BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6117817 · Received November 21, 2016

    Report

    Report Number
    2916596-2016-02275
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 27, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 6 MONTHS. THE PATIENT UNDERWENT A ROUTINE TRANSPLANT AND NO DEVICE RELATED ISSUES WERE REPORTED. THE EXPLANTED LVAD, VAD-18387, WAS RETURNED FOR EVALUATION. THE PUMP WAS RETURNED WITH THE PERCUTANEOUS LEAD CUT AT THE PUMP HOUSING. THE SEVERED PORTION WAS NOT RETURNED. THE SEALED INFLOW CONDUIT WAS RETURNED DETACHED AND THE PROXIMAL HALF WAS NOT RETURNED. THE SEALED OUTFLOW GRAFT WAS RETURNED AND SECURED TO THE OUTLET ELBOW. EXAMINATION OF THE PUMP BLOOD-CONTACTING SURFACES REVEALED TWO, SMALL RINGS OF THROMBUS AROUND THE INLET BEARING AND BEARING CUP. THE RINGS WERE COMPRISED OF A SINGLE LAYER AND SHOWED A SOFT STRUCTURE, INDICATING THE THROMBI WERE LIKELY ACUTE FORMATIONS. NO ADDITIONAL ADHERED DEPOSITIONS OR THROMBUS FORMATIONS WERE OBSERVED. VISUAL INSPECTION OF THE PUMP BEARINGS AND BEARING CUPS FOUND NO ANOMALIES RELATED TO WEAR OR DAMAGE. EXAMINATION OF THE RETURNED PORTION OF THE DRIVELINE FOUND IT TO BE UNREMARKABLE. ELECTRICAL CONTINUITY TESTING OF THE WIRES FOUND NO DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AND OPERATED ON A MOCK CIRCULATORY LOOP AND FUNCTIONED AS INTENDED. THE EVALUATION OF THE RETURNED DEVICE COULD NOT CONCLUSIVELY DETERMINE THE CAUSE OF THE INLET BEARING THROMBUS. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. 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) 2016. IT WAS REPORTED THAT ON (B)(6) 2016 THE PATIENT UNDERWENT A ROUTINE HEART TRANSPLANT. IT WAS REPORTED THAT THE TRANSPLANT WAS NOT DEVICE OR THERAPY RELATED. THE IMPLANTING CENTER REQUESTED AN EVALUATION OF THE EXPLANTED DEVICE. ON (B)(6) 2016, DURING THE INVESTIGATION OF THE RETURNED LVAD, THROMBUS WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769458 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR