BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IODINE (I-125) SEEDS

    MDR report key: 5985840 · Received September 28, 2016

    Report

    Report Number
    2915056-2016-00017
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K914281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    THIS REPORT IS A LITERATURE REPORT FROM JAPAN CONCERNING IODINE-125 (I-125) SEED MIGRATION WITHOUT ASSOCIATED ADVERSE EVENT (AE). THIS REPORT INVOLVES A (B)(6) MALE (1 OF 6 PATIENTS) IMPLANTED WITH 60 I-125 FREE SEEDS (ONCOSEED) FOR THE TREATMENT OF STAGE T1-T2 PROSTATE CANCER. CONCURRENT MEDICAL CONDITIONS/PAST MEDICAL HISTORY INCLUDED STAGE T1-T2 PROSTATE CANCER. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A TRANS PERINEAL INTERSTITIAL PROSTATE BRACHYTHERAPY TREATMENT OF STAGE T1-T2 PROSTATE CANCER WITH ONCOSEED AT A TOTAL DOSE RANGING FROM 110 TO 145 GY; LOT NUMBER WAS NOT PROVIDED. ONE YEAR AFTER BRACHYTHERAPY, CT ANGIOGRAPHY REVEALED A SEED LODGED IN THE RIGHT VENTRICULAR WALL. TREATMENT DETAILS WERE NOT PROVIDED. THERE WAS NO ASSOCIATED ADVERSE EVENT (AE). THE OUTCOME HAD NOT RESOLVED. ARTICLE SUMMARY: SEED MIGRATION IS A WELL-RECOGNIZED EVENT THAT OCCURS AFTER TRANS PERINEAL INTERSTITIAL PROSTATE BRACHYTHERAPY, AND IT IS OBSERVED MORE OFTEN WITH LOOSE SEEDS THAN WITH LINKED SEEDS. IT IS WELL KNOWN THAT THE MOST FREQUENT SITE OF SEED MIGRATION IS THE CHEST. SEED MIGRATION CAN RESULT IN A DECREASED DOSE BEING ADMINISTERED TO THE PROSTATE AND HAS SERIOUS EFFECTS ON VARIOUS ORGANS, SUCH AS THE HEART. IT IS ALSO ASSOCIATED WITH THE DEVELOPMENT OF SECONDARY MALIGNANCIES AND INFLAMMATION. THE STUDY WAS CONDUCTED TO EVALUATE THE INCIDENCE AND PREDICTORS OF SEED MIGRATION AFTER TRANS PERINEAL INTERSTITIAL PROSTATE BRACHYTHERAPY USING I-125 FREE SEEDS. FROM MAR-2007 TO MAR-2011, 121 PATIENTS WITH STAGE T1-T2 PROSTATE CANCER UNDERWENT TRANS PERINEAL INTERSTITIAL PROSTATE BRACHYTHERAPY ALONE, OR IN COMBINATION WITH HORMONAL THERAPY OR EXTERNAL BEAM RADIOTHERAPY. ALL PATIENTS RECEIVED ONCOSEED. PRE-PLANNING WAS PERFORMED 3 WEEKS PRIOR TO IMPLANTATION, AND THE IMPLANTS WERE INSERTED USING THE STANDARD PARALLEL NEEDLE INSERTION TECHNIQUE. ALL PATIENTS UNDERWENT A SERIES OF RADIOGRAPHS [CHEST RADIOGRAPHY, KIDNEY-URETER-BLADDER (KUB) RADIOGRAPHY, AND A CT SCAN] TO ASSESS WHETHER SEED MIGRATION HAD OCCURRED ON POSTOPERATIVE DAYS 1 AND 30, AND AT 12 MONTHS. RESULTS: SEED MIGRATION OCCURRED IN 31 (25.6%) OF 121 PATIENTS. IN 16 (51.6%) OF THE 31 PATIENTS, ONLY A SINGLE SEED MIGRATED. IN THE REMAINING 15 (48.4%) PATIENTS, TWO TO FIVE SEEDS MIGRATED. A TOTAL OF 51 OF 7,883 (0.65%) IMPLANTED SEEDS MIGRATED. MIGRATION WAS DETECTED ON POSTOPERATIVE DAY 1 IN 16 PATIENTS, DAY 30 IN 13 PATIENTS AND AT 12 MONTHS IN 4 PATIENTS (MIGRATION OCCURRED AT DIFFERENT TIMES IN 2 PATIENTS). THE MIGRATED SEEDS WERE FOUND IN THE LUNGS, PELVIS, HEART, MEDIASTINUM, KIDNEY, INGUINAL CANAL, LIVER, AND SACRUM. THE NUMBER OF NEEDLES WAS A STATISTICALLY SIGNIFICANT FACTOR IN SEED MIGRATION. THERE WAS NO SIGNIFICANT DIFFERENCE IN POST-PLANNING DOSE DELIVERED TO THE PROSTATE BETWEEN THE PATIENTS THAT DISPLAYED SEED MIGRATION AND THOSE THAT DID NOT. CONCLUSION: THE AUTHORS REPORTED THAT SEED MIGRATION OCCURRED IN 25.6% OF PATIENTS, AND IT WAS DETECTED WITHIN 1 MONTH OF THE INSERTION PROCEDURE IN MANY CASES (88% OF PATIENTS). THE NUMBER OF MIGRATED SEEDS RANGED FROM ONE TO FIVE (MEAN 1.6). SEEDS THAT BECOME LODGED IN THE PELVIS ON DAY 1 MIGHT RE-MIGRATE TO OTHER ORGANS. NO DIFFERENCE WAS NOTED IN THE QUALITY OF DOSIMETRY. ACCORDING TO THE AUTHORS, ALTHOUGH FOLLOW-UP MAY HAVE BEEN INADEQUATE TO DETERMINE WHETHER TOXICITY WILL RESULT IN VESSELS SECONDARY TO SEED EMBOLIZATION, NO ADVERSE EFFECTS ASSOCIATED WITH SEED MIGRATION WERE DETECTED. THE NUMBER OF NEEDLES WAS A SIGNIFICANT PREDICTOR OF SEED MIGRATION. THE AUTHORS CONCLUDED THAT THE RESULTS OF THIS STUDY SUGGEST THE NUMBER OF NEEDLES MIGHT BE USED TO PREDICT THE RISK OF SEED MIGRATION. MIYAZAWA, K, MATOBA, M, MINATO, H, ET AL. SEED MIGRATION AFTER TRANSPERINEAL INTERSTITIAL PROSTATE BRACHYTHERAPY WITH I-125 FREE SEEDS: ANALYSIS OF ITS INCIDENCE AND RISK FACTORS. JAPAN RADIOLOGICAL SOCIETY. (2012); 30: 635-641.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635710 IODINE (I-125) SEEDS RADIONUCLIDE BRACHYTHERAPY SOURCE KXK GE HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other