BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1990657 · Received February 8, 2011

    Report

    Report Number
    2916596-2011-00061
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PUMP WAS RETURNED ASSEMBLED WITH THE PERCUTANEOUS LEAD SEVERED APPROX 6" FROM THE PUMP END REINFORCING SLEEVE/BOOT AND THE REMAINDER OF LEAD WAS RETURNED. BOTH THE INLET AND OUTLET CANNULAE WERE RETURNED. THE PROXIMAL-SIDE OF THE INLET STATOR REVEALED EVIDENCE OF DEPOSITION INSIDE THE PUMP. THE REPORTED EVENT OF HEMOLYSIS AND SUSPECTED THROMBUS WAS CONFIRMED DURING THE ANALYSIS. THE EXAMINATION OF THE PUMP ROTOR INLET SECTION REVEALED A DARK, DENATURED THROMBUS SURROUNDING THE ROTOR INLET BEARING BALL AND INLET BEARING CUP. THE DEPOSITION APPEARED TO FORM IN LAMINATED LAYERS, WHICH IS AN INDICATION THAT IT GREW OVER AN UNDETERMINED AMOUNT OF TIME WHILE THE PUMP WAS IN OPERATION AND BECAME DENATURED DUE TO PROLONGED EXPOSURE TO BEARING HEAT. THE EXAMINATION OF THE PUMP INLET BEARINGS REVEALED NO UNUSUAL SURFACE WEAR OR DEFECTS THAT WOULD HAVE CONTRIBUTED TO THROMBUS FORMATION. THE THROMBUS FOUND AROUND THE PUMP ROTOR INLET WOULD HAVE AFFECTED THE BLOOD FLOW THROUGH THE DEVICE AND CONTRIBUTED TO THE REPORTED HEMOLYSIS. THE PUMP WAS CLEANED, REASSEMBLED AND FUNCTIONALLY TESTED UNDER LOADED CONDITIONS AND THE PUMP WAS FOUND TO OPERATE AS INTENDED DURING ALL TESTING. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE TRANSPLANT COORDINATOR THAT THE PT HAD CONTINUAL HEMOLYSIS, BLACK URINE AND LOW HEMATOCRIT WHICH REQUIRED MULTIPLE BLOOD TRANSFUSIONS. NO GI BLEED FOUND. A DECISION WAS MADE TO EXCHANGE THE LVAD WITH ANOTHER LVAD DUE TO SUSPECTED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention