CRT-711 Publicly Reported Adverse Events with the Edwards SAPIEN Valve - Trends and Event Classification in the FDA MAUDE Database

Abstract

Background: The frequency and significance of adverse events (AE) reported with transcatheter aortic valve replacement (TAVR) using Edwards SAPIEN THV in the voluntary, publicly available MAUDE database has not been characterized. Methods: The FDA MAUDE Database was queried for all reported events relating to Edwards SAPIEN TAVR through Oct. 2013. Data was reported on a quarterly basis using the MAUDE classification system. AE reports from 10/2011 through 4/2012 were categorized based on the Valve Academic Research Consortium (VARC) classification system. Results: 1222 total AE reports were found (MAUDE categories: death n = 234, injury n = 921, malfunction n = 67) with a significant increase over the first 5 analyzed quarters with stabilization in the final 3 quarters (fig 1). Of the 103 consecutive AEs analyzed, 69 were classifiable by VARC and 34 were not (table 1). Conclusion: Despite the limitations of this voluntary database, AE reports have increased since FDA approval of the Edwards SAPIEN THV, but have leveled off in 2013. The utility of the database to assess real-world AEs could be improved by the routine use of an accepted AE classification system(Figure Presented).