BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3780722 · Received April 22, 2014

    Report

    Report Number
    2916596-2014-00583
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 25, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED WITH THE DRIVELINE CUT APPROXIMATELY 1.5¿ FROM THE PUMP HOUSING AND THE SEVERED PORTION OF THE DRIVELINE WAS NOT RETURNED. THE SEALED INFLOW CONDUIT, THE SEALED OUTFLOW GRAFT AND THE OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED. THE OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP OUTLET PORT. UPON DISASSEMBLY OF THE PUMP, VISUAL EXAMINATION OF THE DISTAL-SIDE OF THE INLET STATOR AND THE BLOOD TUBE/ROTOR INLET SECTION REVEALED A DENATURED THROMBUS RING ADHERED TO THE INLET BEARING BALL AND THE INLET SECTION OF THE ROTOR. THE INLET BEARING CUP WAS UNSEATED DURING THE DISASSEMBLY PROCESS DUE TO THE ADHERED THROMBUS RINGS. A THROMBUS FORMATION, SIMILAR IN COLOR AND STRUCTURE, WAS FOUND IN BETWEEN TWO OF THE BLADES OF THE ROTOR. THE RINGS APPEARED TO FORM IN LAMINATED LAYERS, WHICH IS AN INDICATION THAT THEY DEVELOPED OVER AN UNDETERMINED AMOUNT OF TIME WHILE THE PUMP WAS OPERATING. THE THROMBUS FOUND IN THE PUMP WOULD HAVE CONTRIBUTED TO THE REPORTED HEMOLYSIS; HOWEVER, THE REPORT OF A MALPOSITIONED INFLOW CONDUIT COULD NOT BE CONFIRMED AS THE INFLOW CONDUIT WAS NOT RETURNED AND NO X-RAYS OF THE MALPOSITIONING WERE AVAILABLE TO THE MANUFACTURER. THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ABNORMALITIES WERE FOUND. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA FROM OUR 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 THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP. THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT UNDERWENT AN ABDOMINAL SURGERY DAYS AFTER IMPLANTATION AND THAT AFTER THE ABDOMINAL SURGERY, THE POSITION OF THE INFLOW CONDUIT HAD CHANGED TOWARDS THE ARTERIAL WALL AND THE DEVICE WAS NOT ABLE TO UNLOAD THE LEFT VENTRICLE SUFFICIENTLY. THE PT WAS MOVED TO THE NORMAL WARD BUT HAD NOT MADE ANY PROGRESS IN PHYSICAL MOVEMENT. ON (B)(6) 2014, THE PT DEVELOPED HEMOLYSIS AND THE HOSPITAL REPLACED THE PUMP ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243867 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 131478

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention