MAUDE brand profile
EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
MAUDE brand safety profile
Key facts
| Brand name | EDWARDS SAPIEN 3 ULTRA RESILIA 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
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Heart Block, Insufficient Information, Perivalvular Leak, Stroke/CVA, No Clinical Signs, Symptoms or Conditions, Appropriate Term / Code Not 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