Definition: Treatment Of Wide-necked And Larger Or Giant Intracranial Aneurysms.
| Device Type ID | 3858 |
| Device Name | Intracranial Aneurysm Flow Diverter |
| Physical State | Metallic |
| Technical Method | Interventional |
| Target Area | Neurovasculature |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OUT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3858 |
| Device | Intracranial Aneurysm Flow Diverter |
| Product Code | OUT |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Activation Failure Including Expansion Failures | 823 |
Adverse Event Without Identified Device Or Use Problem | 556 |
Break | 87 |
Migration Or Expulsion Of Device | 68 |
Positioning Failure | 58 |
Physical Resistance | 47 |
Detachment Of Device Or Device Component | 25 |
Physical Resistance / Sticking | 15 |
Difficult To Position | 12 |
Appropriate Term/Code Not Available | 11 |
Positioning Problem | 10 |
Retraction Problem | 8 |
Migration | 7 |
Flaked | 6 |
Material Deformation | 4 |
Delamination | 4 |
Activation, Positioning Or Separation Problem | 4 |
Difficult Or Delayed Activation | 3 |
Premature Separation | 3 |
Kinked | 2 |
Collapse | 2 |
Unintended Movement | 2 |
Detachment Of Device Component | 2 |
Material Separation | 2 |
Device Dislodged Or Dislocated | 2 |
Device Operates Differently Than Expected | 2 |
Difficult To Remove | 2 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Activation Problem | 1 |
Difficult To Open Or Close | 1 |
Balloon | 1 |
Material Frayed | 1 |
Device Damaged By Another Device | 1 |
Device Slipped | 1 |
Stretched | 1 |
Component Falling | 1 |
| Total Device Problems | 1777 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Micro Therapeutics Inc, Dba Ev3 Neurovascular | I | Nov-09-2016 |
| 2 | Micro Therapeutics Inc, Dba Ev3 Neurovascular | II | Oct-14-2015 |