MAUDE brand profile
EDWARDS TRANSCATHETER HEART VALVE
MAUDE brand safety profile
Key facts
| Brand name | EDWARDS TRANSCATHETER HEART VALVE |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Cardiac Tamponade, No Code Available, Perivalvular Leak, Mitral Valve Insufficiency/ Regurgitation, Insufficient Information, Aortic Valve Insufficiency/ Regurgitation, 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