BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 1980230 · Received February 1, 2011

    Report

    Report Number
    2916596-2011-00040
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF THROMBUS WAS CONFIRMED. THE EXAMINATION OF (B)(4) FOUND A RING OF THROMBUS AROUND THE INLET BEARING BALL. THE PORTION OF THE THROMBUS ADJACENT TO THE INLET BEARING APPEARED TO SHOW EVIDENCE OF LAYERING, INDICATING THAT TISSUE FORMED OVER AN INDETERMINATE PERIOD OF TIME. THE OUTER PORTION OF THE RING APPEARED TO BE A COMBINATION OF TISSUE-LIKE DEPOSITION AND COAGULATED BLOOD, INDICATING THAT THIS SECTION OF THE RING FORMED CLOSE TO THE TIME OF EXPLANT. THE INLET BEARING THROMBUS WOULD HAVE IMPEDED ROTOR ROTATION AND BLOOD FLOW THROUGH THE PUMP, CAUSING THE ELEVATED PUMP POWER CONSUMPTION AND THE OBSERVED LOW FLOW. THE ORIGINS OF THE THROMBUS COULD NOT BE DETERMINED. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS PUMP SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PERFUSIONIST REPORTED A POSSIBLE PUMP THROMBUS. SIGNS OF PUMP THROMBUS WERE NOTED IN THE ECHO. THE PATIENT'S EJECTION FRACTION HAD IMPROVED FROM 10-15% TO 45% SO THE PATIENT WAS NOT GIVEN A NEW PUMP. THE PATIENT WAS EXPLANTED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 96982

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention