BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 2652157 · Received July 6, 2012

    Report

    Report Number
    8022247-2012-00007
    Event Type
    Death
    Date Received
    July 6, 2012
    Date of Event
    April 17, 2012
    Report Date
    July 6, 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

    THE PATIENT SHOWED SIGNS OF POSSIBLE LUNG PROBLEMS AFTER TREATMENT BUT THERE IS NO REASON TO SUSPECT RADIATION PNEUMONITIS GIVEN MEDICAL HISTORY INCLUDING COPD. RADIATION INDUCED LIVER DISEASE IS POSSIBLE BUT UNKNOWN BECAUSE IT IS NOT CLEAR IF THERE WAS TUMOR PROGRESSION. GIVEN THE INFORMATION WE CANNOT RULE OUT OR CONFIRM RADIATION-INDUCED LIVER DISEASE CAUSED BY THERASPHERE TREATMENT.

    Description of Event or Problem · 1

    IN A REVIEW OF HISTORICAL DATA, (B)(6) IDENTIFIED A PATIENT WHO THEY FELT MAY HAVE DEVELOPED RADIATION-INDUCED LIVER DISEASE. THE PATIENT WAS TREATED ON (B)(6) 2012 AND WAS ADMITTED TO HOSPITAL ON (B)(6) 2012, WITH SOB, LOWER EXTREMITIES AND FATIGUE AND SLEEPINESS. THE PATIENT WAS SUFFERING FROM AKI, FLUID OVERLOAD,(B)(6), AND (B)(6). THE PATIENT DIED (B)(6) DAYS LATER. CONDITIONS NOTED PRIOR TO DEATH WERE ALTERED MENTAL STATUS, UTI, PNEUMONIA, ACUTE KIDNEY INJURY, LIVER CIRRHOSIS AND HCC, COPD, AND HEPATIC ENCEPHOPATHY. RECORDS ON (B)(6) 2012, STATES PATIENT DNR STATUS TO HYPOTENSION. UNRESPONSIVENESS. PRESCRIBE DOSE WRITTEN DIRECTIVE 83.83 MCI (3.1 GBQ). A 2.99 GBQ (90.7MCI) TO RIGHT LOBE AND SEGMENT 4 WITHOUT COMPLICATION. THIS REPRESENTS 99.3% OF THE DRAWN DOSE AND 95.8% OF THE PRESCRIBED DOSE. PERFORMED BY (B)(6), MD. ADDENDUM: WITH 0.6% MCI RESIDUAL ACTIVITIES CALCULATED DOSE TO TARGET LIVER WAS 118.07 GY AND CALCULATED DOSE TO LUNG WAS 11.87 GY.

    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 61 YR Death| H