Complications and Safety Profile of XEN^® Gel Stent in Glaucoma: A Five-Year MAUDE Database Analysis

To analyze adverse events associated with the XEN^® Gel Stent using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

The FDA MAUDE database was queried for reports from January 1, 2020, to November 8, 2024, using the product code "KYF." Reports unrelated to the XEN^® Gel Stent were excluded. Data were analyzed for patient demographics, event types, and device-related complications. Descriptive statistics were used to outline the trends in device-related and patient-related issues.

A total of 1,816 reports were identified. After excluding 688 reports unrelated to the XEN^® Gel Stent, 338 reports that originated from the literature rather than primary MAUDE submissions, and 2 reports with insufficient information, 788 reports were included for analysis. The most frequently reported device-related issues included Difficult to insert (device sticking) (n = 217, 36.7%), Obstruction of flow (n = 78, 13.2%), device malposition (68, 11.5%). Common patient-related complications included increased intraocular pressure (IOP) (142, 21.8%) and eye injury (137, 21.0%), followed by erosion (77, 11.8%).

Over five years, the MAUDE database has revealed that the most common issues with the XEN^® Gel Stent involve device-related problems like resistance and blockage, as well as patient complications. While the data comes from voluntary reports and has its limitations, these real-world insights are valuable.