BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 2162132 · Received July 11, 2011

    Report

    Report Number
    8022247-2011-00003
    Event Type
    Death
    Date Received
    July 11, 2011
    Date of Event
    May 25, 2011
    Report Date
    July 8, 2011
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS REPORT IS BEING SENT BY COURIER DUE TO AN ONGOING PROBLEM WITH OUR ELECTRONIC SUBMISSION GATEWAY ACCOUNT WHICH WE WERE UNABLE TO RESOLVE BEFORE THE REPORTING DEADLINE.

    Description of Event or Problem · 1

    A PT ENROLLED IN AN INVESTIGATOR INITIATED STUDY OF THERASPHERE FOR PRIMARY OR METASTATIC USE DIED APPROX 2 WEEKS FOLLOWING THERASPHERE TREATMENT. THE PT WAS ADMITTED TO HOSPITAL WITH PAINLESS HEMATEMESIS AND HEMATOCHEZIA 6 DAYS FOLLOWING THERASPHERE TREATMENT. UPPER ENDOSCOPIES AND A COLONOSCOPY WERE PERFORMED REVEALING GASTRIC AND RECTAL VARICES AND NO GASTRODUODENAL ULCERS. CT ANGIOGRAM, NUCLEAR MEDICINE BLEEDING SCAN, AND CONVENTIONAL ANGIOGRAM DID NOT SHOW AN ARTERIAL SOURCE FOR THE BLEEDING. AFTER TEMPORARY CONTROL, GI BLEEDING RESUMED AND THE PT DIED FROM CARDIAC ARREST.

    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 Death| H