPMENT OF THE THROMBUS AND THE DURATION OF ITS PRESENCE WITHIN THE PUMP COULD NOT BE CONCLUSIVELY DETERMINED, IT COULD HAVE CONTRIBUTED TO THE REPORT OF ELEVATED LDH. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE DID NOT REVEAL ANY ANOMALIES RELATED TO WEAR OR DAMAGE. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION 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. THE HMII IFU LISTS DEVICE THROMBOSIS AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HMII LVAS. THE IFU ADDRESSES INDICATIONS OF DEVICE THROMBOSIS AND HOW TO RESPOND TO SUCH EVENTS, AS WELL AS RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE WITH THE USE OF THE HMII LVAS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE- 2 YEARS AND 5 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT REPORTED DARK URINE AND WAS ADMITTED TO THE HOSPITAL ON (B)(6)2019 AND FOUND TO HAVE SYMPTOMS OF HEMOLYSIS. THE PATIENT WAS STARTED ON HEPARIN DROPS. RAMP STUDY WAS INCONCLUSIVE HOWEVER THE PATIENT¿S LACTATE DEHYDROGENASE (LDH) PEAKED IN 2000S U/L WITH SYMPTOMS OF THROMBOSIS. PLASMA HEMOGLOBIN 30-40, WITH DARK URINE AND HEART FAILURE. AN ECHOCARDIOGRAM AND CT PERFORMED RETURNED INCONCLUSIVE FOR THROMBOSIS; HOWEVER, DUE TO PROGRESSIVE SYMPTOMS OF LDH RISE AND HEMOLYSIS IT WAS DECIDED BY THE CLINICAL TEAM TO EXCHANGE THE PUMP. ON (B)(6) 2019, THE PATIENT UNDERWENT A PUMP EXCHANGE FROM A HEARTMATE 2 AND REPLACED WITH A HEARTMATE 3. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680278 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 104911JPN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R