MAUDE manufacturer profile
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR · OUT
MAUDE profile for Intracranial Aneurysm Flow Diverter
Key facts
| Manufacturer | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|---|---|
| Manufacturer group | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| Product code | OUT |
| Product code name | Intracranial Aneurysm Flow Diverter |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Activation Failure, No Known Impact Or Consequence To Patient, Difficult to Open or Close, Adverse Event Without Identified Device or Use Problem, Physical Resistance, Physical Resistance/Sticking, Positioning Problem, Mechanical Jam 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