MAUDE manufacturer profile
W. L. GORE & ASSOCIATES, INC. · NIP
MAUDE profile for Stent, Superficial Femoral Artery
Key facts
| Manufacturer | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Manufacturer group | MEDICAL ECHO RIDGE B/P |
| Product code | NIP |
| Product code name | Stent, Superficial Femoral Artery |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Activation Failure, Adverse Event Without Identified Device or Use Problem, Obstruction/Occlusion, Thrombosis/Thrombus, Break, Insufficient Information, Complete Blockage 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