BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 455097 · Received April 21, 2003

    Report

    Report Number
    MW1028192
    Event Type
    Death
    Date Received
    April 21, 2003
    Date of Event
    March 13, 2002
    Report Date
    April 1, 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 THE RIGHT LOBE OF THEIR LIVER IN 06-2001 AND RECEIVED 151 GY. IN 7-2001, THEIR TREATMENT WAS COMPLETED WITH THE LEFT LOBE INFUSION OF 149 GY. INITIALLY, THE PT HAD A GOOD RESPONSE TO THE TREATMENT WITH MEASURABLE SIZE DECREASE OF LIVER TUMORS (CT SCAN FROM 08-2001, PET SCAN FROM 08-2001). IN 11-2001 CT SHOWED DISEASE PROGRESSION WITH NEW TUMORS IN THE LIVER AND NEW, BULKY ADENOPATHY AT THE PORTA HEPATIS. ANOTHER SIGN OF DISEASE PROGRESSION WAS THE CEA INCREASE FROM 1873 NG/ML IN 08-2001 TO 2982 NG/ML IN 10-2001. THE PT EXPIRED IN 2002. THIS DEATH IS NOT RELATED TO THERASPHERE TREATMENT; IT IS DUE TO HEPATIC AND EXTRAHEPATIC DISEASE PROGRESSION.

    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 43 YR Death