Analysis of reported adverse events with esophageal dilation devices: a 10-year FDA manufacturer and user facility device experience database study

Esophageal dilation is a cornerstone therapeutic intervention in managing esophageal narrowing, using various types of dilation devices. While highly effective, it carries risks, including patient-related adverse events (PRAE) and device-related failures (DRF). Analysis of these complications is imperative for decision-making with the goal of enhancing procedural safety. Reports from the Manufacturer and User Facility Device Experience (MAUDE) database from January 2014 to June 2024 were analyzed. Although circulation numbers are unknown, event occurrence per device was compared using weighted averages of events and Poisson regression. A total of 1418 reports were identified, yielding 117 PRAE and 1845 DRF. The overall weighted average of PRAE was 0.07 (95% CI: 0.03, 0.11) per report, while DRF were 1.24 (95% CI: 1.13-1.36) per report. The most common PRAE was perforation (n = 32; 27%), with the most reports attributed to Rigiflex Pneumatic II (n = 13) and Savary-Giliard/American (n = 9). The most common DRFs pertained to material integrity issues which occur at relative rates 2.4 to 3.9 times higher than other device-related complications. About 117 PRAE reports were identified in the entire cohort. After excluding pneumatic dilation cases, it was determined that 70% (n = 71) of all PRAEs co-occurred with a material integrity issue. MAUDE analysis suggests variability in safety profiles across esophageal dilators. Perforation is the most reported PRAE across esophageal dilation procedures in general and may be linked to the co-occurrence of material integrity issues and aberrant guidewires in certain wire-guided polyvinyl dilators. To reduce PRAE occurrences, we encourage operators to recognize these patterns and their potential impact on adverse patient outcomes.