BEUDAMED
    FDA Adverse Event Other Summary report: N

    THERASPHERE

    MDR report key: 2434673 · Received January 26, 2012

    Report

    Report Number
    8022247-2012-00004
    Event Type
    Other
    Date Received
    January 26, 2012
    Date of Event
    December 10, 2011
    Report Date
    January 25, 2012
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NORDION IS COMMUNICATING WITH THE USER FACILITY TO DETERMINE WHY THE PT WAS NOT EMBOLIZED PRIOR TO THE SECOND TREATMENT AS IS RECOMMENDED.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED INTO THE HOSPITAL IN (B)(6), FOR SEVERE UPPER GASTRIC PAIN. THE ENDOSCOPY DID NOT REVEAL A SOURCE FOR HIS PAIN, BUT THE BIOPSY REVEALED "MARKED MUCOSAL NECROSIS" THAT WAS ASSOCIATED WITH INFLAMMATION AND CALCIFICATION; THE PRESENCE OF THE CALCIFICATION WAS CONCERNING FOR GASTRIC INVOLVEMENT FROM THE THERASPHERE TREATMENT. THE PT WAS TREATED (B)(6) 2011 (LEFT LOBE) AND (B)(6) 2011 (RIGHT LOBE). THE RIGHT GASTRIC AND GASTRODUODENAL ARTERIES WERE BOTH EMBOLIZED PRIOR TO HIS FIRST THERASPHERE TREATMENT, THE MAA SCAN WAS ALSO NORMAL.

    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 Required Intervention