BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 2846267 · Received October 19, 2012

    Report

    Report Number
    8022247-2012-00014
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    August 7, 2012
    Report Date
    October 19, 2012
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RADIATION PNEUMONITIS IS NOTED IN THE PI BUT IS A RARE SERIOUS ADVERSE EVENT. THE TREATING PHYSICIAN HAS INDICATED THAT HE FEELS THE EVENT TO BE PROBABLY RELATED TO THERASPHERE, AND THE NORDION PHYSICIAN AGREES. THE TIMING OF THE EVENTS SEEMS TO SUPPORT THE DIAGNOSIS OF RADIATION PNEUMONITIS BUT THIS IS A RARE EVENT FOR THERASPHERE. HAVE REQUESTED MORE RECENT LAB RESULTS TO UNDERSTAND HOW THE DIAGNOSIS OF RADIATION PNEUMONITIS WAS CONFIRMED. ALSO NEED TO KNOW WHAT THE PT'S LUNG SHUNT FRACTION (NOT SUPPLIED BY HOSPITAL) WAS TO UNDERSTAND THE CUMULATIVE DOSE TO THE LUNGS.

    Description of Event or Problem · 1

    THE PT WAS FIRST TREATED ON (B)(6) 2012 AND RECEIVED A 3.3 GBQ THERASPHERE DOSE TO THE LEFT LOBE OF THE LIVER. ON (B)(6) 2012 THE PT RECEIVED 4.2 GBQ DOSE TO THE RIGHT LOBE OF THE LIVER. THE PT WAS LAST SEEN AT CTCA-ERMC ON (B)(6) 2012 AND WAS ASYMPTOMATIC. TWO TO THREE WEEKS AFTER THE PT RETURNED HOME SHE DEVELOPED A COUGH AND SOB FOR WHICH SHE WAS HOSPITALIZED. CT SCAN PERFORMED ON (B)(6) 2012 SHOWED SUSPICION OF RADIATION PNEUMONITIS, TREATMENT INCLUDED ANTIBIOTICS AND STEROIDS. SHE SPOKE TO DR (B)(6) ON (B)(6) 2012 AND INDICATED THAT SHE HAD BEEN DISCHARGED FROM HOSPITAL BUT THERE WAS NO IMPROVEMENT TO HER SYMPTOMS, SHE CONTINUES TO HAVE SOB AND REMAINS ON SUPPLEMENTAL OXYGEN.

    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 63 YR Hospitalization FAMOTIDINE| AMBIEN