BEUDAMED
    FDA Adverse Event Death Summary report: N

    IODINE (I-125) SEEDS

    MDR report key: 4184043 · Received October 16, 2014

    Report

    Report Number
    2915056-2014-00012
    Event Type
    Death
    Date Received
    October 16, 2014
    Report Date
    September 19, 2014
    Manufacturer
    GE HEALRTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K914281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SOURCE OF REPORT (LITERATURE): SEQUENCE NO. 1. AUTHOR: MD, PHD KOHICHI TAKADA, HIROTO HORIGUCHI, YUSUKE KAMIHARA, SOUSHI IBATA, SATOSHI IYAMA, TSUTOMU SATO, TSUYOSHI HAYASHI, KOJI MIYANISHI, YASUSHI SATO, RISHU TAKIMOTO, MASAYOSHI KOBUNE, KO KOBAYASHI, YASUO HIRAYAMA, NAOYA MASUMORI, TADASHI HASEGAWA, JUNJI KATO. JOURNAL TITLE: CASE REPORTS IN ONCOLOGY. YEAR: 2014. EDITION: 7 (2). PAGE NUMBER: FROM 565 TO 570. ARTICLE TITLE: RADIATION-INDUCED LEIOMYOSARCOMA OF THE PROSTATE AFTER BRACHYTHERAPY FOR PROSTATIC ADENOCARCINOMA.

    Description of Event or Problem · 1

    REPORT # 2915056-2014-00012 IS A LITERATURE REPORT FROM (B)(6) THAT INVOLVES A (B)(6) MALE WHO EXPERIENCED RADIATION-INDUCED LEIOMYOSARCOMA AFTER ADMINISTRATION OF IODINE (I-125) SEEDS FOR A PERMANENT BRACHYTHERAPY FOR A LOCALIZED PROSTATE CANCER. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT PRESENTED WITH DYSURIA AND GROSS HEMATURIA. HE WAS DIAGNOSED 6 YEARS AGO WITH LOCALIZED PROSTATE CANCER WITH A GLEASON SCORE OF 6. ON AN UNKNOWN DATE, THE PATIENT RECEIVED AN ADMINISTRATION OF PLANNED DOSE OF 145 GRAY (KY) OF IODINE (I-125) FOR THE PROCEDURE. SERUM PROSTATE-SPECIFIC ANTIGEN LEVEL WAS 9.5 NG/ML BEFORE TREATMENT, BUT WAS NORMAL AFTER BRACHY-THERAPY. URETHROSCOPY SHOWED STENOSIS BY A TUMOR AT THE PROSTATE. TRANSURETHRAL PROSTATECTOMY REVEALED THAT THE TUMOR WAS COMPRISED OF SMOOTH MUSCLE WITH SPINDLE CELLS THAT HAD CIGAR-SHAPED NUCLEI WITH PROMINENT CELLULAR ATYPIA, AND PROLIFERATED CELLS FORMING FASCICLES IN A STORIFORM PATTERN. IMMUNOHISTOCHEMICAL STAINING WAS POSITIVE FOR ALPHA-SMOOTH MUSCLE ACTIN (SMA) AND VIMENTIN, AND NEGATIVE FOR DESMIN, CD34, ESTROGEN RECEPTOR, AND PROGESTERONE RECEPTOR. BASED ON THESE FINDINGS, THE DIAGNOSIS WAS LEIOMYOSARCOMA OF THE PROSTATE. COMPUTED TOMOGRAPHY SHOWED THAT THE PROSTATIC TUMOR WAS OVER 5CM WITH A HIGH DENSITY OF METALLIC SEEDS, AND HAD INVADED DIRECTLY TO THE INFERIOR BLADDER WALL. THERE WAS NO METALLIC SEEDS, AND HAD INVADED DIRECTLY TO THE INFERIOR BLADDER WALL. THERE WAS NO METASTATIC LESION. POSITRON EMISSION TOMOGRAPHY SHOWED THAT THE ABNORMAL INCREASED UPTAKE WAS CONSISTENT WITH PROSTATIC TUMOR. DISTANT METASTASIS WAS NOT FOUND. HE WAS TREATED WITH THREE CYCLES OF NEOADJUVANT CHEMOTHERAPY (CTX) THAT CONSISTED OF DOXORUBICIN AND IFOSFAMIDE (AI) (DOXORUBICIN 30 MG/M2 ON DAYS 1-2, IFOSFAMIDE 2,000 MG/M2 ON DAYS 1-5, EVERY 21 DAYS), AND THEN A PROSTATOCYSTOTOMY WAS PERFORMED WITH INTRAPELVIC LYMPHADENECTOMY. PATHOLOGICAL FINDINGS REVEALED THAT THE SPINDLE-SHAPED TUMOR CELLS FORMED FASCICLES WITH STRONGLY ATYPICAL CLUBBED NUCLEI AND ACIDOPHILIC CYTOPLASM. THERE WERE LARGE POLYMORPHIC TUMOR CELLS WITH MANY MITOSES (OVER 20/10 HIGH POWER FIELDS) AND NECROSIS. THE PROPORTION OF NECROTIC TUMOR CELLS BY NEOADJUVANT CTX WAS ABOUT 50 PERCENT. THE TUMOR EXTENDED FROM THE PROSTATE AND INFILTRATED THE BLADDER WALL AND SEROA WITH LYMPHATIC AND VENOUS INVASION. THE SURGICAL MARGIN WAS NEGATIVE, AND NO RESIDUAL PROSTATIC ADENOCARCINOMA WAS OBSERVED. NOTABLY, NON-TUMOR PROSTATE CELLS HAD ENLARGED AS WELL AS ATYPICAL NUCLEI DUE TO RTX. IMMUNOHISTOCHEMISTRY SHOWED THAT TUMOR CELLS WERE POSITIVE FOR SMA, VIMENTIN, MUSCLE SPECIFIC ACTIN (HHF35), AND DESMIN AND FOCALLY POSITIVE FOR CYTOKERATIN AE1/AE3, AND NEGATIVE FOR S-100, CD117, EPITHELIAL MEMBRANE ANTIGEN, AND CD34. THE KI-67 LABELING INDEX WAS 60 PERCENT. INTERESTINGLY, IMMUNOHISTOCHEMICAL STUDIES SHOWED OVEREXPRESSION IN THE NUCLEI OF LEIOMYOSARCOMA CELLS. SUBSEQUENTLY, ADJUVANT CTX WAS OFFERED TO THE PATIENT BECAUSE OF A HIGH POSSIBILITY OF RECURRENCE, BUT HE CHOSE A FOLLOW-UP WITHOUT CTX. LOCAL RECURRENCE AND LUNG METASTASIS WERE DETECTED BY COMPUTED TOMOGRAPHY THREE MONTHS AFTER THE SURGERY. HE WAS TREATED AGAIN WITH AI. HOWEVER, CTX WAS NOT EFFECTIVE AND HE DIED SIX MONTHS AFTER THE OPERATION. THE PATIENT DIED ON AN UNKNOWN DATE. NO INFORMATION ON CAUSE OF DEATH OR AUTOPSY. TAKADA K, HORIGUCHI H, KAMIHARA Y, ET AL. RADIATION-INDUCED LEIOMYOSARCOMA OF THE PROSTATE AFTER BRACHYTHERAPY FOR PROSTATIC ADENOCARCINOMA. CASE REPORTS IN ONCOLOGY. AUGUST 16, 2014; 7(2): 565-570.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656682 IODINE (I-125) SEEDS RADIONUCLIDE BRACHYTHERAPY SOURCE KXK GE HEALRTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death