User experience with Xen shows device exposure as most common adverse event
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Complications seen in practice after a device’s approval may differ from those seen in trials or reported in literature.
For Allergan’s Xen gel stent, the most common adverse events reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database between December 2016 and December 2019 were device exposure and device malposition, according to a poster presented at the virtual Women in Ophthalmology Summer Symposium.
“We identified 1,083 adverse events among 615 reports from December 22, 2016, to December 30, 2019,” Sarah H. Van Tassel, MD, poster coauthor told Healio/OSN. “Exposure of the device with erosion through the conjunctiva [108 cases] and device malposition were most commonly reported. Of 89 mispositioned devices, 23 were described as having been explanted.”
Van Tassel and colleagues queried the MAUDE database to compile reported adverse events associated with the gel stent since its approval in 2016. The study aimed to catalogue the complications as microinvasive glaucoma surgery continues to grow in popularity.
Of the reports, 186 were deemed non-clinically significant or had insufficient narrative. Of the remaining reports, elevated IOP was reported in 79 cases, and hypotony was reported in 38.
Other adverse events included device occlusion, device lost in the eye and device touching the iris or cornea. Bleb needling was reported in 68 cases, and infection, identified as endophthalmitis/hypopyon or blebitis, was reported in 56 cases. Choroidal hemorrhage, choroidal detachment, choroidal effusion or ciliary body effusion, and hyphema were also reported.
“Ophthalmologists should be aware of the range of potential complications so that appropriate training and preparation can take place and so that patients can be educated about potential risks,” the authors said.
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Yuan, et al. Adverse events associated with the Xen gel stent reported to the FDA. Presented at: Women in Ophthalmology Summer Symposium; Aug. 21-23, 2020 (virtual meeting).
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