FDA Adverse Event Injury Summary report: N

IODINE I125 SEEDS, IODINE (125 I)

MDR report key: 868291 · Received June 20, 2007

Report

Report Number
2915056-2007-00002
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

Description of Event or Problem · 1

A MALE PATIENT PRESENTED WITH SHORTNESS OF BREATH AFTER RUNNING 5 MILES. COMPUTED TOMOGRAPHY (CT) SHOWED AN 8 X 7.8CM SUBCARINAL MASS COMPLETELY OBSTRUCTING THE LEFT LOWER LOBE BRONCHUS. CT-GUIDED NEEDLE BIOPSY REVEALED ATYPICAL CARCINOID. STAGING INVESTIGATIONS SHOWED NO EVIDENCE OF METASTATIC DISEASE. HE RECEIVED NEOADJUVANT RADIATION THERAPY TO A DOSE OF 54 GRAYS IN 30 FRACTIONS, WITH CONCURRENT CISPLATINUM, ETOPOSIDE AND DOCETAXEL CHEMOTHERAPY. AFTER CHEMOTHERAPY, MAGNETIC RESONANCE IMAGING (MRI) SHOWED A RESIDUAL MEDIASTINAL MASS DISPLACING THE ESOPHAGUS, AORTA, AND LUNG. AT RESECTION, THE SURGICAL SPECIMEN SHOWED A GRADE 2 ATYPICAL CARCINOID WITH 1/10 MITOSES PER HIGH-POWER FIELD; 9 OUT OF RESECTED 10 LYMPH NODES WERE POSITIVE FOR TUMOR. INTRAOPERATIVE FROZEN SECTION ANALYSIS SHOWED AN AREA 8 X 3CM WITH POSITIVE MARGINS (<1MM) AT THE ESOPHAGUS, OTHERWISE, THE TUMOR WAS FULLY RESECTED. 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) SEED EMBEDDED IN VICRYL SUTURE (ONCURA). THE SEEDS WERE FIXED IN THE SUTURE A T 1 CM INTERVALS AND SEWED INTO THE VICRYL MESH IN A GEOMETRICALLY COHERENT PATTERN; A GRID WAS DRAWN WITH 1 CM 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 HA D RECEIVED A RADIATION DOSE CLOSE TO KNOWN ORGAN TOLERANCE, THE IMPLANT STRENGTH WAS DESIGNED TO GIVE A BOOST DOSE OF APPROXIMATELY 25 GY AT 0.5 CM FROM THE IMPLANT PLANE SEEDS WITH A STRENGTH BETWEEN 0.007 MBQ (0.25 MCI) AND 0.008 MBQ (0.31 MCI) WERE USED. EIGHTY-THREE DAYS AFTER IMPLANTATION, THE PATIENT DEVELOPED AN ESOPHAGEAL-PLEURAL FISTULA. THE IMPLANT WAS REMOVED AND ESOPHAGECTOMY PERFORMED. ULTIMATELY, HE DIED DUE TO RECURRENT DISEASE AND THERE WAS NO EVIDENCE OF LOCAL DISEASE PROGRESSION AT 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) BRACHYTHERAPY IMPLANT KXK GE HEALTHCARE NR UNK

Patients

Seq Age Sex Outcome Treatment
1 34 YR