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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)
2019 2020 2021 2022 2023 2024
11 7 13 17 14 10

MDR Year MDR Reports MDR Events
2019 181 181
2020 163 163
2021 201 201
2022 172 172
2023 172 172
2024 131 131

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 324 324
Activation, Positioning or Separation Problem 109 109
Difficult or Delayed Positioning 105 105
Material Deformation 83 83
Activation Failure 55 55
Difficult to Advance 54 54
Premature Activation 53 53
Difficult to Remove 53 53
Break 51 51
Detachment of Device or Device Component 47 47
Positioning Failure 44 44
Material Separation 44 44
Entrapment of Device 24 24
Fracture 24 24
Failure to Advance 22 22
Malposition of Device 21 21
Mechanical Jam 20 20
Mechanical Problem 20 20
Migration 12 12
Physical Resistance/Sticking 12 12
Positioning Problem 12 12
Defective Device 12 12
Deformation Due to Compressive Stress 10 10
Device Dislodged or Dislocated 9 9
Material Integrity Problem 9 9
Material Split, Cut or Torn 9 9
Patient-Device Incompatibility 8 8
Device Contamination with Chemical or Other Material 7 7
Difficult or Delayed Activation 7 7
Migration or Expulsion of Device 7 7
Crack 6 6
Improper or Incorrect Procedure or Method 6 6
Difficult to Insert 6 6
Device-Device Incompatibility 6 6
Material Frayed 5 5
Loss of or Failure to Bond 4 4
Leak/Splash 4 4
Off-Label Use 4 4
Use of Device Problem 4 4
Tear, Rip or Hole in Device Packaging 3 3
Unsealed Device Packaging 3 3
Difficult to Open or Remove Packaging Material 3 3
Appropriate Term/Code Not Available 3 3
Unclear Information 2 2
Activation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 2 2
Device Markings/Labelling Problem 2 2
Device Damaged by Another Device 2 2
Peeled/Delaminated 2 2
Contamination 2 2
Difficult to Flush 2 2
Obstruction of Flow 2 2
Loose or Intermittent Connection 2 2
Device Difficult to Setup or Prepare 2 2
Material Puncture/Hole 1 1
Retraction Problem 1 1
Defective Component 1 1
Stretched 1 1
Collapse 1 1
Accessory Incompatible 1 1
Partial Blockage 1 1
Ambient Temperature Problem 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Unintended Movement 1 1
Material Twisted/Bent 1 1
Difficult to Open or Close 1 1
Inaccurate Information 1 1
Patient Device Interaction Problem 1 1
Poor Visibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 416 416
No Consequences Or Impact To Patient 180 180
Thrombosis/Thrombus 120 120
Stroke/CVA 97 97
Ischemia Stroke 73 73
Transient Ischemic Attack 41 41
Stenosis 36 36
Patient Problem/Medical Problem 36 36
Vascular Dissection 30 30
Obstruction/Occlusion 29 29
Myocardial Infarction 28 28
Low Blood Pressure/ Hypotension 24 24
Restenosis 24 24
Thrombosis 21 21
No Patient Involvement 19 19
Insufficient Information 17 17
Hematoma 17 17
Brain Injury 16 16
Foreign Body In Patient 16 16
Bradycardia 15 15
Occlusion 14 14
Pain 13 13
No Known Impact Or Consequence To Patient 13 13
Intracranial Hemorrhage 11 11
Thrombus 10 10
Dysphasia 9 9
Embolism/Embolus 9 9
Unspecified Tissue Injury 9 9
Blood Loss 8 8
Muscle Weakness 8 8
Death 8 8
Embolism 8 8
Arrhythmia 7 7
Renal Failure 7 7
High Blood Pressure/ Hypertension 6 6
Hemorrhage/Bleeding 6 6
Vasoconstriction 5 5
Dizziness 5 5
Device Embedded In Tissue or Plaque 5 5
Speech Disorder 4 4
Nervous System Injury 4 4
Swelling/ Edema 4 4
Neurological Deficit/Dysfunction 4 4
Perforation of Vessels 4 4
Paresis 4 4
Reocclusion 4 4
Ischemia 4 4
Extravasation 4 4
Cardiac Arrest 3 3
Aneurysm 3 3
Unspecified Infection 3 3
Headache 3 3
Paralysis 3 3
Perforation 3 3
Seizures 3 3
Injury 3 3
Rupture 3 3
Neck Pain 3 3
Prolapse 3 3
Unspecified Nervous System Problem 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pseudoaneurysm 3 3
Hemorrhagic Stroke 3 3
Convulsion/Seizure 3 3
No Information 2 2
Thromboembolism 2 2
Confusion/ Disorientation 2 2
Loss of consciousness 2 2
Visual Impairment 2 2
Loss of Vision 2 2
Tissue Damage 2 2
Weakness 2 2
Air Embolism 2 2
Hypersensitivity/Allergic reaction 2 2
Inflammation 2 2
Nerve Damage 2 2
Infarction, Cerebral 2 2
Chest Pain 2 2
Purulent Discharge 1 1
Fatigue 1 1
Fever 1 1
Fistula 1 1
Angina 1 1
Vessel Or Plaque, Device Embedded In 1 1
Pulmonary Embolism 1 1
Syncope 1 1
Atrial Flutter 1 1
Itching Sensation 1 1
Hypoxia 1 1
Failure of Implant 1 1
Hemorrhage, Cerebral 1 1
Great Vessel Perforation 1 1
Visual Disturbances 1 1
Sepsis 1 1
Rash 1 1
Numbness 1 1
Coma 1 1
Heart Failure 1 1
Abdominal Distention 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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