Boston scientific corporation became aware of the following event through the article, "outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature", by walayat, s., et al.Per the literature, a retrospective reviewed was performed to all patient who underwent colonic self-expanding metal stent placement from august 2004 through august 2022 at university of wisconsin.There were sixty-three patients over the age of 18 who underwent colonic stent placement.Fifty-five cases were for malignant indication, and eight were for benign conditions.The benign strictures included diverticular disease stricturing (n = 4), fistula closure (n = 2), extrinsic fibroid compression (n = 1), and ischemic stricture (n = 1).Forty-three of the malignant cases were due to intrinsic obstruction from primary or recurrent colon cancer; 12 were from extrinsic compression.Fifty-four strictures occurred on the left side, 3 occurred on the right and the rest in transverse colon.According to the literature, a case of a 78-year-old, female, with extrinsic compression at the sigmoid colon, was successfully implanted with a wallflex colonic stent.However, post stent placement, the stent had migrated, and the patient's bowel was perforated.This patient recently had a pulseless electrical activity (pea) arrest and was not a surgical candidate.
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Block b3: the exact date of event was not reported.The article published date is used for the estimated date of event.Block d4, h4: the literature article did not provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source: walayat, s., et al."outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature".World j gastrointest endosc 2023; 15(4): 309-318.Doi: 10.4253/wjge.V15.I4.309.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1006 captures the reportable patient complication of bowel perforation.
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