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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 21

MDR Year MDR Reports MDR Events
2021 5268 5270
2022 4068 4156
2023 3097 3099
2024 3041 3043
2025 2499 2500
2026 1638 1639

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6439 6440
Material Deformation 4671 4671
Failure to Advance 3874 3874
Device Dislodged or Dislocated 2908 2909
Difficult to Remove 1561 1561
Break 1331 1332
Difficult to Advance 897 898
Positioning Problem 614 614
Improper or Incorrect Procedure or Method 430 431
Fracture 421 421
Material Rupture 412 414
Activation Failure 389 389
Inflation Problem 332 332
Device Damaged by Another Device 313 313
Detachment of Device or Device Component 305 305
Material Separation 296 296
Leak/Splash 250 251
Entrapment of Device 221 221
Activation, Positioning or Separation Problem 219 219
Deformation Due to Compressive Stress 217 217
Obstruction of Flow 183 183
Burst Container or Vessel 172 172
Deflation Problem 163 163
Nonstandard Device 144 144
Device-Device Incompatibility 119 119
Patient-Device Incompatibility 103 188
Failure to Deflate 101 101
Material Split, Cut or Torn 100 100
Use of Device Problem 99 99
Defective Device 96 96
Material Integrity Problem 93 93
Stretched 71 71
Positioning Failure 69 69
Migration 68 68
Difficult to Insert 66 66
Migration or Expulsion of Device 58 58
Off-Label Use 50 50
Difficult or Delayed Activation 50 50
Patient Device Interaction Problem 42 42
Difficult or Delayed Positioning 33 33
Device Markings/Labelling Problem 32 32
Premature Activation 31 31
Device Contamination with Chemical or Other Material 29 29
Contamination 27 27
Fluid/Blood Leak 25 25
Malposition of Device 24 24
Component Missing 24 24
Packaging Problem 20 20
Difficult to Open or Remove Packaging Material 19 19
Product Quality Problem 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11691 11696
Vascular Dissection 3389 3389
Insufficient Information 1141 1141
Myocardial Infarction 902 991
Thrombosis/Thrombus 896 986
Angina 643 643
Restenosis 461 461
Obstruction/Occlusion 406 407
Chest Pain 336 337
Cardiac Arrest 319 319
Device Embedded In Tissue or Plaque 298 298
Reduced Blood Flow 280 280
Stenosis 266 266
Foreign Body In Patient 260 261
No Consequences Or Impact To Patient 193 193
Stroke/CVA 183 268
Unspecified Tissue Injury 164 164
Ischemia 162 162
Hemorrhage/Blood Loss/Bleeding 160 160
Low Blood Pressure/ Hypotension 142 143
Non specific EKG/ECG Changes 130 130
Heart Failure/Congestive Heart Failure 126 126
Perforation of Vessels 118 118
Dyspnea 92 92
Arteriosclerosis/ Atherosclerosis 91 91
Pain 88 88
Unspecified Heart Problem 81 81
Arrhythmia 80 80
Intimal Dissection 77 77
Perforation 70 70
Cardiogenic Shock 68 68
Cardiac Enzyme Elevation 59 59
Bradycardia 57 57
Hypersensitivity/Allergic reaction 55 58
Ventricular Fibrillation 54 54
Hematoma 53 53
Local Reaction 42 42
Aneurysm 41 41
Thrombosis 38 38
Embolism/Embolus 35 35
Atrial Fibrillation 32 32
Death 31 31
High Blood Pressure/ Hypertension 31 31
Cardiac Tamponade 31 31
Discomfort 28 28
Prolapse 25 25
Tachycardia 25 25
Rash 24 27
Pericardial Effusion 24 24
Unspecified Infection 23 23

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