MAUDE manufacturer profile
BIOTRONIK AG · NIV
MAUDE profile for Coronary Covered Stent
Key facts
| Manufacturer | BIOTRONIK AG |
|---|---|
| Manufacturer group | BIOTRONIK AG |
| Product code | NIV |
| Product code name | Coronary Covered Stent |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Failure to Advance, Device Dislodged or Dislocated, Lack of Effect, Material Rupture, Perforation of Vessels, Material Split, Cut or Torn, Difficult to Remove 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