Real-world adverse events and device failure modes of the sentinel cerebral protection system: An analysis of the FDA MAUDE database 2022 to 2026.

BACKGROUND

Stroke remains a significant complication after transcatheter aortic valve replacement (TAVR), and embolic debris generated during the procedure is a major contributor. The Sentinel Cerebral Protection System is designed to reduce periprocedural stroke and stroke-related complications, but real-world data on device-related complications remain limited.

METHODS

We performed a retrospective descriptive analysis of post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database (September 2022-January 2026) to assess Sentinel-related adverse events, including deaths, injuries, and device malfunctions. Reports were categorized by event type, and findings were summarized as counts and percentages.

RESULTS

A total of 340 reports were included. Malfunctions were most frequent (77.9%), followed by injuries (20.6%) and deaths (1.5%). Stroke and associated cerebrovascular events accounted for 48 of patient-related adverse events. Common device issues included difficulty in removal in 147 cases, breakage in 64 cases, and positioning problems in 57 cases. Rare complications such as detachment, contamination, and mechanical failure were also noted.

CONCLUSIONS

This MAUDE database analysis found that reported Sentinel-related events were predominantly technical in nature, although clinically important adverse events were also identified. These findings provide real-world insights into device performance, highlight areas for procedural and design improvement, and underscore the importance of ongoing post-market surveillance.