MAUDE manufacturer profile
EDWARDS LIFSCIENCES · NPT
MAUDE profile for Aortic Valve, Prosthesis, Percutaneously Delivered
Key facts
| Manufacturer | EDWARDS LIFSCIENCES |
|---|---|
| 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, Material Twisted/Bent, Vascular Dissection, Difficult to Remove, No Clinical Signs, Symptoms or Conditions, Material Rupture, Device Dislodged or Dislocated, Insufficient Information 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