BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4253063 · Received November 13, 2014

    Report

    Report Number
    2916596-2014-02077
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 0.75" FROM THE PUMP HOUSING, AND 18" OF THE DISTAL PORTION OF THE DRIVELINE WAS ALSO RETURNED. THE SEALED INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RETURNED ATTACHED TO THE PUMP'S INLET PORT. THE SEALED OUTFLOW CONDUIT (OUTFLOW GRAFT, OUTFLOW GRAFT BEND RELIEF, AND OUTFLOW ELBOW) WAS RETURNED ATTACHED TO THE PUMP'S OUTLET PORT. THE SEALED OUTFLOW GRAFT BEND RELIEF COLLAR WAS SUTURED IN PLACE AROUND THE OUTFLOW GRAFT NUT. ANALYSIS OF THE SEALED INFLOW AND OUTFLOW CONDUITS REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. EXAMINATION OF THE PUMP UPON DISASSEMBLY REVEALED A SMALL DEPOSITION ADJACENT TO THE BEARING BALL WITHIN THE PROXIMAL SIDE OF THE OUTLET STATOR. THIS DEPOSITION'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, THE ABSENCE OF DENATURATION SUGGESTS THAT IT DEVELOPED ACUTELY. HOWEVER, THE SLIGHT CONTACT MARKS AT THE DISTAL END OF THE ROTOR INDICATE THAT THIS DEPOSITION WAS PRESENT WHILE THE PUMP WAS SUPPORTING THE PATIENT. A CAUSE FOR THE FORMATION OF THIS DEPOSITION COULD NOT BE DETERMINED THROUGH THIS EVALUATION AND A CORRELATION TO THE PATIENT'S PRE-TRANSPLANT SYMPTOMS COULD NOT BE CONCLUSIVELY ESTABLISHED. 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 DRIVELINE 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.

    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 EXPERIENCED ISSUES WITH HEMOLYSIS. THE PATIENT'S LDH HAD BEEN 393-1198 FROM (B)(6) 2014. THE PATIENT RECEIVED A HEART TRANSPLANT ON (B)(6) 2014. THE PATIENT'S INR AT THE TIME OF TRANSPLANT WAS 2.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732977 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 128193

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention