MAUDE manufacturer profile
EDWARD LIFESCIENCES · NPT
MAUDE profile for Aortic Valve, Prosthesis, Percutaneously Delivered
Key facts
| Manufacturer | EDWARD LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES |
| 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
- Adverse Event Without Identified Device or Use Problem, Difficult to Remove, Heart Block, Vascular Dissection, Insufficient Information, Migration or Expulsion of Device, Material Split, Cut or Torn, Inflation 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