BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 454275 · Received April 16, 2003

    Report

    Report Number
    MW1028156
    Event Type
    Death
    Date Received
    April 16, 2003
    Date of Event
    July 4, 2002
    Report Date
    April 4, 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 02-2002 AND RECEIVED 154 GY. IN 03-2002, THEIR TREATMENT WAS COMPLETED WITH THE LEFT LOBE INFUSION OF 128 GY. BOTH PROCEDURES WENT WELL AND THE PT WS DISCHARGED TO HOME IN STABLE CONDITION EACH TIME. IN 4-2002 CT SHOWED DISEASE PROGRESSION WITH INCREASE IN SIZE OF HEPATIC LESIONS. PET SCAN FROM 5-2002 REVEALED PARTIAL IMPROVEMENT IN THE LIVER, BUT DISEASE PROGRESSION IN THE MEDIASTINUM, AREA NEAR THE THORACIC SPINE, BASE OF THE SKULL AND TO THE LEFT OF L5. ANOTHER SIGN OF DISEASE PROGRESSION WAS THE CEA INCREASE FROM 35.3 NG/ML IN 03-2002 TO 56.2 NG/ML ON 04/2002. 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 73 YR Death