BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IODINE I125 SEEDS, IODINE (125 I)

    MDR report key: 868296 · Received June 20, 2007

    Report

    Report Number
    2915056-2007-00003
    Event Type
    Injury
    Date Received
    June 20, 2007
    Report Date
    June 20, 2007
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES

    Description of Event or Problem · 1

    A MALE PATIENT WITH A HISTORY OF SMOKING FOR 40 YEARS PRESENTED WITH A NONPRODUCTIVE COUGH. CHEST X-RAY REVEALED RIGHT HILAR FULLNESS. CT SCAN REVEALED AN 8 X 7 X 7.5 CM MEDIASTINAL MASS AT THE LEVEL OF THE CARINA, EXTENDING DOWNWARD. AND DISPLACING THE ESOPHAGUS POSTERIORLY. STAGING INVESTIGATIONS SHOWED NO EVIDENCE OF METASTATIC DISEASE. BIOPSY OF ONE PARATRACHEAL LYMPH NODE AT MEDIASTINOSCOPY GAVE A DIAGNOSIS OF TYPICAL CARCINOID TUMOR. HE UNDERWENT NEOADJUVANT RADIATION TO A DOSE OF 50 GY IN 25 FRACTIONS WITH CONCURRENT CISPLATINUM AND ETOPOSIDE. AT RESECTION, THE RESECTED SPECIMEN REVEALED AN 8 CM TYPICAL MEDIASTINAL CARCINOID WITH 2/10 MITOSES PER HIGH POWER FIELD. INTRAOPERATIVE FROZEN SECTION ANALYSIS REVEALED THE PRESENCE OF TUMOR CELLS AT THE ESOPHAGEAL MARGIN IN A 9 X 4 CM AREA, ELSEWHERE, THE TUMOR WAS ENCLOSED WITHIN A CAPSULE, WHICH SEEMED FULLY EXCISED. AT THE TIME OF TUMOR RESECTION, THE ESOPHAGEAL WALL WAS PARTIALLY RESECTED AT THE AREA OF ADHERENT TUMOR IN ATTEMPT TO PRODUCE NEGATIVE MARGINS; THE SUBCARINAL SPACE WAS EXTENSIVELY RESECTED. THE DECISION WAS MADE TO PLACE A PERMANENT BRACHYTHERAPY IMPLANT WITH THE INTENTION OF ORGAN PRESERVATION. CUSTOM PERMANENT IODINE (I-125) SEED IMPLANTS WERE PREPARED INTRAOPERATIVELY WITH VICRYL MESH (ETHICON) AND IODINE (I-125) SEEDS EMBEDDED IN VICRYL SUTURE (ONCURA). THE SEEDS WERE FIXED IN THE SUTURE AT 1 CM INTERVALS AND SEWED INTO THE VICRYL MESH IN A GEOMETRICALLY COHERENT PATTERN; A GRID WAS DRAWN WITH 1CM LANES TO PROVIDE A UNIFORM DOSE AT 5MM. THE COMPLETED IMPLANT WAS STITCHED IN A PLANAR FASHION DIRECTLY TO THE PARTIALLY RESECTED ESOPHAGEAL WALL AT THE AREA CLOSE TO TUMOR MARGIN. BECAUSE THE ESOPHAGUS HAD BEEN PARTIALLY RESECTED, AND HAD RECEIVED A RADIATION DOSE CLOSE TO KNOWN ORGAN TOLERANCE THE IMPLANT STRENGTH WAS DESIGNED TO GIVE A BOOST DOSE OF APPROXIMATELY 25 GY AT 0.5CM FROM THE IMPLANT PLANE SEEDS WITH A STRENGTH BETWEEN 0.007 MBQ (0.25 MCI) AND 0.008 MBQ (0.31 MCI) WERE USED. THREE HUNDRED DAYS AFTER IMPLANTATION, THE PATIENT DEVELOPED A BRONCHO-PLEURAL FISTULA AND AN ESOPHAGEAL STENT WAS PLACED. SIX MONTHS LATER, HE UNDERWENT FISTULA REPAIR BY SERRATUS ANTERIOR FLAP WITHOUT ESOPHAGECTOMY. THERE WAS NO EVIDENCE OF DISEASE RECURRENCE AT THIS TIME. ULTIMATELY, HE DIED DUE TO PNEUMONIA SEVERAL MONTHS AFTER FISTULA REPAIR, AND THERE WAS NO EVIDENCE OF LOCAL DISEASE PROGRESSION AT THE TIME OF DEATH. "SEVERE TOXICITY AFTER PERMANENT RADIOACTIVE SEED IMPLANTATION FOR MEDIASTINAL CARCINOID TUMORS". STEWART A ET AL, BRACHYTHERAPY (2007); 6:58-61.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IODINE I125 SEEDS, IODINE (125 I) UNK KXK GE HEALTHCARE NR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR