BEUDAMED
    FDA Adverse Event Summary report: N

    SIR-SPHERES

    MDR report key: 494214 · Received November 7, 2003

    Report

    Report Number
    9710358-2003-00004
    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 9710358-2003-00005. REPORT ON FIRST OF TWO PATIENTS WITH MULTIFOCAL HCC SUPERIMPOSED UPON ADVANCED CIRRHOSIS WHO DIED APPROXIMATELY FOUR MONTHS AFTER SELECTIVE INTERNAL RADIATION THERAPY (SIRT) WITH A PROVISIONAL (UNPROVED) DIAGNOSIS OF LIVER FAILURE SECONDARY TO RADIATION HEPATITIS. BOTH PATIENTS 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 TECHNICAL PROBLEMS. CLINICAL EVENTS IN BOTH CASES WERE SIMILAR. APPROXIMATELY ONE MONTH AFTER THE PROCEDURE, LIVER FUNCTION TESTS SHOWED PROGRESSIVE DETERIORATION AND THE PATIENTS BECAME JAUNDICED AND EVENTUALLY DEVELOPED ASCITES. TREATABLE CAUSES FOR LIVER FAILURE WERE EXCLUDED. SLOW PROGRESSIVE LIVER FAILURE OCURRED, WITH DEATH IN EACH CASE APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION OF THE RADIOACTIVE MICRO-PARTICLES. 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 68 YR Death