MAUDE brand profile
EVOLUT R TRANSCATHETER AORTIC VALVE
MAUDE brand safety profile
Key facts
| Brand name | EVOLUT R TRANSCATHETER AORTIC VALVE |
|---|
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems coded
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Perivalvular Leak, Non specific EKG/ECG Changes, Complete Heart Block, Device Dislodged or Dislocated, Insufficient Information, No Known Impact Or Consequence To Patient, Valvular Insufficiency/ Regurgitation 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