MAUDE manufacturer profile
ABBOTT VASCULAR · NKM
MAUDE profile for Mitral Valve Repair Devices
Key facts
| Manufacturer | ABBOTT VASCULAR |
|---|---|
| Manufacturer group | ABBOTT VASCULAR, REG # 3005070406 |
| Product code | NKM |
| Product code name | Mitral Valve Repair Devices |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Incomplete Coaptation, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Unintended Movement, Mitral Regurgitation, Difficult to Open or Close, Mitral Valve Insufficiency/ Regurgitation 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