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Adverse events associated with the subconjunctival Ex-Press® Glaucoma Filtration Device: a ten-year review of the
Mohamed Marouf1, Arwa AbuYounis2, Alina Ghazou3
1Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Purpose:
To analyze adverse events related to the Ex-Press® Glaucoma Filtration Device reported in the FDA's MAUDE database over a 10-year period.
Study Design:
A retrospective case series.
Methods:
We retrospectively reviewed 533 unique adverse event reports submitted between January 1, 2015, and November 8, 2024. Data collected included patient demographics, reporter details, device model, event type (injury vs. malfunction), problem codes, and device availability for manufacturer evaluation. Descriptive statistics summarized patterns of device and patient problems.
Results:
The median patient age was 72 years (range 20-94), with sex reported in 2.3% of cases. The P-50 PL model accounted for 98% of reports, followed by the P-200 PL (2%). Devices were available for evaluation in 36.8% of cases, but only 19.3% were evaluated. Reports were 61% injuries and 39% malfunctions. A total of 440 device-related and 457 patient-related problems were identified. The most common device problems were displacement (31.4%) and flow obstruction (26.8%). Among patient problems, increased intraocular pressure (27.6%) and iris contact (22.3%) were most frequent. Injuries predominated in 2015-2016 (73.7%), shifting to malfunctions from 2020 to 2024 (76.9%).
Conclusions:
Adverse events involving the Ex-Press® device primarily include injuries and malfunctions, with device displacement and flow obstruction being most common. The observed shift likely reflects changes in device use and surveillance rather than true safety changes. Despite limitations of passive reporting, these findings offer valuable real-world insights that complement clinical trial data and highlight the utility of the FDA's MAUDE database as a tool for post-market surveillance. This approach can be replicated for other ophthalmic devices to enhance long-term safety monitoring and inform clinical decision-making.
Insights
Adverse events with the Ex-Press® Glaucoma Filtration Device include injuries and malfunctions, mainly device displacement and obstruction. Analysis of FDA MAUDE data reveals insights into post-market safety.
Area of Science:
- Ophthalmology
- Medical Device Safety
- Glaucoma Treatment
Background:
- The Ex-Press® Glaucoma Filtration Device is used to manage intraocular pressure in glaucoma patients.
- Post-market surveillance is crucial for understanding real-world device performance and safety.
- The U.S. Food and Drug Administration's MAUDE database collects reports of adverse events for medical devices.
Purpose of the Study:
- To analyze adverse events associated with the Ex-Press® Glaucoma Filtration Device.
- To examine trends in reported injuries and malfunctions over a 10-year period using FDA MAUDE data.
- To identify common device-related and patient-related problems.
Main Methods:
- Retrospective case series analysis of 533 unique adverse event reports from the FDA MAUDE database (January 1, 2015 – November 8, 2024).
- Data extraction included patient demographics, device model, event type (injury vs. malfunction), and problem codes.
- Descriptive statistics were used to summarize patterns of device and patient problems.
Main Results:
- The Ex-Press® P-50 PL model comprised 98% of reports.
- Common device problems included displacement (31.4%) and flow obstruction (26.8%).
- Frequent patient problems were increased intraocular pressure (27.6%) and iris contact (22.3%). A shift from injuries to malfunctions was observed over time.
Conclusions:
- Adverse events are primarily injuries and malfunctions, with displacement and obstruction being most common.
- The observed shift in event types may reflect changes in device use or surveillance, not necessarily safety.
- FDA MAUDE data provides valuable real-world insights for post-market surveillance of ophthalmic devices.
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