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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)
2016 2017 2018 2019 2020 2021
72 53 61 59 62 11

MDR Year MDR Reports MDR Events
2016 7233 7233
2017 6786 6786
2018 6816 6816
2019 7254 7254
2020 6362 6362
2021 976 976

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10777 10777
Material Deformation 6807 6807
Stent 5685 5685
Failure to Advance 5301 5301
Device Dislodged or Dislocated 4333 4333
Bent 3554 3554
Catheter 2415 2415
Difficult to Remove 1698 1698
Break 1546 1546
Occlusion Within Device 1170 1170
Device Damaged Prior to Use 895 895
Shaft 785 785
Difficult to Advance 631 631
Device Damaged by Another Device 626 626
Improper or Incorrect Procedure or Method 545 545
Inflation Problem 418 418
Activation, Positioning or SeparationProblem 399 399
Fracture 377 377
Material Rupture 371 371
Detachment Of Device Component 368 368
Material Separation 281 281
Deflation Problem 270 270
Balloon 244 244
Leak/Splash 232 232
Entrapment of Device 226 226
Difficult To Position 225 225
Obstruction of Flow 221 221
Detachment of Device or Device Component 217 217
Kinked 189 189
Activation Failure 169 169
Difficult or Delayed Positioning 130 130
Burst Container or Vessel 123 123
Migration or Expulsion of Device 109 109
Patient-Device Incompatibility 103 103
Positioning Failure 102 102
Material Twisted/Bent 101 101
Physical Resistance 93 93
Defective Device 90 90
Migration 69 69
Physical Resistance/Sticking 68 68
Stretched 68 68
Deformation Due to Compressive Stress 65 65
Malposition of Device 65 65
Material Integrity Problem 64 64
Device Expiration Issue 63 63
Unstable 59 59
Insufficient Information 55 55
Device-Device Incompatibility 50 50
Device Contamination with Chemical or Other Material 49 49
Use of Device Problem 47 47
Positioning Problem 46 46
Difficult to Insert 46 46
Device Markings/Labelling Problem 40 40
Torn Material 37 37
Device Operates Differently Than Expected 34 34
Difficult or Delayed Activation 33 33
Component Missing 30 30
Tip 29 29
Premature Activation 28 28
Tear, Rip or Hole in Device Packaging 26 26
Material Split, Cut or Torn 24 24
Patient Device Interaction Problem 22 22
Product Quality Problem 19 19
Appropriate Term/Code Not Available 18 18
Off-Label Use 18 18
Device Or Device Fragments Location Unknown 17 17
Defective Component 17 17
Inadequacy of Device Shape and/or Size 16 16
Contamination 16 16
Contamination /Decontamination Problem 15 15
Device Misassembled During Manufacturing /Shipping 15 15
Crack 14 14
Unsealed Device Packaging 13 13
Unintended System Motion 13 13
Physical Property Issue 11 11
Hole In Material 10 10
Peeled/Delaminated 10 10
Loose or Intermittent Connection 9 9
Material Distortion 9 9
Unintended Movement 9 9
Packaging Problem 9 9
Material Protrusion/Extrusion 8 8
Device Slipped 8 8
Material Puncture/Hole 8 8
Retraction Problem 8 8
Inaccurate Delivery 7 7
Difficult to Open or Remove Packaging Material 7 7
No Apparent Adverse Event 7 7
Failure to Fold 7 7
Sticking 6 6
Label 6 6
Wire 6 6
Guidewire 6 6
Mechanical Jam 6 6
Fluid Leak 6 6
Mechanical Problem 5 5
Expulsion 5 5
Human-Device Interface Problem 5 5
Folded 5 5
Device Packaging Compromised 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 18391 18391
Myocardial Infarction 2852 2853
Intimal Dissection 2647 2647
Death 2283 2283
No Patient Involvement 1906 1906
Thrombosis 1698 1698
Angina 1542 1542
No Known Impact Or Consequence To Patient 911 911
Stenosis 847 847
No Clinical Signs, Symptoms or Conditions 796 796
Occlusion 767 767
Reocclusion 705 705
Chest Pain 665 665
Patient Problem/Medical Problem 621 621
Thrombus 586 586
Stroke/CVA 474 474
Vascular Dissection 471 471
Dyspnea 398 398
Injury 383 383
Cardiac Arrest 362 362
No Code Available 349 349
Blood Loss 328 328
Cardiac Enzyme Elevation 256 256
Obstruction/Occlusion 203 203
Low Blood Pressure/ Hypotension 202 202
Foreign Body In Patient 201 201
ST Segment Elevation 196 196
Ischemia 176 176
Device Embedded In Tissue or Plaque 176 176
Perforation 152 152
Non specific EKG/ECG Changes 141 141
Heart Failure 136 136
Ventricular Fibrillation 115 115
Vessel Or Plaque, Device Embedded In 115 115
Hypersensitivity/Allergic reaction 107 107
Cardiogenic Shock 105 105
Bradycardia 99 99
Insufficient Information 99 99
Arrhythmia 96 96
Thrombosis/Thrombus 94 94
Embolism 92 92
Hemorrhage/Bleeding 87 87
High Blood Pressure/ Hypertension 84 84
Congestive Heart Failure 84 84
Ventricular Tachycardia 84 84
Reaction 82 82
Nausea 72 72
Prolapse 70 70
Atrial Fibrillation 67 67
Respiratory Failure 62 62
Perforation of Vessels 52 52
Unspecified Tissue Injury 52 52
Pain 48 48
Fatigue 48 48
Diaphoresis 46 46
Cardiopulmonary Arrest 46 46
No Information 44 44
Dizziness 40 40
Aneurysm 40 40
Cardiac Tamponade 39 39
Hematoma 36 36
Vasoconstriction 35 35
Test Result 35 35
Pneumonia 33 33
Renal Failure 33 33
Unspecified Infection 32 32
Syncope 32 32
Atherosclerosis 27 27
Weakness 27 27
Chest Tightness/Pressure 27 27
Complaint, Ill-Defined 26 26
Respiratory Distress 26 26
Pericardial Effusion 25 25
Sudden Cardiac Death 23 23
Sepsis 23 23
Cardiomyopathy 23 23
Pulmonary Edema 23 23
Pseudoaneurysm 22 22
Rash 22 22
Tachycardia 19 19
Vomiting 19 19
Rupture 18 18
Shock 17 17
Edema 17 17
ST Segment Depression 17 17
Anemia 16 16
Loss Of Pulse 15 15
Restenosis 15 15
Headache 15 15
Inflammation 14 14
Numbness 14 14
Neurological Deficit/Dysfunction 13 13
Ischemic Heart Disease 13 13
Fever 11 11
Calcium Deposits/Calcification 10 10
Infarction, Cerebral 9 9
Discomfort 9 9
Hypoxia 9 9
Air Embolism 8 8
Atrial Flutter 8 8

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