BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 2431761 · Received January 26, 2012

    Report

    Report Number
    8022247-2012-00002
    Event Type
    Death
    Date Received
    January 26, 2012
    Date of Event
    October 29, 2011
    Report Date
    January 25, 2012
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED THERASPHERE ADMINISTRATION ON (B)(6) 2011, AND SUBSEQUENTLY COMPLAINED OF SEVERE FATIGUE AND FLUID RETENTION. HIS SERUM BILIRUBIN CONTINUED TO RISE AND HE WAS ADMITTED ON (B)(6) 2011 FOR SEVERE FATIGUE, LIVER FAILURE AND KIDNEY INJURY. THE PATIENT PASSED AWAY ON (B)(6) 2011 DUE TO LIVER FAILURE. THE TREATING PHYSICIAN HAS STATED THAT HE BELIEVES THE TIME COURSE (ALMOST IMMEDIATE ONSET OF LIVER DETERIORATION) IS ATYPICAL FOR RILD (RADIATION INDUCED LIVER DISEASE), ESPECIALLY GIVEN THAT THEY DID NOT TREAT THE RIGHT LOBE WHICH WAS THE MAJORITY OF HIS LIVER. HE ALSO DEVELOPED PORTAL VEIN OCCLUSION WHICH THE PHYSICIAN BELIEVES PROBABLY CONTRIBUTED SIGNIFICANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASPHERE YTTRIUM-90 MICROSPHERES NAW NORDION (CANADA) INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H