BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2872325 · Received December 11, 2012

    Report

    Report Number
    2916596-2012-01203
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED WITH THE PERCUTANEOUS LEAD CUT AT THE PUMP AND BEND RELIEF AND THE SEVERED PORTION WAS NOT RETURNED. THE SEALED INFLOW CONDUIT AND SEALED OUTFLOW GRAFT WERE RETURNED AND RECURRED TO THEIR RESPECTIVE PUMP PORTS. EXAMINATION OF THE PUMP BLOOD-CONTACTING SURFACES REVEALED RINGS OF THROMBUS ADHERED TO THE INLET BEARING AND INLET BEARING CUP. THE RINGS SHOWED SOME LAMINATED LAYERING, INDICATING THAT THE THROMBUS DEVELOPED AROUND THE BEARING OVER AN UNDETERMINED PERIOD OF TIME WHILE THE PUMP WAS SUPPORTING THE PT. ALTHOUGH THE ORIGIN OF THE OBSERVED THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED, THE DEPOSITIONS WOULD HAVE CONTRIBUTED TO THE REPORTED ELEVATIONS IN PUMP POWER. VISUAL AND MICROSCOPIC EXAMINATION OF THE PUMP BEARINGS AND BEARING CUPS DID NOT REVEAL ANY EVIDENCE OF WEAR OR ABNORMALITIES THAT WOULD HAVE AFFECTED THE FUNCTIONALITY OF THE PUMP. EXAMINATION OF THE RETURNED PORTION OF THE PERCUTANEOUS LED FOUND IT TO BE UNREMARKABLE AND THE ELECTRICAL CONTINUITY TESTING DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS CLEANED, REASSEMBLED AND FUNCTIONALITY TESTED UNDER VARIOUS LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP AND WAS FOUND TO OPERATES AS INTENDED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MFG OR QA SPECS. BASED ON OUR EVAL OF THE RETURNED PUMP, NO DEVICE RELATED ISSUES WERE FOUND AND NO CONCLUSION CAN BE MADE AS TO THE ROOT CAUSE OF THE OBSERVED THROMBUS FORMATION ADHERED TO THE INLET BEARING AND INLET BEARING CUP. THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE (B)(4) REGISTRY. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS TRANSPLANTED AFTER 2 MONTHS OF SUPPORT ON THE LVAD AN ANALYSIS OF THE EXPLANTED PUMP WAS REQUESTED BY THE HOSPITAL DUE TO ELEVATED PUMP POWER PRIOR TO THE TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 115378

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other