BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 2679368 · Received July 31, 2012

    Report

    Report Number
    8022247-2012-00011
    Event Type
    Death
    Date Received
    July 31, 2012
    Date of Event
    June 24, 2012
    Report Date
    July 30, 2012
    Manufacturer
    NORDION (CANADA) INC
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE INFO, CANNOT RULE OUT GI ULCERATION CAUSED BY THERASPHERE TREATMENT.

    Description of Event or Problem · 1

    (B)(6) MALE WITH HCC RECEIVED THERASPHERE TREATMENT (93.5 MCI 90;7 MCI DELIVERED TO LIVER 2.8 MCI CALCULATED OUTSIDE OF LIVER DUE TO SHUNTING) ON (B)(6) 2012. THE PT WAS ADMITTED TO HOSPITAL ON (B)(6) 2012, WITH ABDOMINAL PAIN AND ASCITES. HE WAS GIVEN DIURETICS AND PARACENTESIS AND DISCHARGED IN STABLE CONDITION. ON (B)(6) 2012, THE PT WAS RE-ADMITTED TO HOSPITAL "COUGHING UP BLOOD". THE PT DIED ON (B)(6) 2012. ADDITIONAL INFO INCLUDING TEST RESULTS: (B)(6) 2012, Y90 93.5 MCI 90;7 MCI DELIVERED TO LIVER 2.8 MCI CALCULATED OUTSIDE OF LIVER DUE TO SHUNTING. ON (B)(6), IP ADMISSION ADD PAIN AND ASCITES PLAN DIURETICS AND PARACENTESIS DISCHARGE IN STABLE CONDITION. ON (B)(6) 2012, ADMITTED TO LOCAL HOSPITAL IN (B)(6), WITH COUGHING UP OF BLOOD. NO OTHER INFO AVAILABLE.

    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 53 YR Death| H