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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
88 82 97 167 99 128 45 72 53 61 59 62 63 45 49 9

MDR Year MDR Reports MDR Events
2014 6664 6664
2015 6142 6142
2016 7233 7233
2017 6786 6786
2018 6817 6817
2019 7254 7254
2020 6362 6362
2021 5268 5268
2022 4068 4153
2023 3096 3096
2024 839 839

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18318 18318
Material Deformation 11192 11192
Failure to Advance 10912 10912
Device Dislodged or Dislocated 7408 7408
Bent 5450 5450
Difficult to Remove 3680 3680
Break 2813 2813
Occlusion Within Device 2281 2281
Difficult to Advance 1266 1266
Improper or Incorrect Procedure or Method 1203 1203
Device Damaged Prior to Use 1146 1146
Detachment Of Device Component 1075 1075
Device Damaged by Another Device 1036 1036
Inflation Problem 835 835
Material Rupture 790 790
Fracture 719 719
Activation, Positioning or Separation Problem 715 715
Leak/Splash 497 497
Deflation Problem 490 490
Difficult To Position 481 481
Material Separation 471 471
Kinked 455 455
Detachment of Device or Device Component 431 431
Entrapment of Device 422 422
Activation Failure 390 390
Obstruction of Flow 361 361
Difficult or Delayed Positioning 300 300
Burst Container or Vessel 244 244
Positioning Problem 231 231
Positioning Failure 215 215
Migration or Expulsion of Device 215 215
Physical Resistance 207 207
Defective Device 167 167
Patient-Device Incompatibility 162 247
Device-Device Incompatibility 138 138
Device Expiration Issue 137 137
Material Integrity Problem 131 131
Deformation Due to Compressive Stress 126 126
Stretched 124 124
Material Twisted/Bent 115 115
Unstable 108 108
Difficult to Insert 106 106
Migration 106 106
Use of Device Problem 103 103
Malposition of Device 92 92
Device Contamination with Chemical or Other Material 90 90
Torn Material 87 87
Material Split, Cut or Torn 85 85
Physical Resistance/Sticking 84 84
Device Markings/Labelling Problem 80 80
Insufficient Information 79 79
Difficult or Delayed Activation 67 67
Device Operates Differently Than Expected 62 62
Premature Activation 55 55
Off-Label Use 51 51
Patient Device Interaction Problem 51 51
Failure to Deflate 47 47
Component Missing 46 46
Product Quality Problem 36 36
Contamination 36 36
Tear, Rip or Hole in Device Packaging 35 35
Unsealed Device Packaging 32 32
Defective Component 31 31
Unintended Movement 25 25
Unintended System Motion 24 24
Inadequacy of Device Shape and/or Size 24 24
Difficult to Open or Remove Packaging Material 23 23
Appropriate Term/Code Not Available 22 22
Device Or Device Fragments Location Unknown 22 22
Material Puncture/Hole 22 22
Collapse 22 22
Hole In Material 21 21
Peeled/Delaminated 21 21
Packaging Problem 21 21
Contamination /Decontamination Problem 19 19
Device Misassembled During Manufacturing /Shipping 19 19
Crack 19 19
Folded 17 17
No Apparent Adverse Event 17 17
Device Slipped 16 16
Fluid/Blood Leak 15 15
Material Protrusion/Extrusion 14 14
Material Distortion 14 14
Failure To Adhere Or Bond 13 13
Retraction Problem 13 13
Loose or Intermittent Connection 13 13
Material Too Soft/Flexible 13 13
Physical Property Issue 12 12
Device Packaging Compromised 11 11
Failure to Fold 11 11
Sticking 10 10
Inaccurate Delivery 9 9
Wrong Label 9 9
Mechanical Jam 8 8
Mechanical Problem 8 8
Material Too Rigid or Stiff 7 7
Material Frayed 7 7
Device Difficult to Setup or Prepare 6 6
Expiration Date Error 6 6
Component Misassembled 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 24712 24713
No Clinical Signs, Symptoms or Conditions 8551 8551
Myocardial Infarction 4231 4317
Intimal Dissection 3877 3877
Death 3278 3278
Angina 2723 2723
No Patient Involvement 2663 2663
Vascular Dissection 2603 2603
Thrombosis 2447 2447
Reocclusion 1475 1475
Stenosis 1446 1446
Chest Pain 1253 1253
No Known Impact Or Consequence To Patient 1096 1098
Occlusion 1073 1073
Insufficient Information 889 889
Thrombus 696 696
Dyspnea 685 685
Stroke/CVA 684 769
Cardiac Arrest 674 674
Patient Problem/Medical Problem 659 659
Thrombosis/Thrombus 623 708
Cardiac Enzyme Elevation 609 609
Obstruction/Occlusion 526 526
Foreign Body In Patient 444 444
Blood Loss 413 413
Device Embedded In Tissue or Plaque 390 390
Injury 389 389
No Code Available 381 381
Non specific EKG/ECG Changes 374 374
Ischemia 362 362
Low Blood Pressure/ Hypotension 358 358
ST Segment Elevation 297 297
Restenosis 269 269
Perforation 257 257
Hypersensitivity/Allergic reaction 212 212
Ventricular Fibrillation 191 191
Bradycardia 191 191
Heart Failure 183 184
Hemorrhage/Bleeding 178 178
Cardiogenic Shock 175 175
Unspecified Tissue Injury 169 169
Arrhythmia 168 168
Vessel Or Plaque, Device Embedded In 162 162
Nausea 158 158
Perforation of Vessels 147 147
High Blood Pressure/ Hypertension 132 132
Reaction 130 130
Pain 125 125
Congestive Heart Failure 119 119
Ventricular Tachycardia 117 117
Respiratory Failure 114 114
Prolapse 113 113
Embolism 107 107
Atrial Fibrillation 102 102
Diaphoresis 96 96
Aneurysm 93 93
No Information 88 88
Chest Tightness/Pressure 81 81
Heart Failure/Congestive Heart Failure 75 75
Cardiac Tamponade 74 74
Fatigue 74 74
Arteriosclerosis/ Atherosclerosis 73 73
Hematoma 72 72
Cardiopulmonary Arrest 65 65
Vasoconstriction 62 62
Dizziness 59 59
Renal Failure 58 59
Pneumonia 53 53
Rash 52 52
Test Result 52 52
Atherosclerosis 51 51
Pulmonary Edema 47 47
Respiratory Distress 45 46
Cardiomyopathy 45 45
Syncope 44 44
Pericardial Effusion 44 44
Unspecified Infection 43 43
Weakness 42 42
Vomiting 41 41
Tachycardia 40 40
Local Reaction 38 38
Sepsis 35 35
Shock 35 35
Loss Of Pulse 33 33
Discomfort 32 32
Complaint, Ill-Defined 31 31
Rupture 31 31
Embolism/Embolus 31 31
Ischemic Heart Disease 30 30
Fever 30 30
Pseudoaneurysm 29 29
Anemia 27 27
Headache 26 26
Sudden Cardiac Death 26 26
ST Segment Depression 22 22
Edema 21 21
Failure of Implant 21 21
Numbness 20 20
Sweating 19 19
Hypoxia 19 19

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Jun-15-2020
2 Medtronic Vascular Galway Limited II Aug-21-2009
3 Medtronic Vascular, Inc. II Nov-05-2013
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