Definition: The Formerly Known Device, Cardiovascular Stent, Coded As "MAF" Has Been Modified And Is Currently Known And Classified As A "Coronary Stent". This Device Is A Metal Scaffold Placed Via A Delivery Catheter Into The Coronary Artery Or Saphenous Vein G
| Device Type ID | 1023 |
| Device Name | Stent, Coronary |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MAF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1023 |
| Device | Stent, Coronary |
| Product Code | MAF |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Stent | 320 |
Failure To Advance | 258 |
Adverse Event Without Identified Device Or Use Problem | 236 |
Device Dislodged Or Dislocated | 201 |
Bent | 180 |
Material Deformation | 93 |
Catheter | 88 |
Improper Or Incorrect Procedure Or Method | 58 |
Device Damaged Prior To Use | 54 |
Break | 46 |
Patient-Device Incompatibility | 46 |
Difficult To Remove | 42 |
Shaft | 41 |
Difficult To Advance | 27 |
Occlusion Within Device | 25 |
Fracture | 23 |
Balloon | 22 |
Leak / Splash | 22 |
Material Separation | 21 |
Activation, Positioning Or Separation Problem | 17 |
Off-Label Use | 16 |
Material Rupture | 16 |
Device Damaged By Another Device | 15 |
Detachment Of Device Component | 14 |
Device Expiration Issue | 13 |
Detachment Of Device Or Device Component | 13 |
Inflation Problem | 13 |
Deformation Due To Compressive Stress | 12 |
Insufficient Information | 10 |
Difficult Or Delayed Activation | 8 |
Malposition Of Device | 8 |
Entrapment Of Device | 8 |
Kinked | 7 |
Burst Container Or Vessel | 7 |
Material Twisted / Bent | 6 |
Deflation Problem | 6 |
Activation Failure Including Expansion Failures | 5 |
Migration Or Expulsion Of Device | 5 |
Difficult To Position | 5 |
Difficult Or Delayed Positioning | 4 |
Failure To Deliver | 3 |
Defective Device | 3 |
Positioning Failure | 3 |
Device Issue | 3 |
Unsealed Device Packaging | 2 |
Device Packaging Compromised | 2 |
Expulsion | 2 |
Partial Blockage | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Premature Activation | 2 |
Difficult To Insert | 2 |
Use Of Device Problem | 2 |
Component Missing | 2 |
Tip | 2 |
Physical Resistance | 2 |
Device Operates Differently Than Expected | 1 |
Power Problem | 1 |
Migration | 1 |
Failure To Capture | 1 |
Product Quality Problem | 1 |
Unexpected Therapeutic Results | 1 |
Unstable | 1 |
Material Split, Cut Or Torn | 1 |
Failure To Unwrap | 1 |
Incorrect Measurement | 1 |
Material Puncture / Hole | 1 |
Label | 1 |
Protector | 1 |
Unintended System Motion | 1 |
Self-Activation Or Keying | 1 |
Contamination / Decontamination Problem | 1 |
Hub | 1 |
Device Markings / Labelling Problem | 1 |
Malfunction | 1 |
Stretched | 1 |
Stylet | 1 |
Fluid Leak | 1 |
Mechanical Problem | 1 |
Unintended Movement | 1 |
Peeled / Delaminated | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Material Too Rigid Or Stiff | 1 |
Separation Failure | 1 |
Folded | 1 |
| Total Device Problems | 2074 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cordis Corporation | II | Apr-15-2017 |