Definition: Stent, Renal -- A Metal Scaffold Placed Via A Delivery Catheter Into The Renal Artery To Maintain The Lumen
| Device Type ID | 1047 |
| Device Name | Stent, Renal |
| 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 | NIN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1047 |
| Device | Stent, Renal |
| Product Code | NIN |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Dislodged Or Dislocated | 30 |
Failure To Advance | 13 |
Difficult To Remove | 10 |
Difficult To Advance | 10 |
Improper Or Incorrect Procedure Or Method | 9 |
Stent | 8 |
Detachment Of Device Component | 6 |
Off-Label Use | 6 |
Balloon | 5 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Inflation Problem | 4 |
Premature Activation | 4 |
Difficult To Insert | 3 |
Material Deformation | 3 |
Activation, Positioning Or Separation Problem | 3 |
Catheter | 3 |
Unintended System Motion | 2 |
Burst Container Or Vessel | 2 |
Leak / Splash | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Positioning Failure | 2 |
Device Handling Problem | 1 |
Kinked | 1 |
Malposition Of Device | 1 |
Break | 1 |
Difficult To Position | 1 |
Migration Or Expulsion Of Device | 1 |
Expiration Date Error | 1 |
Unstable | 1 |
Activation Failure Including Expansion Failures | 1 |
Shaft | 1 |
Difficult Or Delayed Positioning | 1 |
Occlusion Within Device | 1 |
| Total Device Problems | 144 |