BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERASPHERE

    MDR report key: 2433539 · Received January 17, 2012

    Report

    Report Number
    8022247-2012-00001
    Event Type
    Other
    Date Received
    January 17, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 16, 2011
    Manufacturer
    NORDION (CANADA) INC
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REQUIRED HOSPITALIZATION IN ORDER TO RE-HYDRATE TO UNDERGO IMAGING. BLOOD TESTS REVEALED ELEVATED BILIRUBIN AND CREATININE.

    Description of Event or Problem · 1

    A PT WITH ADVANCED COLON CANCER WITH METASTATIC LIVER LESIONS ENROLLED IN A (B)(4) STUDY OF THERASPHERE EXPERIENCED JAUNDICE AND LETHARGY ABOUT (B)(6) WEEKS AFTER TREATMENT OF LEFT HEPATIC LOBE (PREVIOUS TREATMENT OF RIGHT HEPATIC LOBE ON (B)(6) 2011) AND WAS ADMITTED TO HOSP. THE PT HAD BEEN EXPERIENCING RIGHT UPPER QUADRANT PAIN AND OCCASIONAL VOMITING AND NAUSEA PRIOR TO TREATMENT AND THIS CONTINUED AFTER TREATMENT. DUE TO BEING UNABLE TO KEEP DOWN FOOD OR LIQUIDS AND JAUNDICE AND LETHARGY THE PT WAS ADMITTED TO HOSP ON (B)(6). BLOOD TESTS REVEALED BILIRUBIN OF 7.1 AND CREATININE OF 3.2. THE PT WAS RECEIVING HYDRATION TO IMPROVE LIVER FUNCTION AND THEN WILL UNDERGO IMAGING. UPDATE: THE PT WAS ADMITTED FOR HYDRATION, THEN DISCHARGED (B)(6) 2011. AS OF (B)(6) 2012, HIS "LAB VALUES ARE UP" AND HE WAS TO START A NEW SYSTEMIC CHEMOTHERAPY REGIMEN WITH HIS ONCOLOGIST. ACCORDING TO PROTOCOL, HE WAS EXITED HIM FROM THE STUDY. THE TREATING PHYSICIAN BELIEVES THAT THIS IS PROGRESSION OF DISEASE, BASED ON HIS HISTORY AND INFO PROVIDED TO THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERASPHERE YTTRIUM-90 MICROSPHERES NAW NORDION (CANADA) INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization