BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 2846280 · Received November 20, 2012

    Report

    Report Number
    8022247-2012-00015
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    March 8, 2012
    Report Date
    November 20, 2012
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS SERIOUS; EXPECTED, BUT INFREQUENT COMPLICATION OF Y90 RADIOEMBOLIZATION THERAPY, WHICH IS CAUSED BY EXTRAHEPATIC DEPOSITION OF RADIOACTIVE MICROSPHERES IN THE GUT.

    Description of Event or Problem · 1

    THE PT WAS TREATED WITH 120 GY OF THERASPHERE ON (B)(5) 2011. APPROX ONE MONTH FOLLOWING TREATMENT, HE DEVELOPED NAUSEA AND VOMITING. ENDOSCOPY ON (B)(6) 2012, REVEALED A GASTRIC ULCER (GRADE 2) WITH SIGNS OF HEALING. MEDICAL THERAPY WITH MEDICATION WAS INITIATED AND THE PT IMPROVED INITIALLY WITH AN UPPER ENDOSCOPY ONE MONTH LATER DEMONSTRATING PARTIAL HEALING, HOWEVER, ON (B)(6) 2012, THE PT DEVELOPED WORSENING ABDOMINAL PAIN AND PERITONEAL SIGNS. PT WAS ADMITTED TO HOSPITAL FOR IV NARCOTICS AND A REPEAT UPPER ENDOSCOPY DEMONSTRATED INCREASING ULCER DEPTH AND SIZE. THE PT WAS REFERRED TO A SURGEON AND ON (B)(6) 2012, HE UNDERWENT A DISTAL GASTRECTOMY (ANTRECTOMY) FOR NCI CTCAE GRADE 4 GASTRIC ULCER. THE PT DEVELOPED A COMPLICATION IN THE FORM OF AN ANASTOMOTIC LEAK, MANAGED WITH PERCUTANEOUS DRAINAGE AND REQUIRED TOTAL PARENTERAL NUTRITION FOR 6 WEEKS. THE PT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2012, AND ACHIEVED COMPLETE RECOVERY BY (B)(6). AS OF LAST F/U IN (B)(6) 2012, THE PT WAS FEELING WELL AND HAD NO SYMPTOMS RELATED TO GASTROINTESTINAL IRRITATION OR ULCERATION.

    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 Hospitalization| R