BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 2700177 · Received August 13, 2012

    Report

    Report Number
    8022247-2012-00012
    Event Type
    Injury
    Date Received
    August 13, 2012
    Date of Event
    July 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE TIME SINCE TREATMENT, IT APPEARS THAT THERASPHERE TREATMENT MOST LIKELY CONTRIBUTED TO THE FATIGUE AND ANOREXIA THAT NECESSITATED HOSPITALIZATION. THESE ARE IDENTIFIED SIDE EFFECTS OF THERASPHERE AND HOSPITALIZATION MAY HAVE BEEN AVOIDED IF THE PT HAD SOUGHT OUT TREATMENT EARLIER.

    Description of Event or Problem · 1

    A (B)(6) MALE PT WITH COLORECTAL CARCINOMA WITH METS TO THE LIVER RECEIVED THERASPHERE TREATMENT (120.17 GY TO RIGHT LIVER LOBE) ON (B)(6) 2012. THE PT HAD SEVERE FATIGUE, WHICH COULD HAVE BEEN TREATED WITH THE MEDROL DOSE PACK, BUT BY THE TIME HE PRESENTED TO THE HOSPITAL, HE HAD DECREASED APPETITE, WEIGHT LOSS, WAS UNWELL, AND REQUIRED ADMISSION TO THE HOSPITAL. THE PT IS ALSO RECEIVING FOLFOX FOR TREATMENT OF COLORECTAL CARCINOMA. DOSE ADMINISTERED AND DATE: THERASPHERE 120.17 GY TO RIGHT LIVER LOBE. THE DATE SYMPTOMS FIRST APPEARED: (B)(6) 2012. HCC OR METASTATIC USE AND STAGE/SIZE OF TUMOR: PT HAS COLORECTAL CARCINOMA WITH METS TO THE LIVER. PRIMARY LESION WAS A 4 CM COLONIC ADENOCARCINOMA LOCATED IN THE HEPATIC FLEXURE. MULTIPLE PULMONARY AND HEPATIC METASTASES. STAVE IV. PT DEMOGRAPHICS: W/M; DOB (B)(6); INITIALS (B)(6).

    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 65 YR Hospitalization LOTREL| RANITIDINE| TPN| GLIPIZIDE| VALSARTAN| PERCOCET| FOLFOX| METFORMIN| COUMADIN