BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5222173 · Received November 13, 2015

    Report

    Report Number
    2916596-2015-02113
    Event Type
    Injury
    Date Received
    November 13, 2015
    Date of Event
    August 13, 2015
    Report Date
    October 15, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED PUMP EXCHANGE DUE TO THROMBUS WAS REPORTED UNDER MEDWATCH MFR# 2916596-2015-01539. (B)(4). APPROXIMATE AGE OF DEVICE ¿ 14 DAYS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WAS NOT RETURNING FOR EVALUATION. THE DEVICE WAS SUBSEQUENTLY RECEIVED. THE REPORT OF THROMBUS WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED PUMP. EXAMINATION OF THE SEALED INFLOW CONDUIT REVEALED A NON-LAMINATED DEPOSITION SITUATED ON THE TEXTURED BLOOD-CONTACTING SURFACE OF THE INLET TUBE. SIMILAR DEPOSITIONS WERE FOUND IN THE LUMENS OF THE INLET ELBOW AND OUTFLOW ELBOW. ALTHOUGH SPECIFIC CAUSES FOR THEIR DEVELOPMENT COULD NOT BE CONCLUSIVELY DETERMINED, THE DEPOSITIONS APPEARED TO HAVE DEVELOPED IN THESE AREAS; HOWEVER, THE DEPOSITIONS DID NOT APPEAR TO OCCLUDE THE FLOW OF BLOOD THROUGH THE PUMP. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE PUMP BLOOD-CONTACTING SURFACES REVEALED NO DEPOSITIONS. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE REVEALED NO ABNORMALITIES. THE PUMP UNDERWENT CLEANING, REASSEMBLY AND FUNCTIONAL TESTING UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA REVEALED NORMAL PUMP POWER CONSUMPTION VALUES, COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MANUFACTURING PROCESS, AND THE PUMP OPERATED AS INTENDED. DEVICE THROMBOSIS IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. 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). IT WAS REPORTED THAT THE PATIENT WAS UPGRADED ON THE TRANSPLANT LIST DUE TO PUMP THROMBOSIS. THE PATIENT UNDERWENT A TRANSPLANT ON (B)(6) 2015. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752362 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R