MAUDE manufacturer profile
W. L. GORE & ASSOCIATES, INC. · MLV
MAUDE profile for Transcatheter Septal Occluder
Key facts
| Manufacturer | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Manufacturer group | KENDRICK PEAK MPD B/P |
| Product code | MLV |
| Product code name | Transcatheter Septal Occluder |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Atrial Fibrillation, Pericardial Effusion, Thrombosis/Thrombus, Migration, Patient Device Interaction Problem, No Clinical Signs, Symptoms or Conditions, Foreign Body Embolism 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