MAUDE brand profile
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
MAUDE brand safety profile
Key facts
| Brand name | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE |
|---|
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 10–99 Malfunction reports
- 100–999 Problems coded
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Aortic Regurgitation, Perivalvular Leak, Malposition of Device, Degraded, Complete Heart Block, Calcified, No Code Available Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1