BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2496403 · Received March 15, 2012

    Report

    Report Number
    2916596-2012-00232
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 16, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. 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). THE VAD PROGRAM ADMINISTRATOR REPORTED THAT THE PATIENT RECEIVED A PUMP EXCHANGE DUE TO A DRAMATIC INCREASE IN LACTATE DEHYDROGENASE (LDH) LEVELS. UPON DEVICE EXPLANT, THE HOSPITAL REPORTED THAT THERE WERE SOME BLOOD CLOTS AROUND THE DEVICE BUT NO THROMBUS WAS NOTED. THE OUTFLOW GRAFT BEND RELIEF WAS REPORTEDLY DISENGAGED AND THE GRAFT WAS KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111119

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention