Definition: Stent, Coronary, Drug-eluting -- A Metal Scaffold With A Drug Coating Placed Via A Delivery Catheter Into The Coronary Artery Or Saphenous Vein Graft To Maintain The Lumen. The Drug Coating Is Intended To Inhibit Restenosis.
| Device Type ID | 1050 |
| Device Name | Coronary Drug-eluting Stent |
| 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 | NIQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1050 |
| Device | Coronary Drug-eluting Stent |
| Product Code | NIQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Stent | 6266 |
Adverse Event Without Identified Device Or Use Problem | 4494 |
Bent | 4039 |
Failure To Advance | 3002 |
Catheter | 2705 |
Device Dislodged Or Dislocated | 2560 |
Material Deformation | 2122 |
Occlusion Within Device | 1448 |
Device Damaged Prior To Use | 972 |
Break | 908 |
Shaft | 861 |
Difficult To Remove | 690 |
Device Damaged By Another Device | 500 |
Activation, Positioning Or Separation Problem | 336 |
Fracture | 249 |
Balloon | 225 |
Difficult To Advance | 167 |
Inflation Problem | 164 |
Material Rupture | 158 |
Entrapment Of Device | 154 |
Kinked | 152 |
Improper Or Incorrect Procedure Or Method | 116 |
Detachment Of Device Component | 113 |
Leak / Splash | 109 |
Obstruction Of Flow | 106 |
Deflation Problem | 102 |
Material Twisted / Bent | 92 |
Detachment Of Device Or Device Component | 82 |
Material Separation | 81 |
Migration Or Expulsion Of Device | 81 |
Burst Container Or Vessel | 69 |
Difficult To Position | 55 |
Malposition Of Device | 51 |
Difficult Or Delayed Positioning | 51 |
Device Expiration Issue | 48 |
Stretched | 40 |
Activation Failure Including Expansion Failures | 40 |
Defective Device | 34 |
Device Contamination With Chemical Or Other Material | 34 |
Positioning Failure | 33 |
Deformation Due To Compressive Stress | 26 |
Patient-Device Incompatibility | 25 |
Device Markings / Labelling Problem | 25 |
Tip | 20 |
Difficult To Insert | 19 |
Premature Activation | 19 |
Migration | 18 |
Device Or Device Fragments Location Unknown | 17 |
Defective Component | 16 |
Positioning Problem | 12 |
Hole In Material | 11 |
Inadequacy Of Device Shape And/or Size | 11 |
Device-Device Incompatibility | 11 |
Physical Resistance | 11 |
Material Integrity Problem | 10 |
Use Of Device Problem | 10 |
Contamination / Decontamination Problem | 10 |
Unintended System Motion | 9 |
Insufficient Information | 9 |
Material Distortion | 8 |
Difficult Or Delayed Activation | 8 |
Inaccurate Delivery | 7 |
Unintended Movement | 7 |
Off-Label Use | 7 |
Contamination During Use | 7 |
Product Quality Problem | 7 |
Unstable | 6 |
Tear, Rip Or Hole In Device Packaging | 6 |
Failure To Adhere Or Bond | 6 |
Device Operates Differently Than Expected | 6 |
Label | 6 |
Device Packaging Compromised | 6 |
Unsealed Device Packaging | 6 |
Torn Material | 6 |
Physical Resistance / Sticking | 5 |
Failure To Fold | 5 |
Material Split, Cut Or Torn | 5 |
Retraction Problem | 4 |
Component Missing | 4 |
Peeled / Delaminated | 4 |
Device Slipped | 4 |
Difficult To Open Or Remove Packaging Material | 3 |
Hub | 3 |
Therapy Delivered To Incorrect Body Area | 3 |
Expulsion | 3 |
Seal | 3 |
Incorrect Measurement | 2 |
Device Difficult To Setup Or Prepare | 2 |
Material Puncture / Hole | 2 |
Appropriate Term/Code Not Available | 2 |
Separation Failure | 2 |
Device Disinfection Or Sterilization Issue | 2 |
Packaging Problem | 2 |
Material Perforation | 2 |
Fluid Leak | 2 |
Mechanical Problem | 2 |
Crack | 2 |
Display Or Visual Feedback Problem | 1 |
Stylet | 1 |
Shelf Life Exceeded | 1 |
| Total Device Problems | 33968 |