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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, carotid
Definition Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
Product CodeNIM
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
12 14 17 23 14 2 11 11 8 12 11 7 13 17 14 6

MDR Year MDR Reports MDR Events
2014 201 201
2015 127 127
2016 121 121
2017 133 133
2018 103 103
2019 181 181
2020 163 163
2021 201 201
2022 172 172
2023 172 172
2024 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 506 506
Activation, Positioning or Separation Problem 165 165
Difficult or Delayed Positioning 163 163
Material Deformation 98 98
Premature Activation 85 85
Difficult to Remove 85 85
Positioning Failure 84 84
Break 72 72
Difficult to Advance 60 60
Activation Failure 56 56
Detachment Of Device Component 52 52
Detachment of Device or Device Component 52 52
Material Separation 49 49
Failure to Advance 37 37
Fracture 35 35
Entrapment of Device 33 33
Malposition of Device 21 21
Device Dislodged or Dislocated 21 21
Improper or Incorrect Procedure or Method 20 20
Bent 20 20
Crack 19 19
Mechanical Jam 19 19
Mechanical Problem 18 18
Migration or Expulsion of Device 17 17
Inaccurate Delivery 17 17
Device Damaged Prior to Use 15 15
Positioning Problem 14 14
Migration 13 13
Difficult To Position 12 12
Physical Resistance 11 11
Defective Device 11 11
Device Damaged by Another Device 11 11
Material Split, Cut or Torn 11 11
Physical Resistance/Sticking 11 11
Deformation Due to Compressive Stress 10 10
Retraction Problem 10 10
Occlusion Within Device 10 10
Material Frayed 10 10
Difficult to Insert 10 10
Device Expiration Issue 9 9
Device Contamination with Chemical or Other Material 9 9
Material Integrity Problem 9 9
Device-Device Incompatibility 7 7
Patient-Device Incompatibility 6 6
Difficult or Delayed Activation 6 6
Leak/Splash 6 6
Unsealed Device Packaging 5 5
Off-Label Use 5 5
Kinked 5 5
Tear, Rip or Hole in Device Packaging 5 5
Device Operates Differently Than Expected 5 5
Use of Device Problem 4 4
Obstruction of Flow 4 4
Partial Blockage 4 4
Loss of or Failure to Bond 4 4
Torn Material 4 4
Insufficient Information 4 4
Material Twisted/Bent 3 3
Difficult to Open or Remove Packaging Material 3 3
Difficult to Flush 3 3
Device Difficult to Setup or Prepare 3 3
Defective Component 3 3
Component Missing 3 3
Inadequacy of Device Shape and/or Size 3 3
Component or Accessory Incompatibility 3 3
Device Markings/Labelling Problem 2 2
Device Packaging Compromised 2 2
Loose or Intermittent Connection 2 2
Contamination 2 2
Failure To Adhere Or Bond 2 2
Collapse 2 2
Therapeutic or Diagnostic Output Failure 2 2
Activation Problem 2 2
Poor Visibility 1 1
Material Too Soft/Flexible 1 1
Physical Property Issue 1 1
Patient Device Interaction Problem 1 1
Difficult to Open or Close 1 1
Material Distortion 1 1
Accessory Incompatible 1 1
Failure to Capture 1 1
Premature Discharge of Battery 1 1
Material Puncture/Hole 1 1
Therapy Delivered to Incorrect Body Area 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Ambient Temperature Problem 1 1
Capturing Problem 1 1
Sticking 1 1
Stretched 1 1
Shelf Life Exceeded 1 1
Folded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 531 531
No Clinical Signs, Symptoms or Conditions 373 373
Stroke/CVA 150 150
Thrombosis/Thrombus 100 100
Stenosis 82 82
Transient Ischemic Attack 70 70
No Patient Involvement 67 67
Ischemia Stroke 61 61
Thrombosis 56 56
Patient Problem/Medical Problem 51 51
Low Blood Pressure/ Hypotension 44 44
Death 41 41
Myocardial Infarction 33 33
Vascular Dissection 33 33
Infarction, Cerebral 29 29
No Known Impact Or Consequence To Patient 27 27
Obstruction/Occlusion 26 26
Occlusion 25 25
Bradycardia 23 23
Restenosis 22 22
Foreign Body In Patient 20 20
Embolism 18 18
Hematoma 17 17
Neurological Deficit/Dysfunction 17 17
Brain Injury 17 17
Insufficient Information 17 17
Pain 15 15
Thrombus 14 14
Reocclusion 14 14
Intracranial Hemorrhage 12 12
Vasoconstriction 11 11
Weakness 10 10
Hemorrhage/Bleeding 10 10
Device Embedded In Tissue or Plaque 10 10
Vascular System (Circulation), Impaired 10 10
Unspecified Tissue Injury 9 9
Blood Loss 8 8
Embolism/Embolus 8 8
High Blood Pressure/ Hypertension 7 7
Intimal Dissection 7 7
Perforation of Vessels 7 7
Renal Failure 7 7
Paresis 7 7
Seizures 6 6
Dysphasia 6 6
Arrhythmia 6 6
Headache 6 6
Cardiac Arrest 5 5
Dizziness 5 5
No Information 5 5
No Code Available 5 5
Pseudoaneurysm 4 4
Visual Disturbances 4 4
Ischemia 4 4
Aneurysm 4 4
Extravasation 4 4
Hemorrhage, Cerebral 4 4
Syncope 3 3
Unspecified Infection 3 3
Perforation 3 3
Paralysis 3 3
Visual Impairment 3 3
Injury 3 3
Rupture 3 3
Thromboembolism 3 3
Nervous System Injury 3 3
Neck Pain 3 3
Prolapse 3 3
Unspecified Nervous System Problem 3 3
Convulsion/Seizure 3 3
Hemorrhagic Stroke 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Swelling/ Edema 2 2
Speech Disorder 2 2
Numbness 2 2
Loss of Vision 2 2
Tissue Damage 2 2
Inflammation 2 2
Nerve Damage 2 2
Air Embolism 2 2
Pulmonary Embolism 2 2
Chest Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Vessel Or Plaque, Device Embedded In 2 2
Hypoxia 1 1
Fever 1 1
Fistula 1 1
Hearing Impairment 1 1
Embolus 1 1
Purulent Discharge 1 1
Cardiopulmonary Arrest 1 1
Angina 1 1
Calcium Deposits/Calcification 1 1
Atrial Fibrillation 1 1
Atrial Flutter 1 1
Atrial Tachycardia 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Sepsis 1 1
Rash 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Nov-10-2010
2 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Mar-16-2010
3 Abbott Vascular-Cardiac Therapies dba Guidant Corporation II Jan-29-2010
4 Cardinal Health Inc. II Dec-20-2019
5 Cordis Corporation I Mar-15-2021
6 Cordis Corporation II Jun-10-2016
7 Ev3, Inc. II Dec-29-2014
8 Silk Road Medical Inc II Feb-23-2021
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