BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3948885 · Received June 20, 2014

    Report

    Report Number
    2916596-2014-00836
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE (B)(4) REGISTRY. THE USER FACILITY NUMBER WAS NOT PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE REPORTED THROMBUS WAS CONFIRMED DURING THE EVALUATION. THE EXAMINATION OF THE ROTOR INLET UPON DISASSEMBLY REVEALED THROMBUS FORMATIONS SURROUNDING THE BEARING CUP WITHIN THE DISTAL SIDE OF THE INLET STATOR, AS WELL AS THE BEARING BALL OF THE ROTOR. 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. THE EXAMINATION OF THE ROTOR UPON DISASSEMBLY REVEALED A FLAT, DENATURED, TISSUE-LIKE DEPOSITION BETWEEN THE ROTOR BLADES. AREAS OF THIS DEPOSITION WERE HARD AND DENATURED, INDICATING THAT IT WAS LIKELY PRESENT WHILE THE PUMP WAS SUPPORTING THE PATIENT; HOWEVER, ITS LACK OF LAMINATION SUGGESTS THAT IT MAY HAVE DEVELOPED ELSEWHERE. ALTHOUGH THE ORIGIN OF THIS DEPOSITION COULD NOT CONCLUSIVELY BE DETERMINED, IT COULD HAVE CAUSED RESISTANCE ON THE SPINNING ROTOR, RESULTING IN THE REPORTED POWER ELEVATIONS AND MOTOR STOPPAGES WHICH WERE CONFIRMED THROUGH THE EVALUATION OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE. A THROMBUS FORMATION WAS ALSO OBSERVED WITHIN THE PROXIMAL SIDE OF THE OUTLET STATOR. ALTHOUGH THE DURATION FOR WHICH THIS FORMATION WAS PRESENT IN THIS LOCATION COULD NOT BE DETERMINED, SIMILARITIES IN TEXTURE AND DENATURATION INDICATE THIS FORMATION MAY HAVE ORIGINALLY FORMED AS PART OF THE THROMBUS OBSERVED ALONG THE ROTOR BODY. ALTHOUGH A SPECIFIC CAUSE FOR THE DEVELOPMENT OF THE OBSERVED FORMATIONS COULD NOT CONCLUSIVELY BE DETERMINED, THEY COULD HAVE CONTRIBUTED TO THE PATIENT¿S REPORTED HEMOLYSIS, POWER ELEVATIONS, AND MOTOR STOPPAGES. UPON REMOVAL OF THE OBSERVED DEPOSITIONS, THE PUMP 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 RETURNED PORTION 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. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MANUFACTURER FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THE TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT HAD A PUMP OFF EVENT. THE PT HAD HEMOLYSIS WITH ELEVATED POWER AND FLOW. THE LOG FILE CONFIRMED THE PUMP STOPPAGE EVENT. THE PUMP WAS EXPLANTED AND EXCHANGED DUE TO ONGOING HEMOLYSIS. THROMBUS WAS WITNESSED ON THE BEARING UPON DEVICE EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(4) REGISTRY STATING: PT. HAD A PUMP OFF EVENT ON (B)(6) 2014. TTE SHOWED DEFINITE SIGNS OF PUMP THROMBOSIS. ABNL VAD FXN. LA THROMBUS FOUND IN LVAD EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363175 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 138290

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention