BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3004031 · Received March 12, 2013

    Report

    Report Number
    2916596-2013-00261
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY. 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 MANUFACTURER RECEIVED A USER FACILITY REPORT FROM THE (B)(6) REGISTRY STATING THAT THE PATIENT WAS ADMITTED WITH HEMOLYSIS AND POSSIBLE THROMBUS. THE PATIENT WAS STARTED ON BIVALIRUDIN AND INTEGRILIN WHICH REPORTEDLY DID NOT RESULT IN SIGNIFICANT IMPROVEMENT IN THE PATIENT'S LDH. THE PATIENT WAS SUBSEQUENTLY MOVED TO THE INTENSIVE CARE UNIT AND A DOSE OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103848 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118912

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention