Abstract
Purpose :
The Ahmed valve and Baerveldt implant are implemented broadly in glaucoma treatments and in reducing intraocular pressure (IOP). Retrospective analysis was performed to identify problems in device utility and clinical outcomes in these implants.
Methods :
The Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for adverse event reports for Ahmed/Baerveldt IOP-lowering devices from January of 2018 to June of 2022. Frequencies of all patient and device problems
associated with each adverse event report were recorded and then categorized into broader groupings. Graphs were created in Microsoft Excel.
Results :
332 adverse event reports from January of 2018 to June of 2022 were considered for analysis. Some of the most commonly reported device problems included retraction and resistance (47/332, 14.2%), erosion/malposition/dislocation (23/332, 6.9%), and occlusion/mechanical jams
(34/332, 10.2 %). Device twisting, breaking or fracturing (2/332, 0.6%) was the least likely reported event for disruption of device functionality. The most common patient problem in device implantation was the lack of a reduction in IOP or subsequent increase in IOP (54/332, 46.4%). Conversely, hypotony was recorded in 3.9 % (13/332) of the sample. Most other problems had less than 5% of occurrence in the 332 case sample: Macular edema (3/332, 0.9%), and conjunctival/scleral pathology (2/332, 0.6%) all had an incidence below 1% in patient
problems.
Conclusions :
While the glaucoma tube shunt data in MAUDE is likely underreported, our findings nevertheless suggest a diversity in the types of device and patient problems following Ahmed/Baerveldt device implantation. Efforts to improve reporting may shed more light on complications subsequent to device implantation and reduce short and long-term adverse events.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.