Definition: Stent, Carotid -- A Metal Scaffold Placed Via A Delivery Catheter Into The Carotid Artery To Maintain The Lumen
| Device Type ID | 1046 |
| Device Name | Stent, Carotid |
| 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 | NIM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1046 |
| Device | Stent, Carotid |
| Product Code | NIM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Stent | 123 |
Adverse Event Without Identified Device Or Use Problem | 75 |
Catheter | 60 |
Difficult Or Delayed Positioning | 44 |
Activation, Positioning Or Separation Problem | 39 |
Detachment Of Device Component | 30 |
Material Deformation | 21 |
Difficult To Remove | 21 |
Premature Activation | 14 |
Crack | 13 |
Bent | 12 |
Tip | 11 |
Entrapment Of Device | 11 |
Shaft | 10 |
Failure To Advance | 10 |
Fracture | 9 |
Device Damaged Prior To Use | 9 |
Break | 9 |
Difficult To Advance | 8 |
Positioning Failure | 8 |
Material Separation | 8 |
Device Dislodged Or Dislocated | 8 |
Retraction Problem | 7 |
Migration Or Expulsion Of Device | 7 |
Detachment Of Device Or Device Component | 7 |
Device Damaged By Another Device | 5 |
Material Frayed | 5 |
Activation Failure Including Expansion Failures | 5 |
Occlusion Within Device | 3 |
Material Split, Cut Or Torn | 3 |
Migration | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Insufficient Information | 3 |
Inaccurate Delivery | 3 |
Torn Material | 2 |
Hub | 2 |
Positioning Problem | 2 |
Difficult To Insert | 2 |
Kinked | 2 |
Device Packaging Compromised | 2 |
Mechanical Jam | 1 |
Folded | 1 |
Component Or Accessory Incompatibility | 1 |
Unsealed Device Packaging | 1 |
Off-Label Use | 1 |
Sticking | 1 |
Device-Device Incompatibility | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Partial Blockage | 1 |
Leak / Splash | 1 |
Malposition Of Device | 1 |
Material Distortion | 1 |
Shelf Life Exceeded | 1 |
Collapse | 1 |
Device Expiration Issue | 1 |
Material Too Soft / Flexible | 1 |
Material Integrity Problem | 1 |
Guidewire | 1 |
Failure To Adhere Or Bond | 1 |
Failure To Capture | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Defective Component | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Seal | 1 |
Component Missing | 1 |
Capturing Problem | 1 |
Difficult To Flush | 1 |
T-Piece Connector | 1 |
Premature Discharge Of Battery | 1 |
Wire | 1 |
| Total Device Problems | 650 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cordis Corporation | II | Jun-10-2016 |
| 2 | Ev3, Inc. | II | Dec-29-2014 |