Definition: Stent, Superficial Femoral Artery, Drug-Eluting -- A Metal Scaffold With A Drug Coating Placed Via A Delivery Catheter Into The Superficial Femoral Artery Artery To Maintain The Lumen. The Drug Coating Is Intended To Inhibit Restenosis.
| Device Type ID | 1051 |
| Device Name | Stent, Superficial Femoral Artery, Drug-eluting |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NIU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1051 |
| Device | Stent, Superficial Femoral Artery, Drug-eluting |
| Product Code | NIU |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Occlusion Within Device | 395 |
Stent | 325 |
Activation, Positioning Or Separation Problem | 180 |
Fracture | 142 |
Adverse Event Without Identified Device Or Use Problem | 98 |
Stretched | 37 |
Delivery System Failure | 30 |
Difficult To Remove | 26 |
Catheter | 23 |
Bent | 15 |
Break | 15 |
Entrapment Of Device | 15 |
Obstruction Of Flow | 13 |
Difficult Or Delayed Positioning | 8 |
Device Operates Differently Than Expected | 8 |
Device Deployer | 8 |
Device Expiration Issue | 8 |
Premature Activation | 7 |
Appropriate Term/Code Not Available | 7 |
Activation Failure Including Expansion Failures | 5 |
Difficult To Open Or Remove Packaging Material | 5 |
Packaging Problem | 5 |
Material Deformation | 5 |
Device Packaging Compromised | 4 |
Kinked | 4 |
Positioning Problem | 3 |
Insufficient Information | 3 |
Mechanical Problem | 3 |
Detachment Of Device Component | 3 |
No Apparent Adverse Event | 3 |
Use Of Device Problem | 2 |
Shaft | 2 |
Infusion Or Flow Problem | 2 |
Migration Or Expulsion Of Device | 2 |
Positioning Failure | 2 |
Shelf Life Exceeded | 2 |
Restricted Flow Rate | 2 |
Malposition Of Device | 2 |
Device Disinfection Or Sterilization Issue | 2 |
Difficult To Advance | 2 |
Material Perforation | 1 |
Implant, Removal Of | 1 |
Defective Device | 1 |
Material Fragmentation | 1 |
Folded | 1 |
Device Damaged By Another Device | 1 |
Difficult To Fold Or Unfold | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Expiration Date Error | 1 |
Human-Device Interface Problem | 1 |
Compatibility Problem | 1 |
Migration | 1 |
Deformation Due To Compressive Stress | 1 |
Tip | 1 |
| Total Device Problems | 1437 |