MAUDE manufacturer profile
EDWARDS · NPT
MAUDE profile for Aortic Valve, Prosthesis, Percutaneously Delivered
Key facts
| Manufacturer | EDWARDS |
|---|---|
| Manufacturer group | EDWARDS |
| Product code | NPT |
| Product code name | Aortic Valve, Prosthesis, Percutaneously Delivered |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Heart Block, Hemorrhage/Blood Loss/Bleeding, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Cardiac Tamponade, Device Dislodged or Dislocated, Mechanical Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1