BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 2921615 · Received January 15, 2013

    Report

    Report Number
    8022247-2013-00001
    Event Type
    Death
    Date Received
    January 15, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 15, 2013
    Manufacturer
    MDS NORDION
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT TIME OF ADMISSION TO HOSPITAL ON (B)(6) FOR CONFUSION THE PATIENT SHOWED HIGH LEVELS OF UREA, TROPONIN, AMMONIA, HIGH INR AND HIGH PROTHROMBIN TIME, AS WELL AS AN ALTERED LIVER PROFILE SHOWING EXTREMELY HIGH LEVELS OF BILIRUBIN, ALANINE AMINOTRANSFERASE AND ALKALINE PHOSPHATASE. THE MOST RECENT BLOOD TESTS (INCLUDING LIVER PROFILE) AVAILABLE FROM BEFORE TREATMENT WITH THERASPHERE WERE DONE 1 MONTH BEFORE TREATMENT SO THE PATIENT'S BASELINE LIVER FUNCTION IS UNK. A CAUSE OF DEATH IS NOT AVAILABLE AT THIS TIME. IT IS VERY DIFFICULT TO ASSESS POTENTIAL RELATEDNESS OF THERASPHERE TREATMENT TO THE DEATH IN THIS PATIENT WITHOUT FURTHER INFO REGARDING BASELINE LIVER FUNCTION AND LIVER TEST RESULTS AND WITHOUT DETAILS SURROUNDING THE DEATH OF THE PATIENT.

    Description of Event or Problem · 1

    A PATIENT ENROLLED IN AN INVESTIGATOR INITIATED STUDY (IIS) FOR THERASPHERE AND SORAFENIB AT (B)(6) HOSPITAL, WAS ADMITTED TO THE HOSPITAL FOR CONFUSION 3 DAYS AFTER THERASPHERE TREATMENT AND PASSED AWAY 9 DAYS AFTER TREATMENT. THE PATIENT RECEIVED THERASPHERE ADMINISTRATION ON (B)(6) 2012 DURING AN UNEVENTFUL PROCEDURE AND WAS DISCHARGED THE SAME DAY. HE PRESENTED TO (B)(6) HOSPITAL EMERGENCY ROOM ON (B)(6) 2012 VERY CONFUSED. BLOOD TESTS WERE DONE BEFORE THE PATIENT WAS TRANSFERRED TO A SEPARATE HOSPITAL WHERE HE DIED ON (B)(6) 2012. THE PATIENT HAD BEEN DIAGNOSED WITH HCC AND HAD BEEN TAKING SORAFENIB 400MG BID SINCE (B)(6) 2012. ADD¿L INFO, INCLUDING TEST RESULTS, IS ATTACHED. A CAUSE OF DEATH IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21746 THERASPHERE YTTRIUM-90 MICROSPHERES NAW MDS NORDION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H