BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERASPHERE

    MDR report key: 2484824 · Received March 6, 2012

    Report

    Report Number
    8022247-2012-00006
    Event Type
    Other
    Date Received
    March 6, 2012
    Date of Event
    January 4, 2012
    Report Date
    March 2, 2012
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL BECAUSE OF JAUNDICE ABOUT 3 WEEKS AFTER THERASPHERE TREATMENT. PATIENT WAS TAKING NEXAVAR 400 MG BID AND SHOWED ELEVATED BILIRUBIN AND ASCITES. AN ABDOMINAL CT SCAN WAS PERFORMED ON (B)(6) 2012 WITH A REPORT OF PROGRESSIVE INTRAHEPATIC BILE DUCT DILATATION AND A TRANSITIONAL ZONE AT THE CONFLUENCE OF THE RIGHT AND LEFT HEPATIC DUCTS. AN ERCP WAS PERFORMED ON (B)(6) 2012, TO PLACE A STENT IN THE DISTAL LEFT HEPATIC DUCT. PATIENT WAS DISCHARGED ON (B)(6) 2012. THE PATIENT IS PART OF AN (B)(6) FOR THERASPHERE AND SORAFENIB BEING PERFORMED AT (B)(6) UNIVERSITY AND (B)(6) HOSPITAL AND HAS BEEN TAKING SORAFENIB SINCE (B)(6), 2011.

    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 52 YR Hospitalization