Trends in adverse events reported with the use of Xen gel stents

Abstract

Purpose : Xen gel stents are used in the management of primary or secondary open angle glaucoma that is refractory to medical therapy/surgical treatment. We performed a retrospective analysis to explore commonly reported patient and device complications associated with Xen gel stents.

Methods : The Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for medical device reports associated with the Xen gel shunts reported from January 2018 to July 2022. Patient and device problems were then compiled and categorized according to commonly represented types of problems. Analysis was carried out in Microsoft Excel.

Results : A total of 1221 cases were included for analysis on Xen gel stent associated patient and device problems. The most common reported device problem identified was device occlusion and/or mechanical jam, representing 17.4% of the cases; this was followed closely by material or tissue erosion and mispositioning of the device, representing 16% of the cases. The most common patient problem reported was no change in intraocular pressure (IOP)/increased IOP (including delay in IOP reduction), representing 26.5% of the cases. Infection/endophthalmitis as well as conjunctival/scleral pathologies were both observed in approximately 10% of cases. Suprachoroidal hemorrhaging was recorded in 5.3% of cases.

Conclusions : Our MAUDE database findings suggest a broad array of patient-related complications in addition to device-based issues reported with the Xen gel stents. This data suggests a need for thorough follow-up after installation of the Xen gel stent to mitigate deleterious long-term effects of patient and device problems that may arise.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.