BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 458943 · Received May 12, 2003

    Report

    Report Number
    MW1028387
    Event Type
    Death
    Date Received
    May 12, 2003
    Date of Event
    April 29, 2002
    Report Date
    May 2, 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 09/2001 AND RECEIVED 147 GY. IN 11/2001, THEIR FIRST CYCLE OF TREATMENT WAS COMPLETED WITH THE LEFT LOBE INFUSION OF 134 GY. BOTH PROCEDURES WENT WELL AND THE PT WAS DICHARGED TO HOME IN STABLE CONDITION EACH TIME. CT SCAN FROM 01/2002 SHOWED DISEASE PROGRESSION IN THE LIVER AND NEW PULMONARY NODULES. PET SCAN FROM 01/2002 REVEALED IMPROVEMENT OF LESIONS IN THE LOBE OF THE LIVER WHILE LESIONS IN THE RIGHT LOBE APPEARED WORSE. THERE WERE ALSO THREE FOCI IN THE AREA OF THE GASTRIC LYMPH NODES AND ONE FOCUS IN THE MID-ABDOMEN. ANOTHER SIGN OF DISEASE PROGRESSION WAS CEA INCREASE FROM 3.2 NG/ML IN 11/2001 TO 11.1 NG/ML IN 01/2002. THE PT WAS RETREATED WITH THERASPHERE TO THE RIGHT LOBE OF THE LIVER AND RECEIVED 164 GY DURING AN UNEVENTFUL INFUSION IN 01/2002. BIOCHEMICAL RESPONSE WAS APPRECIATED WITH CEA DECREASING TO 7.5 NG/ML IN 02/2002. CT SCAN FROM 03/2002 SHOWED MIXED RESPONSE WITH SOME LIVER LESIONS APPEARING SMALLER AND OTHERS APPEARING LARGER. PET SCAN FROM 03-2002 SUGGESTED SLIGHT IMPROVEMENT IN THE RIGHT LOBE OF THE LIVER, BUT EXTRAHEPATIC PROGRESSION WITH NEW MEDIASTINAL LESION. AS A CONFIRMATION OF DISEASE PROGRESSION THE CEA INCREASED TO 15.5 NG/ML IN 03/2002. 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 56 YR Death