BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 2357669 · Received November 30, 2011

    Report

    Report Number
    8022247-2011-00004
    Event Type
    Death
    Date Received
    November 30, 2011
    Date of Event
    October 28, 2011
    Report Date
    November 30, 2011
    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

    Description of Event or Problem · 1

    A PATIENT TREATED WITH THERASPHERE ON FRIDAY (B)(6) 2011 DIED WITHIN 2 DAYS FROM INTRAPERITONEAL HEMORRHAGE, PRESUMABLY DUE TO TUMOR RUPTURE AS PER THE TREATING PHYSICIAN. THE PHYSICIAN STATED THAT THIS IS NOT AN UNUSUAL TERMINAL EVENT IN (B)(6) AND WAS NOT AWARE OF IT OCCURRING IN ASSOCIATION WITH RADIOEMBOLIZATION BUT THAT IT HAD BEEN REPORTED FOLLOWING CHEMOEMBOLIZATION. DEATH CERTIFICATE LISTS (B)(6) AS CAUSE OF DEATH AND "HEMORRHAGE IN PERITONEUM" AS THE SIGNIFICANT CONTRIBUTOR.

    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