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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)
2015 2016 2017 2018 2019 2020
45 72 53 61 59 36

MDR Year MDR Reports MDR Events
2015 6141 6141
2016 7233 7233
2017 6786 6786
2018 6816 6816
2019 7254 7254
2020 4050 4050

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11435 11435
Stent 7767 7767
Material Deformation 6298 6298
Failure to Advance 5951 5951
Device Dislodged or Dislocated 4623 4623
Bent 4586 4586
Catheter 3534 3534
Difficult to Remove 2026 2026
Occlusion Within Device 1651 1651
Break 1597 1597
Device Damaged Prior to Use 1041 1041
Shaft 978 978
Device Damaged by Another Device 727 727
Detachment Of Device Component 662 662
Improper or Incorrect Procedure or Method 656 656
Difficult to Advance 511 511
Inflation Problem 480 480
Activation, Positioning or SeparationProblem 456 456
Material Rupture 434 434
Fracture 392 392
Difficult To Position 338 338
Balloon 330 330
Kinked 323 323
Deflation Problem 289 289
Leak/Splash 271 271
Material Separation 241 241
Entrapment of Device 239 239
Detachment of Device or Device Component 199 199
Obstruction of Flow 193 193
Difficult or Delayed Positioning 188 188
Migration or Expulsion of Device 145 145
Physical Resistance 137 137
Positioning Failure 131 131
Activation Failure 128 128
Burst Container or Vessel 124 124
Device Expiration Issue 102 102
Material Twisted/Bent 100 100
Patient-Device Incompatibility 95 95
Defective Device 93 93
Unstable 80 80
Stretched 71 71
Insufficient Information 68 68
Malposition of Device 66 66
Physical Resistance/Sticking 60 60
Deformation Due to Compressive Stress 59 59
Migration 57 57
Torn Material 55 55
Device Contamination with Chemical or Other Material 53 53
Difficult to Insert 50 50
Material Integrity Problem 45 45
Device-Device Incompatibility 42 42
Tip 42 42
Positioning Problem 40 40
Device Operates Differently Than Expected 39 39
Device Markings/Labelling Problem 38 38
Use of Device Problem 37 37
Component Missing 30 30
Tear, Rip or Hole in Device Packaging 26 26
Difficult or Delayed Activation 26 26
Premature Activation 25 25
Appropriate Term/Code Not Available 20 20
Material Split, Cut or Torn 20 20
Defective Component 20 20
Contamination 18 18
Crack 18 18
Device Or Device Fragments Location Unknown 17 17
Unsealed Device Packaging 16 16
Inadequacy of Device Shape and/or Size 16 16
Contamination /Decontamination Problem 15 15
Device Misassembled During Manufacturing /Shipping 15 15
Patient Device Interaction Problem 15 15
Product Quality Problem 14 14
Unintended System Motion 12 12
Unintended Movement 12 12
Physical Property Issue 12 12
Hole In Material 12 12
Off-Label Use 11 11
Peeled/Delaminated 11 11
Material Distortion 10 10
Sticking 9 9
Collapse 9 9
Device Slipped 9 9
Retraction Problem 9 9
Material Protrusion/Extrusion 9 9
Packaging Problem 8 8
Inaccurate Delivery 8 8
Material Puncture/Hole 8 8
Loose or Intermittent Connection 8 8
Failure To Adhere Or Bond 8 8
Wire 7 7
Guidewire 7 7
Hub 7 7
Failure to Fold 7 7
Device Packaging Compromised 7 7
Folded 7 7
Mechanical Jam 7 7
Fluid Leak 6 6
Label 6 6
Material Frayed 5 5
Mechanical Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 20136 20136
Intimal Dissection 3004 3004
Myocardial Infarction 2943 2944
Death 2580 2580
No Patient Involvement 2191 2191
Thrombosis 1927 1927
Angina 1778 1778
No Known Impact Or Consequence To Patient 997 997
Reocclusion 993 993
Stenosis 962 962
Occlusion 834 834
Chest Pain 813 813
Patient Problem/Medical Problem 658 658
Thrombus 649 649
Dyspnea 494 494
Stroke/CVA 484 484
Vascular Dissection 418 418
Cardiac Arrest 413 413
Cardiac Enzyme Elevation 370 370
Blood Loss 354 354
Injury 345 345
No Code Available 321 321
Low Blood Pressure/ Hypotension 251 251
ST Segment Elevation 242 242
Foreign Body In Patient 221 221
Device Embedded In Tissue or Plaque 211 211
Non specific EKG/ECG Changes 208 208
Obstruction/Occlusion 200 200
Ischemia 192 192
Perforation 155 155
Heart Failure 151 151
Hypersensitivity/Allergic reaction 140 140
Vessel Or Plaque, Device Embedded In 130 130
Ventricular Fibrillation 130 130
Bradycardia 130 130
Cardiogenic Shock 118 118
Congestive Heart Failure 111 111
Ventricular Tachycardia 108 108
Reaction 104 104
Arrhythmia 103 103
Nausea 99 99
Embolism 96 96
Respiratory Failure 86 86
High Blood Pressure/ Hypertension 82 82
Atrial Fibrillation 72 72
Pain 70 70
No Information 69 69
Perforation of Vessels 66 66
Prolapse 65 65
Diaphoresis 63 63
Fatigue 61 61
Hemorrhage/Bleeding 54 54
Cardiac Tamponade 50 50
Chest Tightness/Pressure 48 48
Cardiopulmonary Arrest 46 46
Aneurysm 46 46
Dizziness 45 45
Test Result 41 41
Hematoma 41 41
Renal Failure 41 41
Vasoconstriction 39 39
Cardiomyopathy 36 36
Pulmonary Edema 36 36
Syncope 34 34
Atherosclerosis 34 34
Weakness 32 32
Respiratory Distress 31 31
Vomiting 31 31
Rash 29 29
Unspecified Infection 28 28
Pneumonia 26 26
Shock 26 26
Pericardial Effusion 26 26
Loss Of Pulse 23 23
Sudden Cardiac Death 22 22
Sepsis 22 22
Anemia 19 19
Edema 19 19
Numbness 18 18
Headache 17 17
ST Segment Depression 17 17
Discomfort 15 15
Ischemic Heart Disease 15 15
Tachycardia 14 14
Inflammation 13 13
Neurological Deficit/Dysfunction 12 12
Rupture 12 12
Swelling 11 11
Calcium Deposits/Calcification 11 11
Complaint, Ill-Defined 11 11
Pseudoaneurysm 11 11
Pleural Effusion 10 10
Hypoxia 10 10
Air Embolism 10 10
Fever 10 10
Loss of consciousness 10 10
Infarction, Cerebral 9 9
Complete Heart Block 8 8
Hemorrhage, Cerebral 8 8
Septic Shock 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Jun-15-2020
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