医学
不利影响
穿孔
上市后监督
食品药品监督管理局
腹痛
外科
支架
普通外科
内科学
医疗急救
冶金
材料科学
冲孔
作者
Daryl Ramai,Matthew DeLuca,Antonio Facciorusso,Andrew Ofosu,Mohit Girotra,James H. Tabibian,Eduardo Rodrigues‐Pinto,Douglas G. Adler,Monique T. Barakat
标识
DOI:10.1097/mcg.0000000000001632
摘要
Colonic stents are indicated for preoperative and palliative decompression of large bowel obstruction. We aim to investigate post Food and Drug Administration (FDA) approval outcomes associated with colonic stents.We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from January 2011 to December 2020.During the study period, 691 device issues and 742 patient complications were identified. The number of adverse events reported to the FDA mildly increased from 6.40% in 2011 to 7.4% in 2020. Most device complications were due to a positioning problem (n=201, 29%), followed by device break (n=60, 8.6%), delamination (n=41, 6.3%), and migration or expulsion device (n=38, 5.55%). A number of reports described an unclassified adverse event without specifying device or operator problem (n=141, 20.3%). The most reported patient adverse events were perforation (n=150, 20.1%), death (n=47, 6.3%), abdominal pain/discomfort (n=27, 3.6%), and peritonitis (n=24, 3.2%).Findings from the MAUDE database highlight rare but important patient and device complications which endoscopists and referring providers should be aware of before consideration for colonic stent placement.
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