BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 6224388 · Received January 5, 2017

    Report

    Report Number
    9710358-2016-00005
    Event Type
    Injury
    Date Received
    January 5, 2017
    Date of Event
    November 1, 2016
    Report Date
    December 16, 2016
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PRESENTATION AND TIME COURSE, IT IS POSSIBLY SIRT RELATED THOUGH STRICTLY SPEAKING NOT REILD BECAUSE BILIRUBIN IS NOT HIGHER THAN 3MG/DL AND THE ONSET IS MUCH LONGER THAN 2 MONTHS POST IMPLANTATION. THE ASCITES DOESN'T SEEM TO BE DUE TO LIVER PROGRESSION THOUGH THE RADIOLOGIST DID NOTE IN (B)(6) 2016 THAT THERE WAS INCREASED HYPODENSITIES IN THE LIVER, PROBABLY RADIATION EFFECTS OF THE LIVER. IF SIRT RELATED, I WE WOULD ALSO EXPECT TO SEE MORE RADIOLOGICAL FINDINGS RELATED TO PORTAL HYPERTENSION. IMPLANTED DEVICE UNABLE TO BE RETURNED.

    Description of Event or Problem · 1

    DOCTOR TREATED PATIENT WITH SIR-SPHERES MICROSPHERES IN (B)(6) 2016. IN (B)(6) PATIENT PRESENTS WITH CT RESULTS CHANGES TO THE LIVER, ASCITES AND ELEVATED BILIRUBIN. BASED ON LIVER ANATOMY CHANGES AND LAB VALUE CHANGES, DOCTOR SUSPECTED RADIATION INDUCED LIVER DISEASE, POSSIBLY DUE TO SELECTIVE INTERNAL RADIATION THERAPY (SIRT) WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10804 SIR-SPHERES MICROSPHERES YTTRIUM-90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001 KC031VO2

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention