MAUDE manufacturer profile
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA · OUT
MAUDE profile for Intracranial Aneurysm Flow Diverter
Key facts
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA |
|---|---|
| Manufacturer group | MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA |
| Product code | OUT |
| Product code name | Intracranial Aneurysm Flow Diverter |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Activation Failure, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Death, Neurological Deficit/Dysfunction, Thrombosis, Physical Resistance/Sticking, Intracranial Hemorrhage 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