Cardiovasc Revasc Med. 2026 Jun 4:S1553-8389(26)00240-X. doi: 10.1016/j.carrev.2026.06.004. Online ahead of print.
ABSTRACT
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.
PMID:42250996 | DOI:10.1016/j.carrev.2026.06.004