BEUDAMED
    FDA Adverse Event Summary report: N

    SIR-SPHERES

    MDR report key: 494210 · Received November 7, 2003

    Report

    Report Number
    9710358-2003-00005
    Date Received
    November 7, 2003
    Date of Event
    October 8, 2003
    Report Date
    November 7, 2003
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEE ALSO MDR 9710358-2003-00004. REPORT ON SECOND OF TWO PTS WITH MULTIFOCAL HCC SUPERIMPOSED UPON ADVANCED CIRRHOSIS WHO DIED APPROX FOUR MONTHS AFTER SELECTIVE INTERNAL RADIATION THERAPY (SIRT) WITH A PROVISIONAL (UNPROVED) DIAGNOSIS OF LIVER FAILURE SECONDARY TO RADIATION HEPATITIS. BOTH PTS WERE OF SIMILAR AGE AND HAD SIMILAR PATHOLOGIES AND CO-MORBIDITIES. WHEN ADVERSE OUTCOMES BECAME APPARENT, ADMINISTERED DOSES WERE CHECKED - NO EVIDENCE COULD BE FOUND OF INCORRECT DOSAGE OR TECHICAL PROBLEMS. CLINICAL EVENTS IN BOTH CASES WERE SIMILAR. APPROX ONE MONTH AFTER THE PROCEDURE, LIVER FUNCTION TESTS SHOWED PROGRESSIVE DETERIORATION AND THE PTS BECAME JAUNDICED AND EVENTUALLY DEVELOPED ASCITES. TREATABLE CAUSES FOR LIVER FAILURE WERE EXCLUDED. SLOW PROGRESSIVE LIVER FAILURE OCCURRED, WITH DEATH IN EACH CASE APPROX FOUR MONTHS AFTER IMPLANTATION OF THE RADIOACTIVE MICRO-PARTCILES. THERE WAS NO DOSE REDUCTION BECAUSE OF CIRRHOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE NAW SIRTEX MEDICAL LIMITED SIR-Y001 35543

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death