BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 2666895 · Received July 18, 2012

    Report

    Report Number
    8022247-2012-00009
    Event Type
    Injury
    Date Received
    July 18, 2012
    Date of Event
    May 8, 2010
    Report Date
    July 18, 2012
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN THE TIMING OF TACE, IT APPEARS MOST LIKELY THAT THE RUQ PAIN IS PART OF THE POST-EMBOLIZATION SYNDROME ASSOCIATED WITH THAT TREATMENT. HOWEVER, AS THERE IS NO EVIDENCE TO RULE OUT GASTRIC ULCER, IT REMAINS POSSIBLE THAT THIS AE COULD BE RELATED TO THERASPHERE.

    Description of Event or Problem · 1

    A (B)(6) MALE WITH (B)(6) WITH PREVIOUS LOBECTOMY UNDERWENT THERASPHERE TREATMENT (UNDER (B)(4)) ON (B)(6) 2010. CT (B)(6) 2010 SHOWED LEFT LIVER LOBE DISEASE PROGRESSION, AND HE UNDERWENT TACE ON (B)(6) 2010 WITH DOXORUBICIN ON LC BEADS. HE WAS HOSPITALIZED (B)(6) 2010 WITH EPIGASTRIC AND RUQ ABD PAIN. HE DID BETTER IN THE HOSPITAL AND WAS DISCHARGED, BUT ON (B)(6) 2010 HAD SEVERE DYSPNEA AND CHANGE IN MENTAL STATUS WAS DIAGNOSED WITH A PE, AND DRIED DURING THE NIGHT.

    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 58 YR Death| H TACE