Northwell Health, Lenox Hill Hospital New York, NY
Introduction: Esophageal stents are widely utilized for the treatment of benign and malignant obstructions. However, associated procedural complications are not well described. We aim to investigate post Food and Drug Administration (FDA) approval outcomes associated with esophageal stents.
Methods: We analyzed post-marketing surveillance data on esophageal stents from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from January 2015 to December 2021 to report device-related injuries and modes of failure. This database is an open-access platform that receives device reports from mandatory sources, including manufacturers and facilities, as well as, voluntary sources such as healthcare professionals, patients and consumers. These reports allow the FDA to monitor device performance and device-related safety concerns.
Results: During the study period, approximately 899 reported cases with 1312 device issues and 303 patient complications were examined. Reported cases included Ultraflex stent (n= 275, 30.6%), Wallflex stent (n= 210, 23.4%), Covered NITI-S stent (n= 144, 16.0%), and Evolution Partially Covered stent (n= 98, 10.9%). The most reported device issues were due to activation, position, or separation failure (n= 597, 45.5%), followed by migration or expulsion of device (n= 120, 9.1%), break (n= 96, 7.3%), difficulty to remove (n= 43, 3.3%), and material deformation (n= 41, 3.1%). A number of reports described an unclassified adverse event without specifying device or operator problem (n= 100, 7.6 %). The most reported patient adverse events were dysphagia or odynophagia (n= 29, 9,6%), followed by death (n= 24, 7.9%), hemorrhage (n= 22, 7.3%), obstruction or occlusion (n= 22, 7.3%), and perforation (n= 17, 5.6%).
Discussion: Our analysis of the FDA MAUDE database revealed a predominance of reported device complications related to activation, positioning, and separation difficulties. Dysphagia or odynophagia represented the most commonly reported patient complication. This database has notable limitations, including limited information on patient comorbidities, detailed endoscopy reports, an absence of operator experience and total volume of procedures performed in the United States. This study provides insight into the most commonly reported complications of esophageal stents that will help inform the risk/benefit conversation with patients and may lead to a more detailed approach on how to mitigate and manage complications.
