MAUDE manufacturer profile
MICRO THERAPEUTICS, INC. DBA EV3 · OUT
MAUDE profile for Intracranial Aneurysm Flow Diverter
Key facts
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
|---|---|
| Manufacturer group | MICRO THERAPEUTICS, INC. DBA EV3 |
| Product code | OUT |
| Product code name | Intracranial Aneurysm Flow Diverter |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Activation Failure, Physical Resistance/Sticking, Adverse Event Without Identified Device or Use Problem, Material Deformation, No Known Impact Or Consequence To Patient, Activation, Positioning or Separation Problem, Unintended Movement 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