BEUDAMED
    FDA Adverse Event Death Summary report: N

    IODINE (I-125 SEEDS)

    MDR report key: 4245044 · Received November 6, 2014

    Report

    Report Number
    2915056-2014-00016
    Event Type
    Death
    Date Received
    November 6, 2014
    Report Date
    October 14, 2014
    Product Code
    KXK
    PMA / PMN Number
    K914281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOURCE OF REPORT (LITERATURE): AUTHOR: ENOKIDA HIDEKI. JOURNAL TITLE: THE 79TH ANNUAL MEETING OF THE EASTERN SECTION OF JAPANESE UROLOGICAL ASSOCIATION. YEAR: 2014. ARTICLE TITLE: REPORT OF TWO CASES DIED OF PROGRESSIVE SECONDARY CANCER AFTER PROSTATE BRACHYTHERAPY. NO INFORMATION IS GIVEN REGARDING THE ADDITION OF EXTERNAL BEAM RADIOTHERAPY TO BRACHYTHERAPY. THE FORMER HAS BEEN ASSOCIATED WITH SECONDARY BLADDER CANCER. HOWEVER A RECENT REVIEW BY MURRAY ET AL STATED "THE INCREASED RISK OF BLADDER CANCER FREQUENTLY APPEARS TO BEGIN WITHIN 5 YEARS OF FOLLOW-UP INT HE ABOVE STUDIES AND SO RADIATION IS NOT THE LIKELY CAUSE OF THESE EARLY BLADDER TUMORS. SURVEILLANCE BIAS, AS A RESULT OF REGULAR ONCOLOGICAL OR UROLOGICAL FOLLOW-UP MAY PLAY A PART IN THIS, WHILE THE IMPACT OF SMOKING MAY ALSO BE INVOLVED IN EARLY (I.E. LESS THAN 5 YEARS FROM RT) AND LATE (I.E. BEYOND 5 YEARS OF RT) BLADDER CANCER DEVELOPMENT. BEYOND 5 YEARS THE RISK OF BLADDER CANCER APPEARS TO INCREASE FURTHER, AND RADIATION MAY BE ATTRIBUTED TO THIS ALTHOUGH THE FACTORS MENTIONED ABOVE SHOULD ALSO BE CONSIDERED. BRACHYTHERAPY ALONE HAS NOT BEEN SHOWN TO INCREASE THE RISK SECONDARY OF BLADDER CANCER. IN A RECENT STUDY BY HAMILTON ET AL DE INCIDENCE BLADDER CANCER AFTER BRACHYTHERAPY ALONE WAS NOT INCREASED WHEN COMPARED WITH BLADDER CANCER SUBSEQUENT TO RADICAL PROSTATECTOMY. INCIDENCE OF SECOND PRIMARY BLADDER CANCER WAS LINKED TO SMOKING HISTORY AND AGE.

    Description of Event or Problem · 1

    REPORT #: 2915056-2014-00016 IS A LITERATURE REPORT FROM JAPAN THAT INVOLVES A 67 YEAR OLD MALE WHO EXPERIENCED SECONDARY UROTHELIAL UNDIFFERENTIATED CANCER WITH MULTIPLE BONE, LYMPH NODE, AND LUNG METASTASES AFTER ADMINISTRATION OF IODONE (I-125) SEEDS FOR BRACHYTHERAPY FOR THE INDICATION OF PROSTATE CANCER. CONCURRENT MEDICAL CONDITIONS/PAST MEDICAL HISTORY INCLUDED PROSTATE CANCER. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT RECEIVED AN IMPLANT ADMINISTRATION OF IODINE (I-125) SEEDS FOR THE PROCEDURE. THE PATIENT'S PSA WAS 4.85 NG/ML WITH PREOPERATIVE DIAGNOSIS TLCN0M0 (GS6), UNDERWENT BRACHYTHERAPY. THERE WAS GROSS HEMATURIA IN TWO YEARS AND NINE MONTHS AFTER BRACHYTHERAPY AND A PAPILLOA LIKE TUMOR AT THE PROSTATIC URETHRA. THE PATIENT WAS DIAGNOSED WITH UNDIFFERENTIATED UROTHELIAL CANCER IN TUR BIOPSY. BLOOD CEA AND NSE WERE ABNORMALLY HIGH AND RAPID RISE IN PSA WAS ALSO OBSERVED. TUMORS WERE TREATMENT-RESISTANT AND CAUSED THE MULTIPLE BONE, LYMPH NODE AND LUNG METASTASES AFTER TWO MONTHS. THE PATIENT DIED IN FOUR YEARS AND ONE MONTH AFTER BRACHYTHERAPY. ENOKIDA HIDEKI ET AL; REPORT OF TWO CASES DIED OF PROGRESSIVE SECONDARY CANCER AFTER PROSTATE BRACHYTHERAPY. THE 79TH ANNUAL MEETING OF THE EASTERN SECTION OF JAAPNESE UROLOGICAL ASSOCIATION OCTOBER 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714253 IODINE (I-125 SEEDS) IODINE (I-125 SEEDS) KXK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death