BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 2987540 · Received February 27, 2013

    Report

    Report Number
    8022247-2013-00002
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 27, 2013
    Manufacturer
    NORDION (CANADA) INC.
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NORDION PHYSICIAN AGREES WITH THE TREATING PHYSICIAN THAT THE EVENT WAS PROBABLY CAUSED BY THE INADVERTENT DEPOSITION OF MICROSPHERES INTO THE CYSTIC ARTERY ALTHOUGH THIS WAS NOT CONFIRMED. GENERALLY THE CYSTIC ARTERY IS NOT COILED AND DEPOSITION OF MICROSPHERES DOES NOT LEAD TO CHOLECYSTITIS OR CHOLECYSTECTOMY BUT GIVEN THE ACUTE NATURE OF THE EPISODE AND THE TIMING IN RELATION TO TREATMENT WITH THERASPHERE IT IS REASONABLE TO ASSUME A CONNECTION.

    Description of Event or Problem · 1

    A WOMAN WITH A HISTORY OF OVARIAN CANCER DEVELOPED CHOLECYSTITIS APPROXIMATELY 3 WEEKS AFTER HER SECOND THERASPHERE TREATMENT. SHE WAS TREATED WIT IV FLUIDS AND PAIN MEDICATION AND WAS RELEASED AFTER INITIALLY RESPONDING WELL TO TREATMENT. SEVERAL WEEKS LATER, THE PATIENT'S SYMPTOMS WORSENED AND SHE WAS TREATED WITH A CHOLECYSTOTOMY TUBE ON (B)(6) 2012 BUT EVENTUALLY UNDERWENT A CHOLECYSTECTOMY ON (B)(6) 2013. SHE WAS DISCHARGED HOME BUT HER POST-OP COURSE WAS COMPLICATED BY A BILE LEAK WHICH WAS TREATED AND THE PATIENT RELEASED. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013 FOR ABDOMINAL PAIN AND NAUSEA AND WAS HYDRATED AND SENT HOME. ON (B)(6), THE PATIENT AGAIN PRESENTED TO EMERGENCY ROOM WITH ABDOMINAL PAIN AND INTRACTABLE NAUSEA AND VOMITING. IMAGING REVEALED FLUID COLLECTION AND AIR WHICH ALONG WITH AN ELEVATED WBC COUNT SUGGESTED AN ABSCESS. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND PAIN MEDICATION UNTIL SHE WAS DISCHARGED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85426 THERASPHERE YTTRIUM-90 MICROSPHERES NAW NORDION (CANADA) INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L