Current eye research · 2026
Complications and Safety Profile of XEN® Gel Stent in Glaucoma: A Five-Year MAUDE Database Analysis.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ghazou Alina, Hawas Yousef, Gerges Martin W, Awad Aya, Alkhawaldeh Ibraheem M, Marouf Mohamed, Alqudah Asem A
Аннотация
PURPOSE: To analyze adverse events associated with the XEN® Gel Stent using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS: 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.
RESULTS: 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%).
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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%).
CONCLUSIONS: 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.