MAUDE manufacturer profile
EDWARDS LIFESICENCES · NPT
MAUDE profile for Aortic Valve, Prosthesis, Percutaneously Delivered
Key facts
| Manufacturer | EDWARDS LIFESICENCES |
|---|---|
| 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
- Fluid/Blood Leak, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Perivalvular Leak, Difficult to Remove, Material Split, Cut or Torn, Burst Container or Vessel, Malposition of Device 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