MAUDE brand profile
EVOLUT PRO TRANSCATHETER AORTIC VALVE
MAUDE brand safety profile
Key facts
| Brand name | EVOLUT PRO 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, Non specific EKG/ECG Changes, Insufficient Information, Device Dislodged or Dislocated, Complete Heart Block, Perivalvular Leak, Patient Device Interaction Problem, 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