BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 1368827 · Received January 22, 2009

    Report

    Report Number
    9710358-2009-00001
    Event Type
    Death
    Date Received
    January 22, 2009
    Report Date
    January 20, 2009
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WAS POLYCHEMOTHERAPY RESISTANT AND TREATED AS SALVAGE THERAPY WHERE THERE IS USUALLY AN EXTREMELY NARROW WINDOW OF NORMAL LIVER. RAISED BILIRUBIN AT 4 WEEKS POST SIRT IS CONSISTENT WITH RADIATION HEPATITIS/RADIATION-INDUCED LIVER DISEASE. WE WILL FOLLOW UP FOR DISCUSSIONS TO REVIEW: DOSIMETRY IN POLYCHEMOTHERAPY-RESISTANT MCRC. MGMT OF RADIATION HEPATITIS/RADIATION INDUCED LIVER DISEASE BASED ON CURRENT LITERATURE. THERE IS NO EVIDENCE OF PRODUCT MALFUNCTION - THE BATCH MET ALL RELEASE CRITERIA. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    DEATH RELATED TO MUTI-ORGAN SYSTEM FAILURE COMPLICATING SEPSIS. ORIGINAL DIAGNOSIS, 2004, LIVER METASTASES. 2004, TREATMENTS INCLUDED: 5 FU, AVASTIN, ERBITUX, IRINOTECAN. ECOG 0. NO UNDERLYING LIVER DISEASE. BSA 1.92 SHUNT 6%. BASELINE LFT. TI BILI 1.5. ERBITUX DISCONTINUED 2 WEEKS PRIOR TO TREATMENT. SIR-SPHERES TREATMENT WHOLE LIVER TREATMENT DATE 2008. LIVER VOL 2178. PRESCRIBED ACT 1.9 GBQ. DELIVERED 1.9 GBQ. ERBITUX REINITIATED AFTER 2 WKS AT ONCOLOGIST. FAILURE TO RESPOND TO MEDICAL TREATMENT OF SEPSIS LED TO MULTIORGAN SYSTEM FAILURE AND DEATH FROM COMPLICATIONS OF SEPSIS ABOUT 3 MONTHS LATER. WHILE THE PATIENT'S RADIATION INDUCED, LIVER DISEASE APPEARED TO RESPOND TO STEROID THERAPY. IT IS FELT THAT THE STEROID THERAPY CONTRIBUTED TO THE PATIENT'S SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES MICROSPHERES YTTRIUM 90 RESIN MICROSPHERES KXK SIRTEX MEDICAL LIMITED Y001 115698-09 OR -09

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death