BEUDAMED
    FDA Adverse Event Death Summary report: N

    IODINE (I-125) SEEDS

    MDR report key: 1080826 · Received July 16, 2008

    Report

    Report Number
    2915056-2008-00003
    Event Type
    Death
    Date Received
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    A MALE PT RECEIVED AN IMPLANT OF I-125 SEED IMPREGNATED VICRYL MESH FOR LOCAL CONTROL OF NON-SMALL CELL LUNG CANCER AFTER SUB-LOBAR RESECTION. THE IMPLANTS CONSISTED OF I-125 SEEDS SEWN INTO A NOMOGRAPHICALLY GUIDED GEOMETRIC ARRAY AND THE AREA OF THE IMPLANT THAT CONTACTED THE AORTA WAS GREATER THAN 50%. THE MESH DOSE DELIVERED TO THE PRESCRIPTION POINT WAS 114 GY (RANGE, 85-120). SERIAL POSTOPERATIVE COMPUTED TOMOGRAPHIC STUDIES REVEALED NO SEED MIGRATION AND ONLY LOCALIZED PARENCHYMAL PULMONARY FIBROSIS IN THE IMMEDIATE VICINITY OF THE IMPLANT. APPROXIMATELY 22 MONTHS AFTER THE IMPLANT, THE PT SUFFERED AN ACUTE AND FATAL HEMORRHAGE FROM SUSPECTED AORTIC RUPTURE ASSOCIATED WITH THE TREATMENT. CAREFUL EXAMINATION OF THIS CASE REVEALED THAT THIS PT RECEIVED POSTOPERATIVE MEDIASTINAL IRRADIATION THAT DELIVERED AN ADDITIONAL 4500 CGY AT 180 CGY PER FRACTION, WHICH WAS COMPLETED 3 MONTHS POSTOPERATIVELY. ANALYSIS OF THE ORTHOGONAL RADIOGRAPHIC FILMS OF THIS PARTICULAR CASE REVEALED THAT THE EXTERNAL BEAM PORTALS MARGINALLY OVERLAPPED THE SIGNIFICANT IMPLANT VOLUME. TROMBETTA M, COLONIAS A, MAKISHI D, KEENAN R, WERTS ED, LANDRENEAU R, PARDA D. TOLERANCE OF THE AORTA USING INTRAOPERATIVE IODINE-125 INTERSTITIAL BRACHYTHERAPY IN CANCER OF THE BRACHYTHERAPY (2008) 7; 50-54.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IODINE (I-125) SEEDS BRACHYTHERAPY IMPLANT KXK GE HEALTHCARE 6711 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death