BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 454269 · Received April 16, 2003

    Report

    Report Number
    MW1028155
    Event Type
    Death
    Date Received
    April 16, 2003
    Date of Event
    April 23, 2002
    Report Date
    April 14, 2003
    Manufacturer
    MDS NORDION
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT THERASPHERE TREATMENT TO THEIR LIVER IN 12-2000 AND RECEIVED 174 GY DURING UNEVENTFUL INFUSION. IN 10-2001 CT SHOWED DISEASE PROGRESSION WITH PROMINENT LYTIC LESION IN THEIR LEFT ACETABULUM/LEFT ILIAC BONE. THE PT NEVER RECEIVED ANY FURTHER THERAPY FOR THEIR HEPATOMA AND DIED IN 2002, 16 MONTHS POST THERASPHERE. ALTHOUGH MEDICAL RECORDS INCLUDING DEATH CERTIFICATE ARE INCOMPLETE FOR THE PERIOD IMMEDIATELY PRIOR TO THE PT'S DEATH, GIVEN THE PT'S UNDERLYING MEDICAL ILLNESSES (ACTIVE HEPATITIS C, CIRRHOSIS) AND DOCUMENTED EXTRAHEPATIC PROGRESSION IT IS NOT LIKELY THAT THERASHPERE WAS THE CAUSE OF THEIR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASPHERE RADIOACTIVE SOURCE KXK MDS NORDION NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death