BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4100890 · Received September 12, 2014

    Report

    Report Number
    2916596-2014-01599
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THROMBUS WAS CONFIRMED THROUGH THE EVALUATION OF THE RETURNED LVAD PUMP. THE DEVICE WAS RETURNED ASSEMBLED WITH THE PERCUTANEOUS LEAD (LEAD) CUT APPROXIMATELY 12¿ FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE LEAD WAS NOT RETURNED. THE INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RETURNED DETACHED FROM THE PUMP¿S INLET PORT. THE OUTFLOW GRAFT AND THE OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED. THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. ANALYSIS OF THE INFLOW CONDUIT AND THE OUTFLOW ELBOW REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. EXAMINATION OF THE PUMP UPON DISASSEMBLY REVEALED A THROMBUS FORMATION SURROUNDING THE BEARING BALL WITHIN THE PROXIMAL SIDE OF THE OUTLET STATOR. THIS CLOT¿S LACK OF LAMINATED LAYERING INDICATES THAT IT DID NOT INITIALLY FORM IN THE OUTLET STATOR. WHILE THE ORIGIN OF THIS DEPOSITION COULD NOT CONCLUSIVELY BE DETERMINED, ITS AREAS OF DENATURATION ADJACENT TO THE BEARING BALL, AS WELL AS THE SLIGHT CONTACT MARKS AT THE DISTAL END OF THE ROTOR, SUGGEST THAT IT WAS PRESENT WHILE (B)(4) WAS SUPPORTING THE PATIENT. ALTHOUGH A CAUSE FOR THE FORMATION OF THIS CLOT COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION, IT COULD HAVE CONTRIBUTED TO THE PATIENT¿S ELEVATED LACTATE DEHYDROGENASE. UPON REMOVAL OF THE OBSERVED DEPOSITION, THE DEVICE WAS CLEANED. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE THEN EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. ELECTRICAL CONTINUITY TESTING OF THE PERCUTANEOUS LEAD DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS AND THE DEVICE FUNCTIONED AS INTENDED. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).THE PATIENT'S EXPIRATION WAS REPORTED UNDER MEDWATCH MFR REPORT # 2916596-2015-00203. THIS REPORT IS REGARDING THE PATIENT'S PUMP EXCHANGE.

    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.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS EXPERIENCING ELEVATED LACTATE DEHYDROGENASE (LDH). IT WAS NOTED THAT THE PATIENT HAD MISSED SEVERAL DOSES OF COUMADIN. DEVICE THROMBUS WAS SUSPECTED. THE FOLLOWING DAY, THE PUMP WAS EXCHANGED FROM ONE LVAD TO ANOTHER LVAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(6) REGISTRY STATING: PATIENT WAS NOTED WITH ELEVATED LDH, PLASMA FREE HGB AND BLOOD IN URINE NOT IMPROVING WITH HEPARIN DRIP AND INCREASE INR GOAL. ECHO RAMP STUDY INDICATED POOR LV UNLOADING ADDITIONAL INFORMATION ALSO INCLUDED INDICATED: HEMOLYSIS: YES. ABNORMAL PUMP PARAMETERS: YES. THROMBUS EVENT CONFIRMED: Y. DEVICE MALFUNCTION: N. DEVICE MALFUNCTION CAUSATIVE FACTOR: PATIENT NON-COMPLIANCE, SUB THERAPEUTIC ANTICOAGULATION. ADDITIONAL INFORMATION ALSO INDICATED THAT THE PATIENT EXPIRED ON (B)(6) 2014. PRIMARY CAUSE OF DEATH: SUBDURAL HEMORRHAGE. DEVICE FUNCTION NORMAL: Y.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566220 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 98720

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention