RAPIDSTRAND IODINE I125 SEEDS, IODINE (125 I) 7000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05 report with the FDA on 2013-11-20 for RAPIDSTRAND IODINE I125 SEEDS, IODINE (125 I) 7000 manufactured by Ge Healthcare.

Event Text Entries

[15812958] This is a literature report from (b)(6) that involves a (b)(6) male who experienced prostatic sarcoma 9 years after implantation of rapidstrand iodine i-125 seeds for the indication of prostate cancer. On an unreported date, the patient received an interstitial permanent brachytherapy implant of rapidstrand iodine i125 seeds for a planned dose of 145 gy for the treatment of organ-confined gleason 6 prostate cancer. Serum prostate specific antigen (psa) was less than 10 ng/ml. Psa nadir of less than 0. 1 ng/ml was achieved 38 months after treatment, and no urinary or digestive toxicity were observed. Nine years after brachytherapy treatment urinary symptoms characterized by dysuria, nocturia, tenesmus and perineal pain started to appear. Obstructive symptomatology rapidly evolved, despite treatment with alpha-blockers for six months, with substantial increase in nocturia and stranguria, as well as pelvic and lumbar pain, constipation and toxic syndrome. Digital rectal examination showed a large and heterogeneous prostate mass. Acute renal failure (creatinine of 393 micromol/l) was detected in the blood test and psa levels continued to be below the levels of detection. Abdominal computed tomography (ct) scan revealed bilateral grade iii ureteral ectasia due to a large prostate with irregular contours. Thorax ct-scan did not find lung dissemination. Transrectal ultrasound-guided biopsies and prostate transurethral resection were performed. High-grade prostate saroma with bladder extension was suspected and the patient underwent radical cystoprostatectomy with urinary derivation and extended pelvic lymphadenectomy. Gross pathological examination of the surgical specimen showed the prostate to be entirely replaced by grayish tumor tissue, which extended into the bladder wall, surrounded the seminal vesicles and invaded the perivesical fat and both terminal ureters. Metastatic peritoneal nodules an bilateral pelvic lymph nodes were found as well. On histological examination, the tumor tissue range from bland myxoid areas with a heavy inflammatory component to frandly malignant ones, made up of bundles of ovoid to spindle large atypical cells admixed with occasional lymphocytes and plasma cells. Mitoses ans vascular invasion were easily found, and there were multiple foci of necrosis. On immunohistochemistry, the tumor cells were positive for vimentin and, focally, for cytokeratin ae1/ae3, cd68, and cd31, and negative for a number of other cytokeratins, ema, muscle markers, cd21, cd23, cd30, cd34, cd117, s-100 protein, psa and alk-1. On the basis of these results, the tumor was classified as a high-grade spindle cell sarcoma with features of inflammatory myofibroblastic tumor. The patient had atorpid post-surgical evolution and died three months after surgery due to surgical complications and disease progression. Dominguez a, piulats j, suarez j, et al; "prostatic sarcoma after conservative treatment with brachytherapy for low-risk prostate cancer"; acta oncol; 2013; 52 (6): 1215-1216.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2915056-2013-00084
MDR Report Key3482367
Report Source01,03,05
Date Received2013-11-20
Date of Report2013-10-29
Date Mfgr Received2013-10-29
Date Added to Maude2013-11-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street101 CARNEGIE CENTER PHARMACOVIGILANCE DEPT
Manufacturer CityPRINCETON NJ 08540
Manufacturer CountryUS
Manufacturer Postal08540
Manufacturer Phone6095146000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAPIDSTRAND IODINE I125 SEEDS, IODINE (125 I)
Generic NameRADIONUCLIDE BRACHYTHERAPY SOURCE
Product CodeIWI
Date Received2013-11-20
Model Number7000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGE HEALTHCARE
Manufacturer AddressARLINGTON HEIGHTS IL 60004 US 60004


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Other 2013-11-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.