Definition: Stent, Iliac -- A Metal Scaffold Placed Via A Delivery Catheter Into The Iliac Artery To Maintain The Lumen
| Device Type ID | 1048 |
| Device Name | Stent, Iliac |
| 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 | NIO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1048 |
| Device | Stent, Iliac |
| Product Code | NIO |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Stent | 335 |
Adverse Event Without Identified Device Or Use Problem | 143 |
Device Dislodged Or Dislocated | 140 |
Activation, Positioning Or Separation Problem | 99 |
Difficult To Remove | 94 |
Difficult Or Delayed Positioning | 69 |
Premature Activation | 69 |
Catheter | 51 |
Detachment Of Device Or Device Component | 49 |
Positioning Failure | 47 |
Bent | 42 |
Failure To Advance | 42 |
Fracture | 40 |
Occlusion Within Device | 40 |
Break | 36 |
Difficult To Advance | 36 |
Material Deformation | 34 |
Migration Or Expulsion Of Device | 30 |
Improper Or Incorrect Procedure Or Method | 30 |
Device Contaminated During Manufacture Or Shipping | 27 |
Device Damaged Prior To Use | 23 |
Entrapment Of Device | 21 |
Tip | 20 |
Detachment Of Device Component | 19 |
Off-Label Use | 17 |
Activation Failure Including Expansion Failures | 17 |
Material Frayed | 16 |
Shaft | 14 |
Difficult To Position | 14 |
Device Expiration Issue | 13 |
Mechanical Jam | 13 |
Material Separation | 12 |
Difficult Or Delayed Activation | 12 |
Malposition Of Device | 12 |
Obstruction Of Flow | 12 |
Device Operates Differently Than Expected | 11 |
Torn Material | 11 |
Device Markings / Labelling Problem | 9 |
Positioning Problem | 9 |
Defective Component | 9 |
Deformation Due To Compressive Stress | 8 |
Misfire | 7 |
Balloon | 7 |
Material Rupture | 7 |
Insufficient Information | 7 |
Collapse | 7 |
Delivery System Failure | 7 |
Device Contamination With Chemical Or Other Material | 7 |
Physical Resistance / Sticking | 6 |
Device Damaged By Another Device | 6 |
Patient-Device Incompatibility | 6 |
Inflation Problem | 5 |
Burst Container Or Vessel | 5 |
Device Deployer | 5 |
Migration | 5 |
Sticking | 5 |
Stretched | 5 |
Kinked | 5 |
Defective Device | 4 |
Unsealed Device Packaging | 4 |
Failure To Adhere Or Bond | 4 |
Deflation Problem | 4 |
Retraction Problem | 4 |
Appropriate Term/Code Not Available | 4 |
Use Of Device Problem | 3 |
Physical Resistance | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Leak / Splash | 3 |
Inaccurate Delivery | 3 |
Premature Separation | 3 |
Difficult To Insert | 2 |
Therapy Delivered To Incorrect Body Area | 2 |
Patient Device Interaction Problem | 2 |
Material Twisted / Bent | 2 |
Unstable | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Guidewire | 2 |
Material Integrity Problem | 2 |
Component Missing | 2 |
Contamination / Decontamination Problem | 2 |
Label | 1 |
Failure To Fold | 1 |
Unintended Ejection | 1 |
Seal | 1 |
Material Split, Cut Or Torn | 1 |
Compatibility Problem | 1 |
Expiration Date Error | 1 |
Material Protrusion / Extrusion | 1 |
Complete Blockage | 1 |
Material Fragmentation | 1 |
Hole In Material | 1 |
Separation Failure | 1 |
Folded | 1 |
Accessory Incompatible | 1 |
Partial Blockage | 1 |
Device-Device Incompatibility | 1 |
Unintended Movement | 1 |
Failure To Disconnect | 1 |
Material Perforation | 1 |
Packaging Problem | 1 |
| Total Device Problems | 1929 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Medical Incorporated | II | Jan-22-2016 |