BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3946287 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-01135
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 11, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PUMP WAS RETURNED ASSEMBLED WITH THE PERCUTANEOUS LEAD (LEAD) CUT APPROXIMATELY 4 INCHES FROM THE PUMP HOUSING AND THE REMAINING PORTION OF THE LEAD WAS NOT RETURNED. ADDITIONALLY, THE END OF THE RETURNED PORTION OF THE LEAD WAS STRIPPED. THE SEALED INFLOW CONDUIT, SEALED OUTFLOW GRAFT, AND SEALED OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED, AND THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. PRIOR TO DISASSEMBLY, VISUAL INSPECTION OF THE DISTAL SIDE OF THE OUTLET STATOR REVEALED NO ADHERED DEPOSITIONS OR THROMBUS FORMATIONS; HOWEVER, THE PROXIMAL SIDE OF THE INLET STATOR DID REVEAL SOME ADHERED DEPOSITION INSIDE THE PUMP. UPON DISASSEMBLY OF THE PUMP, THE EVALUATION REVEALED A DEPOSITION WITHIN THE INLET BEARING CUP AND BALL. THE THROMBUS APPEARED TO HAVE FORMED IN LAMINATED LAYERS, WHICH IS AN INDICATION THAT IT LIKELY DEVELOPED OVER AN UNKNOWN PERIOD OF TIME WHILE THE PUMP WAS SUPPORTING THE PATIENT. ALTHOUGH A ROOT CAUSE FOR THE FORMATION OF THIS THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED, IT COULD HAVE CONTRIBUTED TO THE PATIENT¿S ELEVATED LDH. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE, AND NO ABNORMALITIES WERE OBSERVED. THE RETURNED PORTION OF THE LEAD WAS TESTED FOR CONTINUITY AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA FROM THIS TESTING REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS, AND 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2014 WITH ELEVATED LDH AND HEART FAILURE SYMPTOMS. A RAMP ECHO WAS PERFORMED AND SHOWED MILD VAD DYSFUNCTION; HOWEVER, THE PATIENT WAS STABLE. THE PATIENT WAS MOVED TO A STATUS 1A FOR A HEART TRANSPLANT. THE PATIENT WAS READMITTED ON (B)(6) 2014 WITH LDH OF 9560, AST/ALT WAS 8091/5263. THE RAMP ECHO SHOWED SEVERE VAD DYSFUNCTION. THE PATIENT'S AORTIC VALVE (AV) WAS OPENING CONSISTENTLY. THE PATIENT'S PUMP WAS EXCHANGED ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT'S IINR (INTERNATIONAL NORMALIZED RATIO) WAS MEASURED TO BE 1.6 ON (B)(6) 2014, 1.8 ON (B)(6) 2014, 2.1 ON (B)(6) 2014, 2.26 ON (B)(6) 2014, AND 3.3 ON (B)(6) 2014. A RAMP STUDY ECHOCARDIOGRAM PERFORMED ON (B)(6) 2014 REPORTEDLY ALSO SHOWED THAT THE PATIENT'S ATRIAL VALVE REMAINED CLOSED AT HIGHER RPMS, AND INDICATED THAT THE PUMP'S PEAK INLET VELOCITY WAS APPROXIMATELY 0.7 M/SEC AND THE OUTFLOW VELOCITY WAS APPROXIMATELY 1.0 M/SEC. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 FOLLOWING THE PUMP EXCHANGE ON JUNE (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393209 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 122036

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention