BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 6167316 · Received December 12, 2016

    Report

    Report Number
    2916596-2016-02404
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 15, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 4 YEARS, 5 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE EXPLANTED DEVICE WAS RETURNED FOR EVALUATION. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE ROTOR INLET REVEALED THROMBUS FORMATIONS SURROUNDING THE BEARING CUP WITHIN THE DISTAL SIDE OF THE INLET STATOR, AS WELL AS THE ROTOR¿S BEARING BALL. THESE THROMBI APPEARED TO HAVE DEVELOPED AS ONE FORMATION THAT WAS PULLED APART AS A RESULT OF THE PUMP DISASSEMBLY PROCESS. THE LAMINATED STRUCTURE OF THESE THROMBI AND THEIR AREAS OF DENATURATION INDICATE THAT THEY LIKELY FORMED OVER AN UNDETERMINED PERIOD OF TIME WHILE THE PUMP WAS SUPPORTING THE PATIENT. ALTHOUGH A ROOT CAUSE FOR THE DEVELOPMENT OF THESE THROMBI COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION, THEY COULD HAVE CONTRIBUTED TO THE PATIENT¿S ELEVATED LACTATE DEHYDROGENASE LEVEL, AS WELL AS THE INCREASE IN PUMP POWER OBSERVED IN THE SUBMITTED SYSTEM CONTROLLER LOG FILE. UPON REMOVAL OF THE OBSERVED DEPOSITIONS, 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. DEVICE THROMBOSIS AND HEMOLYSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2012. IT WAS REPORTED THAT AFTER OVER 4 YEARS OF SUPPORT, THE PATIENT WAS ADMITTED WITH HEMOGLOBIN IN THE URINE AND RISING LACTATE DEHYDROGENASE (LDH) LEVELS. SYSTEM CONTROLLER LOG FILES REVIEWED BY THE MANUFACTURER¿S TECHNICAL SERVICES REPRESENTATIVE SHOWED AN INCREASE IN PUMP POWER OVER TIME. THE PATIENT WAS HEPARINIZED. LVAD FLOW HAS REPORTEDLY BEEN ADEQUATE, AND THE PATIENT¿S LDH LEVEL HAS PLATEAUED ALTHOUGH STILL ELEVATED. THE PATIENT WAS UPGRADED TO STATUS 1A FOR TRANSPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT RECEIVED A HEART TRANSPLANT ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817312 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R