BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE 20 GBQ

    MDR report key: 399379 · Received June 7, 2002

    Report

    Report Number
    8022247-2002-00021
    Event Type
    Death
    Date Received
    June 7, 2002
    Date of Event
    November 11, 2000
    Report Date
    June 3, 2002
    Manufacturer
    MDS NORDION, INC.
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED A 138 GY DOSE OF THERASPHERE (TS) VIA HEPATIC ARTERY INFUSION IN 2000 AND WAS RELEASED THE SAME DAY. THE NEXT MONTH, THE PATIENT HAD SYMPTOMS OF DIFFUSE ABDOMINAL PAIN, FEVER, CHILLS, NIGHT SWEATS AND VOMITING. THE PATIENT WAS ADMITTED 40 DAYS POST-TREATMENT. PHYSICAL EXAM REVEALED A DIFFUSELY TENDER LIVER, ASCITES AND HEPATOSPLENOMEGALY. A NON-CONTRAST CT CONDUCTED ON THE FOLLOWING DAY INDICATED DIFFUSE DISEASE WITH NUMEROUS BULKY MASSES AND OMENTAL CAKING NOT OBSERVED IN PREVIOUS EVALUATIONS. PERICENTESIS CONFIRMED A HEMOPERITONEUM AND BLOOD CULTURES REVEALED GRAM NEGATIVE BACTEREMIA. CLINICAL SIGNS OF MENINGITIS INCLUDED HEADACHE, STIFF NECK, NAUSEA AND VOMITING. A LUMBAR PUNCTURE REVEALED WBC BUT NO BACTERIA (CSF CULTURE NEGATIVE). THE PATIENT HAD BEEN ON IV ANTIBIOTIC FOR 48 HRS AT THE TIME. THE PATIENT ALSO RECEIVED 3 UNITS OF PACKED RBC FOR LOW HEMATOCRIT, WHICH RESPONDED TO TREATMENT. A RADIONUCLIDE ANGIOGRAM ON A LATER DATE DID NOT IDENTIFY ANY SITE OF ACTIVE BLEEDING. THE PATIENT WAS DISCHARGED A WEEK LATER AND REMAINED ON ANTIBIOTICS FOR TWO WEEKS, DURING WHICH TIME ALL SYMPTOMS RESOLVED. THE PATIENT WAS RE-ADMITTED ALMOST A MONTH LATER COMPLAINING OF LEFT ARM WEAKNESS. A CT SCAN REVEALED DISSEMINATION OF TUMOR TO THE UPPER THORACIC VERTEBRAL BODIES. THE PATIENT WAS DISCHARGED TO HOSPICE AND DIED AT HOME OF DISSEMINATED DISEASE. THE CLINICIAN JUDGED THE DEATH TO BE UNRELATED TO THERASPHERE TREATMENT DUE TO DISSEMINATED METASTATIC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASPHERE 20 GBQ RADIOACTIVE GLASS MICROSPHERES KXK MDS NORDION, INC. * 990003

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death