BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES

    MDR report key: 441762 · Received November 1, 2002

    Report

    Report Number
    9710358-2002-00001
    Event Type
    Injury
    Date Received
    November 1, 2002
    Date of Event
    October 3, 2002
    Report Date
    October 30, 2002
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A 1.8GBQ BRACHYTHERAPY IMPLANT OF SIR-SPHERES INTO BOTH LOBES OF THE LIVER IN 2002. THE IMPLANT WAS TO TREAT NON-RESECTABLE LIVER METASTASES FROM LARGE BOWEL CANCER. LIVER CONTAINED 3% TUMOR. PT DEVELOPED SYMPTOMS OF JAUNDICE & FEVER, AND HAD INCREASING LIVER FUNCTION TESTS (LFTS). PT SUBSEQUENTLY DIAGNOSED WITH CHOLANGITIS 2 MONTHS LATER, WHICH IS AN UNEXPECTED ADVERSE EVENT FROM TREATMENT WITH SIR-SPHERES. TREATING PHYSICIAN DOES NOT SUSPECT A RELATIONSHIP BETWEEN THE CONCURRENT CHEMOTHERAPY AND THE ADVERSE EVENT, ALTHOUGH BOTH IRINOTECAN AND 5-FLUOROURACIL ARE KNOWN RADIOSENSITISERS. IN 10/2002 THE INITIATOR REPORTED THE PT HAD CHOLETHIASIS AND CHOLECYSTITIS, ALSO UNEXPECTED EVENTS. ON 10/14/2002 THE SIRTEX MEDICAL DIRECTOR ADVISED STEROIDS SHOULD BE COMMENCED TO SETTLE INFLAMMATION, AND A BIOPSY TO BE PERFORMED TO CONFIRM DIAGNOSIS OF RADIATION HEPATITIS, A KNOWN RISK OF TREATMENT. THIS IS THE CURRENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES RADIOACTIVE BRACHYTHERAPY IMPLANT KXK SIRTEX MEDICAL LIMITED SIR-Y001 23435

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization SEE ATTACHED LIST.