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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)
2019 2020 2021 2022 2023 2024
59 62 63 45 49 12

MDR Year MDR Reports MDR Events
2019 7254 7254
2020 6362 6362
2021 5268 5268
2022 4068 4153
2023 3096 3096
2024 1088 1088

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8816 8816
Material Deformation 7833 7833
Failure to Advance 5086 5086
Device Dislodged or Dislocated 3369 3369
Difficult to Remove 1741 1741
Break 1552 1552
Difficult to Advance 1060 1060
Improper or Incorrect Procedure or Method 450 450
Material Separation 409 409
Fracture 390 390
Inflation Problem 379 379
Material Rupture 377 377
Activation Failure 365 365
Detachment of Device or Device Component 321 321
Device Damaged by Another Device 290 290
Obstruction of Flow 258 258
Deflation Problem 245 245
Activation, Positioning or Separation Problem 229 229
Positioning Problem 226 226
Entrapment of Device 222 222
Leak/Splash 218 218
Burst Container or Vessel 155 155
Patient-Device Incompatibility 141 226
Device-Device Incompatibility 133 133
Defective Device 119 119
Material Integrity Problem 114 114
Deformation Due to Compressive Stress 101 101
Use of Device Problem 96 96
Migration 94 94
Material Split, Cut or Torn 82 82
Positioning Failure 69 69
Stretched 63 63
Difficult to Insert 62 62
Difficult or Delayed Activation 60 60
Migration or Expulsion of Device 53 53
Patient Device Interaction Problem 51 51
Failure to Deflate 48 48
Off-Label Use 45 45
Difficult or Delayed Positioning 40 40
Device Markings/Labelling Problem 38 38
Malposition of Device 35 35
Premature Activation 33 33
Physical Resistance/Sticking 33 33
Device Contamination with Chemical or Other Material 32 32
Product Quality Problem 28 28
Contamination 25 25
Component Missing 23 23
Material Puncture/Hole 20 20
Difficult to Open or Remove Packaging Material 19 19
Packaging Problem 18 18
Insufficient Information 18 18
No Apparent Adverse Event 16 16
Material Twisted/Bent 16 16
Unsealed Device Packaging 16 16
Unintended System Motion 15 15
Fluid/Blood Leak 14 14
Tear, Rip or Hole in Device Packaging 14 14
Defective Component 13 13
Material Too Soft/Flexible 12 12
Inadequacy of Device Shape and/or Size 11 11
Contamination /Decontamination Problem 9 9
Loose or Intermittent Connection 9 9
Wrong Label 9 9
Unintended Movement 7 7
Material Too Rigid or Stiff 7 7
Failure to Fold 6 6
Component Misassembled 6 6
Activation Problem 5 5
Mechanical Problem 5 5
Retraction Problem 5 5
Expiration Date Error 5 5
Structural Problem 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Unraveled Material 4 4
Mechanical Jam 4 4
Material Protrusion/Extrusion 3 3
Human-Device Interface Problem 3 3
Infusion or Flow Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Therapeutic or Diagnostic Output Failure 3 3
Appropriate Term/Code Not Available 3 3
Device Slipped 3 3
Device Damaged Prior to Use 3 3
Separation Failure 3 3
Device Difficult to Setup or Prepare 3 3
Peeled/Delaminated 3 3
Therapy Delivered to Incorrect Body Area 2 2
Difficult to Flush 2 2
Material Frayed 2 2
Material Perforation 2 2
Failure to Deliver 2 2
Failure to Unfold or Unwrap 2 2
Device Fell 2 2
Failure to Eject 2 2
Poor Visibility 2 2
Difficult or Delayed Separation 1 1
Premature Separation 1 1
Inaccurate Information 1 1
Unexpected Color 1 1
Application Program Problem: Medication Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8702 8702
No Consequences Or Impact To Patient 7510 7510
Vascular Dissection 2507 2507
Myocardial Infarction 2079 2164
Intimal Dissection 995 995
Insufficient Information 914 914
Angina 881 881
Death 803 803
Thrombosis/Thrombus 637 722
Thrombosis 540 540
Stenosis 524 524
No Patient Involvement 416 416
No Known Impact Or Consequence To Patient 392 392
Occlusion 378 378
Injury 376 376
Stroke/CVA 357 442
Obstruction/Occlusion 291 291
Restenosis 277 277
Cardiac Arrest 271 271
Chest Pain 262 262
Thrombus 243 243
No Code Available 228 228
Foreign Body In Patient 208 208
Device Embedded In Tissue or Plaque 196 196
Blood Loss 191 191
Unspecified Tissue Injury 169 169
Ischemia 156 156
Hemorrhage/Bleeding 136 136
Low Blood Pressure/ Hypotension 126 126
Perforation 117 117
Non specific EKG/ECG Changes 116 116
Dyspnea 114 114
Cardiac Enzyme Elevation 92 92
Reocclusion 77 77
Perforation of Vessels 77 77
Heart Failure/Congestive Heart Failure 76 76
Arteriosclerosis/ Atherosclerosis 72 72
Arrhythmia 66 66
Hypersensitivity/Allergic reaction 64 64
Bradycardia 62 62
Ventricular Fibrillation 61 61
Cardiogenic Shock 60 60
High Blood Pressure/ Hypertension 60 60
Prolapse 59 59
Embolism 51 51
Patient Problem/Medical Problem 50 50
Heart Failure 48 48
Pain 47 47
Aneurysm 43 43
Local Reaction 41 41
Hematoma 39 39
Vessel Or Plaque, Device Embedded In 38 38
Embolism/Embolus 33 33
Respiratory Failure 32 32
Atrial Fibrillation 32 32
Pneumonia 29 29
Cardiac Tamponade 29 29
Tachycardia 27 27
Pericardial Effusion 27 27
Ventricular Tachycardia 26 26
Reaction 25 25
Rash 24 24
Unspecified Infection 23 23
Complaint, Ill-Defined 23 23
Rupture 21 21
Atherosclerosis 20 20
ST Segment Elevation 19 19
Nausea 18 18
Failure of Implant 18 18
Ischemic Heart Disease 17 17
Pseudoaneurysm 16 16
Sepsis 16 16
Discomfort 15 15
Test Result 15 15
Atrial Flutter 15 15
Swelling/ Edema 15 15
Fatigue 14 14
Diaphoresis 14 14
Shock 14 14
Vasoconstriction 14 14
Dizziness 11 11
Transient Ischemic Attack 11 11
Fever 11 11
Cardiopulmonary Arrest 11 11
Unspecified Heart Problem 11 11
Anemia 10 10
Inflammation 10 10
Renal Failure 10 10
Pulmonary Edema 9 9
Syncope 9 9
Headache 8 8
Neurological Deficit/Dysfunction 7 7
No Information 7 7
Respiratory Arrest 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Sudden Cardiac Death 6 6
Anxiety 6 6
Respiratory Distress 6 6
Hypoxia 6 6
Hemoptysis 5 5

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