MAUDE manufacturer profile
AV-TEMECULA-CT · NIQ
MAUDE profile for Coronary Drug-Eluting Stent
Key facts
| Manufacturer | AV-TEMECULA-CT |
|---|---|
| Manufacturer group | CLONMEL, IRELAND REG# 9616693 |
| Product code | NIQ |
| Product code name | Coronary Drug-Eluting Stent |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, Intimal Dissection, Failure to Advance, Difficult to Remove, Angina, Device Dislodged or Dislocated, Detachment Of Device Component 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