BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3946285 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-01105
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 12, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF PUMP THROMBUS AND HEMOLYSIS WAS CONFIRMED BASED ON THE EVALUATION OF THE LVAD. SEVERAL SMALL, WHITE TISSUE-LIKE DEPOSITIONS WERE FOUND ON VARIOUS AREAS OF THE LUMEN OF THE OUTFLOW ELBOW. THE STRUCTURE OF THE DEPOSITIONS SUGGESTS THAT THEY DEVELOPED IN THIS LOCATION WHILE THE PUMP WAS SUPPORTING THE PATIENT. THE DEPOSITIONS WERE STRONGLY ADHERED TO THE LUMEN OF THE OUTFLOW ELBOW, WERE MINIMALLY OBSTRUCTIVE TO THE BLOOD FLOW PATH, AND DID NOT APPEAR TO HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. ADDITIONALLY, A TISSUE-LIKE DEPOSITION WAS FOUND IN THE OUTLET STATOR ADJACENT TO THE BEARING BALL AND ON TWO OF THE STATOR BLADES. THE TISSUE APPEARED TO HAVE BEEN EXPOSED TO A FIXATIVE AGENT (E.G. FORMALDEHYDE OR GLUTARALDEHYDE). THE DEPOSITION LACKED LAMINATED LAYERING, SUGGESTING THAT IT DID NOT DEVELOP IN THIS LOCATION. ALTHOUGH THE DEPOSITION SHOWED NO OBVIOUS SIGNS OF DENATURATION, SLIGHT CONTACT MARKS WERE NOTED ON THE OUTLET PORTION OF THE ROTOR, INDICATING THAT THE DEPOSITION WAS PRESENT WHILE THE PUMP WAS OPERATING. ALTHOUGH A SPECIFIC CAUSE FOR THE OBSERVED DEPOSITION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, IT WAS PARTIALLY OBSTRUCTING THE BLOOD FLOW PATH AND COULD HAVE CONTRIBUTED TO THE REPORTED HEMOLYSIS. EVALUATION OF THE INFLOW CONDUIT REVEALED THAT IT APPEARED TO HAVE BEEN ANGLED AGAINST THE LEFT VENTRICLE. SIGNIFICANT TISSUE GROWTH WAS PRESENT OVER THE OPENING OF THE INLET TUBE, OBSTRUCTING APPROXIMATELY 50% OF THE BLOOD FLOW PATHWAY. A CAUSE FOR THE POSITION OF THE INFLOW CONDUIT COULD NOT BE IDENTIFIED; HOWEVER, THE PARTIAL TISSUE OBSTRUCTION OVER THE INLET TUBE COULD HAVE ALSO POTENTIALLY CONTRIBUTED TO THE REPORTED HEMOLYSIS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD CONTACTING SURFACES DID NOT REVEAL ANY ANOMALIES. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE PERCUTANEOUS LEAD DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. FUNCTIONAL TESTING OF THE PUMP UNDER NORMAL OPERATING CONDITIONS REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO THE DATA RECORDED DURING THE MANUFACTURING PROCESS AND THE PUMP OPERATED AS INTENDED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE BIO-MED THAT THE PATIENT WAS EXPERIENCING HEMOLYSIS IN THE PUMP. THE PATIENT WAS PROCESSED FOR WORK UP FOR A HEART TRANSPLANT AND RECEIVED A TRANSPLANT ON (B)(6) 2014. AT TIME OF EXPLANT, A CLOT WAS FOUND IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393120 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 120264

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention