BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 8101634 · Received November 26, 2018

    Report

    Report Number
    9710358-2018-00005
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    January 1, 2018
    Report Date
    August 3, 2018
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR MCRC. THE PATIENT WAS TREATED IN A SEQUENTIAL LOBAR FASHION WITH SIR-SPHERES IN (B)(6). AT SOME POINT THE PATIENT DEVELOPED A COMPLICATION OF TREATMENT, GASTRIC ULCER. THE PATIENT HAS HAD MEDICAL INTERVENTION AND BEEN HOSPITALIZED TWICE. SURGICAL INTERVENTION (JTUBE) IS BEING CONSIDERED. THE PATIENT'S DAUGHTER REPORTED THIS EVENT. THE BELOW IS AN EMAIL FROM PATIENT'S DAUGHTER I AM AN ONCOLOGY NURSE AT (B)(6) AND HAVE READ MANY ARTICLES LOOKING FOR FURTHER DATA ON LONG TERM COMPLICATIONS WITHOUT MUCH RESOLUTION. I AM HOPING YOU MAY BE ABLE TO FORWARD MY EMAIL OR DIRECT ME TO SOMEONE THAT COULD PROVIDE FURTHER INFORMATION REGARDING SERIOUS COMPLICATIONS TO THE Y-90 TREATMENT. MY MOTHER HAD Y-90 TREATMENT FOR STAGE IV COLON CANCER WITH LIVER METS BACK IN (B)(6) AS THEY HAD TO TREAT EACH LOBE OF THE LIVER. THE Y-90 ENDED UP IN HER STOMACH AND SHE WAS HOSPITALIZED TWICE, HAS HAD FOUR DILATIONS AND HAS BEEN TREATED WITH A PHARMACY OF MEDICATION. SHE HAS SINCE LOST 40 POUNDS AND I HAVE TAKEN HER FOR TWO GI CONSULTATIONS TO SEE IF ANYONE COULD OFFER AN ADDITIONAL INFORMATION OR TREATMENT OPTIONS. WE HAVE LOOKED INTO J-TUBE OR TPN BUT HAVEN'T GOT TO THAT JUST YET, THERE WAS CONCERN OF PLACING A STENT WHICH WAS ANOTHER DISCUSSION. I AM GRASPING AT STRAWS TO FIND OUT IF ANYONE HAS PROVIDED ALTERNATIVE TREATMENT OPTIONS FOR THIS POTENTIAL COMPLICATION OR IF THERE IS FURTHER DATA ON LONG TERM AFFECTS FROM THIS COMPLICATION AS THIS HAS SEVERELY AFFECTED HER QUALITY OF LIFE AS WE BOTH KNOW IS LIMITED WITH HER DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940155 SIR-SPHERES MICROSPHERES YTTRIUM 90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization