BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 1013812 · Received January 10, 2008

    Report

    Report Number
    9710358-2008-00001
    Event Type
    Death
    Date Received
    January 10, 2008
    Date of Event
    October 17, 2007
    Report Date
    January 9, 2007
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    PMA / PMN Number
    990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USE IS OFF-LABEL, HOWEVER WE EVALUATED THE PROCESSES INVOLVED. USER ADVISES THEY KNOW FROM EXPLORATORY SURGERY DONE 5/07 THAT THIS PT HAD MUCH MORE DISEASE WITHIN THE LIVER THAN SEEN ON RADIOGRAPHS. CALCULATED TOTAL ACTIVITY BY BSA METHOD (R+L LOBES) WAS 1.59 GBQ, GIVEN TOTAL ACTIVITY WAS 0.8 + 0.28 = 1.08 GBQ. SMALL LIVER SIZE WAS A FACTOR IN REDUCING DOSE. HOT SPOTS ON SPECT FROM MAA SCAN PRE TX CORRESPONDED TO THE AREA OF GREATEST TUMOR ON CT. WE BELIEVE FROM THE GIVEN DATA EVERYTHING WAS FINE REGARDING DOSE CALCULATION, WITH APPROPRIATE REDUCTION DUE TO (EXPECTED !) MINOR INVOLVEMENT OF THE LIVER ETC. WHAT POSSIBILITY HAPPENED WAS THAT IT WAS A "NON OPTIMAL" INDICATION DUE TO PROBABLY MICRO-METS THAT LED TO HIGHER COLLATERAL DAMAGE THAN COULD BE EXPECTED. WE ARE HOPING TO BE ABLE TO CHECK THE CORRELATION BETWEEN TCMAA SPECT (INDIVIDUAL TUMORS IDENTIFIABLE ?- PROBABLY NOT !?) AND CT/MRI SCANS. NO DOPPLER OR AUTOPSY WAS PERFORMED. THIS APPEARS TO BE AN UNUSUAL CASE AS ALL OF SOURCES SO FAR DO NOT THINK IT COULD BE RELATED TO THE LOW DOSES OF RADIATION (0.8 AND 0.28 GBQ), HOWEVER, WE ARE DRAWING A BLANK ON ALL OTHER CAUSES AT THIS TIME. IF ADD'L DATA COMES TO HAND, WE WILL PASS IT THROUGH.

    Description of Event or Problem · 1

    LIVER FAILURE FOLLOWING SIRT THERAPY. PT WITH BREAST CANCER WITH EXTENSIVE LIVER METS. 2006: BREAST CA W DISEASE IN L BREAST, L AXILLA, LIVER. IN 2007 R LOBE: 0.84 GBQ. ON THE FOLLOWING MONTH, L LOBE 0.28 GBQ. TX TO L LOBE WAS LIMITED BY STASIS. POST-PROCEDURE CLINICAL COURSE; SIGNS AND SYMPTOMS, PAIN, FATIGUE, ASCITES, ETC. RUQ PAIN, PROGRESSING TO MASSIVE ASCITES, JAUNDICE, ENCEPHALOPATHY. POST-PROCEDURE IMAGING FINDINGS CT ABD/PELVIS THE FOLLOWING MONTH: SEVER HEPATITIS. ASCENDING COLITIS SHOULD BE ASSESSED FOR C DIFF. ALTERNATIVELY, THIS MAY REFLECT PORTAL COLOPATHY. ANASARCA WITH INTERVAL DEVELOPMENT OF MARKED ASCITES AND PLEURAL EFFUSIONS. PROBABLE METASTASIS TO S1 VERTEBRAL BODY. RIGHT LOWER LOBE COLLAPSE. POST-PROCEDURE LABS SAME DAY: ALK PHOS 1145, AST 2787, ALT 2288, 1DH 3615, BLOOD AMMONIA 248, LACTIC ACID 6.3, PT 53.5 (ON NO ANTICOAGULANTS), ACETAMINOPHEN >10 NO LIVER BX PERFORMED, BLOOD, ASCETIC FLUID, URINE, STOOL, TRACHEAL SWABS ALL CULTURES NEGATIVE. ASCITES WAS TRANSUDATIVE, CYTOLOGY NEGATIVE FOR CANCER. HEP B E AG NEG. PLASMA HEP C VIRAL RNA, PCR, QUANTITATIVE DRAWN SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES MICROSPHERES Y90 MICROSPHERES KXK SIRTEX MEDICAL LIMITED Y001 113913-04

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death L LOBE 0.28 GBQ. TX TO L LOBE WAS LIMITED BY| STASIS| R LOBE: 0.84 GBQ.| BOTH LOBES TREATED