Definition: For The Treatment Of De Novo Or Restenotic Lesions Found In Iliac Arteries
| Device Type ID | 1086 |
| Device Name | Iliac Covered Stent, Arterial |
| Physical State | Metallic Tube With Graft Covering |
| Technical Method | Physical Mesh Tube Placed In The Vessel To Hold Open |
| Target Area | Iliac Arteries |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PRL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1086 |
| Device | Iliac Covered Stent, Arterial |
| Product Code | PRL |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 61 |
Device-Device Incompatibility | 45 |
Occlusion Within Device | 7 |
Obstruction Of Flow | 6 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Activation, Positioning Or Separation Problem | 4 |
No Apparent Adverse Event | 2 |
Material Split, Cut Or Torn | 2 |
Failure To Advance | 2 |
Migration Or Expulsion Of Device | 2 |
Appropriate Term/Code Not Available | 1 |
Retraction Problem | 1 |
Structural Problem | 1 |
Material Deformation | 1 |
Material Rupture | 1 |
Delivery System Failure | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 143 |