MAUDE brand profile
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE SYSTEM SAPIEN 3 26MM HEART VALVE WITH
MAUDE brand safety profile
Key facts
| Brand name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE SYSTEM SAPIEN 3 26MM HEART VALVE WITH |
|---|
At a glance
- 1–9 MAUDE reports
- 1–9 Death reports
- 1–9 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- Failure to Advance, Material Deformation, Cardiopulmonary Arrest, Extravasation, Abdominal Distention, Rupture, Pericardial Effusion, Death 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