BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 2001612 · Received February 25, 2011

    Report

    Report Number
    8022247-2011-00001
    Event Type
    Death
    Date Received
    February 25, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 24, 2011
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    HDE H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPLANTATION NOT POSSIBLE.

    Description of Event or Problem · 1

    THE PATIENT WENT TO THE (B)(6) HOSPITAL IN (B)(6) ON (B)(6) 2010 AND WAS FOUND TO BE VERY JAUNDICED, DISORIENTED AND DISTRESSED. HE WAS ADMITTED FOR CARE AND BLOOD WORK REVEALED ELEVATED BILIRUBIN AND INR. THE PATIENT HAD RECEIVED DOSES OF THERASPHERE TO THE LIVER ON (B)(6) 2010 AND (B)(6) 2010 AND WAS TAKING SORAFENIB 200MG BID SINCE (B)(6) 2010. THESE ARE EXPECTED EVENTS FOR BOTH THERASPHERE AND SORAFENIB. PATIENT DIED OF SEPSIS AND HEPATIC FAILURE ON (B)(6) 2011. PATIENT WAS OFF SORAFENIB SINCE ADMISSION (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASPHERE RADIOACTIVE MICROSPHERES NAW NORDION (CANADA) INC. 990700.SPE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death SORAFENIB