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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coronary drug-eluting stent
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.
Product CodeNIQ
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
63 45 49 35 28 3

MDR Year MDR Reports MDR Events
2021 5268 5270
2022 4068 4156
2023 3097 3099
2024 3041 3043
2025 2499 2500
2026 226 226

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6058 6059
Material Deformation 4403 4403
Failure to Advance 3571 3571
Device Dislodged or Dislocated 2709 2710
Difficult to Remove 1478 1479
Break 1269 1271
Difficult to Advance 834 835
Positioning Problem 497 497
Material Rupture 385 387
Improper or Incorrect Procedure or Method 384 385
Fracture 377 377
Activation Failure 353 353
Inflation Problem 311 311
Detachment of Device or Device Component 302 302
Material Separation 287 287
Device Damaged by Another Device 279 279
Leak/Splash 233 233
Activation, Positioning or Separation Problem 221 221
Entrapment of Device 199 199
Deformation Due to Compressive Stress 181 181
Obstruction of Flow 161 161
Burst Container or Vessel 156 156
Deflation Problem 154 154
Device-Device Incompatibility 118 118
Patient-Device Incompatibility 98 186
Material Split, Cut or Torn 97 97
Defective Device 96 96
Material Integrity Problem 93 93
Failure to Deflate 91 91
Use of Device Problem 85 85
Positioning Failure 72 72
Difficult to Insert 64 64
Stretched 62 62
Migration 59 59
Migration or Expulsion of Device 52 52
Off-Label Use 47 47
Difficult or Delayed Activation 45 45
Patient Device Interaction Problem 43 43
Difficult or Delayed Positioning 36 36
Nonstandard Device 34 34
Device Markings/Labelling Problem 31 31
Premature Activation 30 30
Malposition of Device 26 26
Contamination 26 26
Device Contamination with Chemical or Other Material 25 25
Physical Resistance/Sticking 22 22
Component Missing 21 21
Fluid/Blood Leak 21 21
Product Quality Problem 18 18
Material Puncture/Hole 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10769 10773
Vascular Dissection 3174 3174
Insufficient Information 1132 1132
Thrombosis/Thrombus 840 930
Myocardial Infarction 836 925
Angina 622 622
Restenosis 409 409
Obstruction/Occlusion 369 370
Cardiac Arrest 293 293
Chest Pain 293 294
Device Embedded In Tissue or Plaque 269 269
Stenosis 255 255
Foreign Body In Patient 226 227
No Consequences Or Impact To Patient 193 193
Stroke/CVA 170 255
Unspecified Tissue Injury 162 162
Ischemia 155 155
Hemorrhage/Bleeding 148 148
Non specific EKG/ECG Changes 123 123
Heart Failure/Congestive Heart Failure 122 122
Low Blood Pressure/ Hypotension 118 119
Perforation of Vessels 108 108
Arteriosclerosis/ Atherosclerosis 85 85
Dyspnea 84 84
Pain 78 78
Intimal Dissection 77 77
Arrhythmia 75 75
Perforation 66 66
Unspecified Heart Problem 65 65
Cardiogenic Shock 61 61
Hypersensitivity/Allergic reaction 52 55
Ventricular Fibrillation 50 50
Hematoma 49 49
Bradycardia 46 46
Cardiac Enzyme Elevation 43 43
Aneurysm 39 39
Local Reaction 39 39
Thrombosis 38 38
Embolism/Embolus 35 35
Death 31 31
High Blood Pressure/ Hypertension 29 29
Atrial Fibrillation 29 29
Cardiac Tamponade 28 28
Discomfort 25 25
Rash 23 26
Tachycardia 23 23
Pericardial Effusion 22 22
Prolapse 22 22
Transient Ischemic Attack 19 19
Ischemic Heart Disease 19 19

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