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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)
2018 2019 2020 2021 2022 2023
12 11 7 13 17 14

MDR Year MDR Reports MDR Events
2018 103 103
2019 181 181
2020 163 163
2021 201 201
2022 172 172
2023 162 162

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 295 295
Activation, Positioning or Separation Problem 112 112
Difficult or Delayed Positioning 101 101
Material Deformation 73 73
Difficult to Advance 55 55
Activation Failure 52 52
Difficult to Remove 52 52
Material Separation 47 47
Premature Activation 47 47
Detachment of Device or Device Component 47 47
Break 46 46
Positioning Failure 40 40
Fracture 27 27
Entrapment of Device 21 21
Failure to Advance 21 21
Malposition of Device 18 18
Mechanical Jam 18 18
Mechanical Problem 16 16
Migration 13 13
Material Split, Cut or Torn 11 11
Positioning Problem 11 11
Defective Device 10 10
Device Dislodged or Dislocated 10 10
Deformation Due to Compressive Stress 10 10
Physical Resistance/Sticking 10 10
Device Contamination with Chemical or Other Material 8 8
Material Integrity Problem 8 8
Migration or Expulsion of Device 8 8
Material Frayed 8 8
Difficult to Insert 8 8
Device Damaged by Another Device 7 7
Patient-Device Incompatibility 6 6
Difficult or Delayed Activation 6 6
Detachment Of Device Component 6 6
Crack 6 6
Improper or Incorrect Procedure or Method 6 6
Retraction Problem 5 5
Off-Label Use 5 5
Unsealed Device Packaging 4 4
Use of Device Problem 4 4
Loss of or Failure to Bond 4 4
Leak/Splash 4 4
Obstruction of Flow 4 4
Device-Device Incompatibility 4 4
Tear, Rip or Hole in Device Packaging 3 3
Material Twisted/Bent 3 3
Difficult to Open or Remove Packaging Material 3 3
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 2 2
Device Markings/Labelling Problem 2 2
Loose or Intermittent Connection 2 2
Bent 2 2
Contamination 2 2
Device Damaged Prior to Use 2 2
Device Difficult to Setup or Prepare 2 2
Difficult to Flush 2 2
Activation Problem 2 2
Poor Visibility 1 1
Material Too Soft/Flexible 1 1
Occlusion Within Device 1 1
Material Puncture/Hole 1 1
Defective Component 1 1
Stretched 1 1
Failure to Capture 1 1
Collapse 1 1
Partial Blockage 1 1
Accessory Incompatible 1 1
Device Expiration Issue 1 1
Device Operates Differently Than Expected 1 1
Capturing Problem 1 1
Inaccurate Delivery 1 1
Ambient Temperature Problem 1 1
Torn Material 1 1
Insufficient Information 1 1
Patient Device Interaction Problem 1 1
Difficult to Open or Close 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 333 333
No Consequences Or Impact To Patient 239 239
Stroke/CVA 95 95
Thrombosis/Thrombus 82 82
Ischemia Stroke 49 49
Patient Problem/Medical Problem 42 42
Transient Ischemic Attack 39 39
Stenosis 36 36
Thrombosis 31 31
Vascular Dissection 30 30
Myocardial Infarction 29 29
No Patient Involvement 25 25
Obstruction/Occlusion 24 24
Low Blood Pressure/ Hypotension 22 22
Restenosis 21 21
Occlusion 18 18
Brain Injury 17 17
Bradycardia 17 17
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 15 15
Hematoma 15 15
Thrombus 14 14
Foreign Body In Patient 14 14
Pain 12 12
Embolism 11 11
Intracranial Hemorrhage 10 10
Death 10 10
Hemorrhage/Bleeding 9 9
Unspecified Tissue Injury 9 9
Blood Loss 8 8
Renal Failure 7 7
Device Embedded In Tissue or Plaque 7 7
Embolism/Embolus 6 6
High Blood Pressure/ Hypertension 6 6
Arrhythmia 6 6
Paresis 5 5
Seizures 5 5
Vasoconstriction 5 5
Dizziness 5 5
Perforation of Vessels 4 4
Neurological Deficit/Dysfunction 4 4
Reocclusion 4 4
Extravasation 4 4
Cardiac Arrest 4 4
Headache 4 4
Ischemia 4 4
Unspecified Infection 3 3
Hemorrhage, Cerebral 3 3
Infarction, Cerebral 3 3
Aneurysm 3 3
Perforation 3 3
Paralysis 3 3
Dysphasia 3 3
Weakness 3 3
Neck Pain 3 3
Prolapse 3 3
Injury 3 3
Hemorrhagic Stroke 3 3
Unspecified Nervous System Problem 3 3
Convulsion/Seizure 3 3
Nervous System Injury 3 3
Rupture 3 3
Pseudoaneurysm 3 3
Thromboembolism 2 2
No Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Swelling/ Edema 2 2
Visual Impairment 2 2
Loss of Vision 2 2
Tissue Damage 2 2
Intimal Dissection 2 2
Pulmonary Embolism 2 2
Syncope 2 2
Air Embolism 2 2
Chest Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Inflammation 2 2
Nerve Damage 2 2
Itching Sensation 1 1
Muscle Weakness 1 1
Hypoxia 1 1
Vessel Or Plaque, Device Embedded In 1 1
Purulent Discharge 1 1
Fever 1 1
Fistula 1 1
Angina 1 1
Atrial Flutter 1 1
Sepsis 1 1
Visual Disturbances 1 1
Rash 1 1
Numbness 1 1
Coma 1 1
Loss of consciousness 1 1
Abdominal Distention 1 1
Great Vessel Perforation 1 1
Convulsion, Clonic 1 1
Heart Failure 1 1
Retroperitoneal Hemorrhage 1 1
Cramp(s) /Muscle Spasm(s) 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Dec-20-2019
2 Cordis Corporation I Mar-15-2021
3 Silk Road Medical Inc II Feb-23-2021
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