Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 10

MDR Year MDR Reports MDR Events
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 8730 8730
Material Deformation 7784 7784
Failure to Advance 5046 5046
Device Dislodged or Dislocated 3321 3321
Difficult to Remove 1728 1728
Break 1536 1536
Difficult to Advance 1050 1050
Improper or Incorrect Procedure or Method 439 439
Material Separation 404 404
Material Rupture 376 376
Fracture 375 375
Inflation Problem 373 373
Activation Failure 358 358
Detachment of Device or Device Component 310 310
Device Damaged by Another Device 285 285
Obstruction of Flow 258 258
Deflation Problem 244 244
Activation, Positioning or Separation Problem 225 225
Leak/Splash 214 214
Entrapment of Device 213 213
Positioning Problem 207 207
Burst Container or Vessel 151 151
Patient-Device Incompatibility 140 225
Device-Device Incompatibility 131 131
Defective Device 118 118
Material Integrity Problem 113 113
Deformation Due to Compressive Stress 100 100
Use of Device Problem 95 95
Migration 93 93
Material Split, Cut or Torn 80 80
Positioning Failure 69 69
Difficult to Insert 62 62
Stretched 61 61
Difficult or Delayed Activation 59 59
Migration or Expulsion of Device 52 52
Patient Device Interaction Problem 51 51
Failure to Deflate 47 47
Off-Label Use 44 44
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 27 27
Contamination 23 23
Component Missing 23 23
Material Puncture/Hole 19 19
Insufficient Information 18 18
Packaging Problem 18 18
Difficult to Open or Remove Packaging Material 18 18
Unsealed Device Packaging 16 16
No Apparent Adverse Event 16 16
Unintended System Motion 15 15
Material Twisted/Bent 15 15
Tear, Rip or Hole in Device Packaging 14 14
Defective Component 13 13
Fluid/Blood Leak 13 13
Material Too Soft/Flexible 12 12
Inadequacy of Device Shape and/or Size 11 11
Wrong Label 9 9
Loose or Intermittent Connection 9 9
Contamination /Decontamination Problem 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
Retraction Problem 5 5
Expiration Date Error 5 5
Structural Problem 4 4
Unraveled Material 4 4
Mechanical Jam 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Mechanical Problem 4 4
Device Slipped 3 3
Device Damaged Prior to Use 3 3
Device Contaminated During Manufacture or Shipping 3 3
Peeled/Delaminated 3 3
Material Protrusion/Extrusion 3 3
Separation Failure 3 3
Device Difficult to Setup or Prepare 3 3
Therapeutic or Diagnostic Output Failure 3 3
Appropriate Term/Code Not Available 3 3
Human-Device Interface Problem 3 3
Infusion or Flow Problem 3 3
Device Fell 2 2
Failure to Deliver 2 2
Failure to Eject 2 2
Difficult to Flush 2 2
Poor Visibility 2 2
Material Frayed 2 2
Therapy Delivered to Incorrect Body Area 2 2
Failure to Unfold or Unwrap 2 2
Material Perforation 2 2
Noise, Audible 1 1
Crack 1 1
Collapse 1 1
Disconnection 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8551 8551
No Consequences Or Impact To Patient 7510 7510
Vascular Dissection 2463 2463
Myocardial Infarction 2066 2151
Intimal Dissection 995 995
Insufficient Information 887 887
Angina 868 868
Death 803 803
Thrombosis/Thrombus 623 708
Thrombosis 540 540
Stenosis 521 521
No Patient Involvement 416 416
No Known Impact Or Consequence To Patient 392 392
Occlusion 378 378
Injury 376 376
Stroke/CVA 355 440
Obstruction/Occlusion 287 287
Cardiac Arrest 268 268
Restenosis 267 267
Chest Pain 254 254
Thrombus 243 243
No Code Available 228 228
Foreign Body In Patient 204 204
Blood Loss 191 191
Device Embedded In Tissue or Plaque 191 191
Unspecified Tissue Injury 169 169
Ischemia 153 153
Hemorrhage/Bleeding 134 134
Low Blood Pressure/ Hypotension 125 125
Perforation 117 117
Non specific EKG/ECG Changes 114 114
Dyspnea 110 110
Cardiac Enzyme Elevation 92 92
Reocclusion 77 77
Perforation of Vessels 75 75
Heart Failure/Congestive Heart Failure 75 75
Arteriosclerosis/ Atherosclerosis 70 70
Arrhythmia 63 63
Bradycardia 62 62
Hypersensitivity/Allergic reaction 62 62
Ventricular Fibrillation 61 61
Cardiogenic Shock 60 60
Prolapse 59 59
High Blood Pressure/ Hypertension 59 59
Embolism 51 51
Patient Problem/Medical Problem 50 50
Heart Failure 48 48
Pain 46 46
Aneurysm 43 43
Vessel Or Plaque, Device Embedded In 38 38
Local Reaction 38 38
Hematoma 38 38
Atrial Fibrillation 32 32
Respiratory Failure 32 32
Embolism/Embolus 31 31
Pneumonia 29 29
Cardiac Tamponade 28 28
Tachycardia 27 27
Ventricular Tachycardia 26 26
Pericardial Effusion 26 26
Reaction 25 25
Complaint, Ill-Defined 23 23
Rash 23 23
Unspecified Infection 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
Fatigue 14 14
Diaphoresis 14 14
Shock 14 14
Vasoconstriction 14 14
Swelling/ Edema 13 13
Unspecified Heart Problem 11 11
Dizziness 11 11
Transient Ischemic Attack 11 11
Fever 11 11
Cardiopulmonary Arrest 11 11
Inflammation 10 10
Renal Failure 10 10
Pulmonary Edema 9 9
Anemia 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
-
-