BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 5193570 · Received November 1, 2015

    Report

    Report Number
    2916596-2015-02055
    Event Type
    Injury
    Date Received
    November 1, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 5, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCREASE IN PUMP POWER AND DECREASE IN PI WAS CONFIRMED BASED ON THE SUBMITTED LOG FILE; HOWEVER, SPECIFIC CAUSES OF THE EVENTS AND A CORRELATION TO THE EVALUATION OF (B)(4) COULD NOT BE CONCLUSIVELY DETERMINED. UPON DISASSEMBLY OF THE RETURNED PUMP, LOOSELY SEATED DEPOSITIONS WERE PRESENT IN THE OUTLET STATOR. THE DEPOSITIONS WERE NOT ADHERED TO THE BEARING BALL OR THE STATOR BLADES, LACKED DENATURING AND LACKED LAMINATION. IN ADDITION, THERE WAS NO EVIDENCE OF CONTACT MARKS ON THE OUTLET BEARING CUP OR OUTLET/CONE SECTION OF THE ROTOR. ALTHOUGH THERE ORIGINS AND A DURATION IN WHICH THEY WERE PRESENT IN THE PUMP CANNOT BE CONCLUSIVELY DETERMINED, THE DEPOSITIONS DID NOT APPEAR TO HAVE ORIGINATED IN THIS LOCATION. EXAMINATION OF THE REMAINING BLOOD-CONTACTING SURFACES REVEALED NO DEPOSITIONS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE, REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE DEPOSITIONS. THE PUMP UNDERWENT CLEANING, REASSEMBLY AND FUNCTIONAL TESTING UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 8 MONTHS. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH ELEVATED PUMP POWERS, BUT DID NOT EXHIBIT ANY SYMPTOMS OF HEART FAILURE OR CHANGES IN HEMOLYSIS MARKERS. REVIEW OF THE DEVICE HISTORY SHOWED THAT THE PATIENT'S POWER AND FLOWS STARTED INCREASING OVER THE LAST 4-5 DAYS TO FLOWS IN THE 10 LPM RANGE AND POWERS IN THE 8 WATT RANGE. THE PATIENT'S INR WAS 2.9. THE PATIENT WAS TREATED WITH HEPARIN AS THE VAD TEAM FELT THE HIGH PUMP POWERS COULD BE DUE TO SUSPECTED DEVICE THROMBOSIS. THE PATIENT'S SYSTEM CONTROLLER WAS EXCHANGED TO RULE OUT AN EQUIPMENT ISSUE. THE PATIENT REMAINED IN THE HOSPITAL ON A HEPARIN INFUSION WITHOUT ANY RESOLUTION OF THE ELEVATED PUMP POWERS. ON (B)(6) 2015, THE PATIENT RECEIVED A PUMP EXCHANGE. POST-EXCHANGE THE PUMP POWERS RESOLVED. IT WAS REPORTED THAT NO OBVIOUS THROMBUS WAS OBSERVED IN THE PUMP AT EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724352 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R