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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)
2017 2018 2019 2020 2021 2022
53 61 59 62 62 1

MDR Year MDR Reports MDR Events
2017 6786 6786
2018 6817 6817
2019 7254 7254
2020 6362 6362
2021 5267 5267

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10329 10329
Material Deformation 7728 7728
Failure to Advance 5393 5393
Device Dislodged or Dislocated 3668 3668
Bent 2050 2050
Difficult to Remove 1685 1685
Break 1532 1532
Difficult to Advance 812 812
Occlusion Within Device 555 555
Improper or Incorrect Procedure or Method 493 493
Device Damaged by Another Device 431 431
Device Damaged Prior to Use 392 392
Inflation Problem 388 388
Material Rupture 349 349
Fracture 340 340
Material Separation 327 327
Activation, Positioning or SeparationProblem 297 297
Obstruction of Flow 273 273
Deflation Problem 272 272
Detachment of Device or Device Component 243 243
Activation Failure 240 240
Detachment Of Device Component 207 207
Leak/Splash 206 206
Entrapment of Device 190 190
Burst Container or Vessel 139 139
Kinked 126 126
Patient-Device Incompatibility 121 121
Difficult To Position 109 109
Material Twisted/Bent 104 104
Defective Device 102 102
Difficult or Delayed Positioning 96 96
Positioning Failure 94 94
Device-Device Incompatibility 92 92
Migration or Expulsion of Device 84 84
Deformation Due to Compressive Stress 80 80
Material Integrity Problem 78 78
Migration 77 77
Physical Resistance/Sticking 73 73
Use of Device Problem 71 71
Malposition of Device 59 59
Physical Resistance 58 58
Positioning Problem 54 54
Stretched 53 53
Difficult to Insert 51 51
Insufficient Information 47 47
Device Contamination with Chemical or Other Material 46 46
Patient Device Interaction Problem 44 44
Difficult or Delayed Activation 43 43
Unstable 39 39
Material Split, Cut or Torn 37 37
Device Markings/Labelling Problem 36 36
Off-Label Use 33 33
Component Missing 26 26
Premature Activation 25 25
Device Expiration Issue 24 24
Tear, Rip or Hole in Device Packaging 24 24
Unintended System Motion 23 23
Device Operates Differently Than Expected 22 22
Appropriate Term/Code Not Available 19 19
Product Quality Problem 19 19
Torn Material 18 18
Inadequacy of Device Shape and/or Size 17 17
Contamination 15 15
Defective Component 14 14
Packaging Problem 14 14
Contamination /Decontamination Problem 14 14
Unsealed Device Packaging 13 13
Crack 12 12
Loose or Intermittent Connection 10 10
Failure to Fold 9 9
Peeled/Delaminated 9 9
Device Misassembled During Manufacturing /Shipping 9 9
Physical Property Issue 9 9
No Apparent Adverse Event 8 8
Difficult to Open or Remove Packaging Material 8 8
Material Puncture/Hole 8 8
Retraction Problem 8 8
Fluid Leak 8 8
Mechanical Problem 7 7
Hole In Material 7 7
Unintended Movement 7 7
Mechanical Jam 6 6
Material Too Soft/Flexible 6 6
Device Or Device Fragments Location Unknown 6 6
Structural Problem 5 5
Human-Device Interface Problem 5 5
Material Protrusion/Extrusion 5 5
Material Distortion 4 4
Inaccurate Delivery 4 4
Collapse 4 4
Partial Blockage 4 4
Complete Blockage 4 4
Material Too Rigid or Stiff 4 4
Device Difficult to Setup or Prepare 4 4
Unraveled Material 4 4
Device Slipped 4 4
Sticking 3 3
Therapy Delivered to Incorrect Body Area 3 3
Calcified 3 3
Failure To Adhere Or Bond 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 14689 14690
No Clinical Signs, Symptoms or Conditions 3708 3708
Myocardial Infarction 2718 2719
Intimal Dissection 2116 2116
Death 1793 1793
Angina 1268 1268
Thrombosis 1183 1183
No Patient Involvement 1168 1168
Vascular Dissection 1037 1037
No Known Impact Or Consequence To Patient 745 745
Stenosis 720 720
Occlusion 687 687
Thrombus 535 535
Patient Problem/Medical Problem 511 511
Stroke/CVA 479 479
Chest Pain 422 422
Reocclusion 403 403
Injury 382 382
No Code Available 316 316
Cardiac Arrest 313 313
Blood Loss 305 305
Insufficient Information 297 297
Thrombosis/Thrombus 281 281
Dyspnea 266 266
Obstruction/Occlusion 216 216
Cardiac Enzyme Elevation 195 195
Foreign Body In Patient 186 186
Low Blood Pressure/ Hypotension 177 177
Unspecified Tissue Injury 161 161
Device Embedded In Tissue or Plaque 154 154
Ischemia 152 152
Perforation 136 136
Non specific EKG/ECG Changes 121 121
ST Segment Elevation 120 120
Heart Failure 119 120
Hemorrhage/Bleeding 119 119
Cardiogenic Shock 92 92
Ventricular Fibrillation 88 88
Vessel Or Plaque, Device Embedded In 88 88
Embolism 86 86
Arrhythmia 84 84
Restenosis 84 84
Bradycardia 81 81
High Blood Pressure/ Hypertension 80 80
Hypersensitivity/Allergic reaction 79 79
Reaction 68 68
Prolapse 62 62
Ventricular Tachycardia 60 60
Respiratory Failure 53 53
Atrial Fibrillation 53 53
Perforation of Vessels 51 51
Nausea 43 43
Congestive Heart Failure 42 42
Aneurysm 41 41
Cardiac Tamponade 40 40
Hematoma 39 39
Pain 36 36
Pneumonia 35 35
Fatigue 35 35
No Information 33 33
Unspecified Infection 32 32
Renal Failure 30 31
Diaphoresis 30 30
Tachycardia 28 28
Cardiopulmonary Arrest 27 27
Complaint, Ill-Defined 26 26
Pericardial Effusion 26 26
Heart Failure/Congestive Heart Failure 25 25
Dizziness 25 25
Syncope 24 24
Arteriosclerosis/ Atherosclerosis 24 24
Sudden Cardiac Death 23 23
Pseudoaneurysm 23 23
Atherosclerosis 23 23
Vasoconstriction 23 23
Sepsis 22 22
Pulmonary Edema 22 22
Rash 22 22
Cardiomyopathy 21 21
Rupture 20 20
Chest Tightness/Pressure 20 20
Test Result 20 20
Respiratory Distress 19 20
Local Reaction 17 17
Shock 14 14
Anemia 14 14
Hypoxia 14 14
Inflammation 13 13
Weakness 13 13
Embolism/Embolus 13 13
Ischemic Heart Disease 12 12
ST Segment Depression 12 12
Calcium Deposits/Calcification 11 11
Failure of Implant 10 10
Edema 10 10
Transient Ischemic Attack 10 10
Neurological Deficit/Dysfunction 10 10
Vomiting 9 9
Headache 9 9
Atrial Flutter 9 9

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