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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 6

MDR Year MDR Reports MDR Events
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 293 293
Activation, Positioning or Separation Problem 105 105
Difficult or Delayed Positioning 95 95
Material Deformation 75 75
Difficult to Advance 53 53
Activation Failure 51 51
Break 50 50
Difficult to Remove 49 49
Premature Activation 48 48
Detachment of Device or Device Component 47 47
Positioning Failure 44 44
Material Separation 43 43
Fracture 23 23
Entrapment of Device 22 22
Malposition of Device 20 20
Failure to Advance 20 20
Mechanical Jam 19 19
Mechanical Problem 18 18
Positioning Problem 12 12
Defective Device 11 11
Migration 11 11
Deformation Due to Compressive Stress 10 10
Physical Resistance/Sticking 10 10
Device Dislodged or Dislocated 9 9
Material Split, Cut or Torn 9 9
Material Integrity Problem 8 8
Migration or Expulsion of Device 7 7
Device Contamination with Chemical or Other Material 7 7
Difficult to Insert 6 6
Difficult or Delayed Activation 6 6
Crack 5 5
Device-Device Incompatibility 5 5
Patient-Device Incompatibility 5 5
Improper or Incorrect Procedure or Method 5 5
Material Frayed 5 5
Loss of or Failure to Bond 4 4
Use of Device Problem 4 4
Leak/Splash 4 4
Off-Label Use 4 4
Unsealed Device Packaging 3 3
Difficult to Open or Remove Packaging Material 3 3
Tear, Rip or Hole in Device Packaging 3 3
Contamination 2 2
Device Difficult to Setup or Prepare 2 2
Component Missing 2 2
Therapeutic or Diagnostic Output Failure 2 2
Activation Problem 2 2
Difficult to Flush 2 2
Obstruction of Flow 2 2
Loose or Intermittent Connection 2 2
Device Markings/Labelling Problem 2 2
Device Damaged by Another Device 2 2
Patient Device Interaction Problem 1 1
Partial Blockage 1 1
Accessory Incompatible 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Collapse 1 1
Stretched 1 1
Material Puncture/Hole 1 1
Difficult to Open or Close 1 1
Retraction Problem 1 1
Poor Visibility 1 1
Ambient Temperature Problem 1 1
Compatibility Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 373 373
No Consequences Or Impact To Patient 180 180
Thrombosis/Thrombus 100 100
Stroke/CVA 92 92
Ischemia Stroke 61 61
Transient Ischemic Attack 38 38
Patient Problem/Medical Problem 36 36
Stenosis 34 34
Vascular Dissection 29 29
Myocardial Infarction 28 28
Obstruction/Occlusion 26 26
Restenosis 22 22
Thrombosis 21 21
No Patient Involvement 19 19
Low Blood Pressure/ Hypotension 19 19
Insufficient Information 17 17
Hematoma 16 16
Brain Injury 16 16
Occlusion 14 14
Bradycardia 14 14
Foreign Body In Patient 13 13
No Known Impact Or Consequence To Patient 13 13
Pain 11 11
Thrombus 10 10
Intracranial Hemorrhage 10 10
Unspecified Tissue Injury 9 9
Embolism/Embolus 8 8
Death 8 8
Embolism 8 8
Blood Loss 8 8
Renal Failure 7 7
Arrhythmia 6 6
High Blood Pressure/ Hypertension 6 6
Hemorrhage/Bleeding 5 5
Dysphasia 5 5
Device Embedded In Tissue or Plaque 5 5
Dizziness 4 4
Paresis 4 4
Reocclusion 4 4
Vasoconstriction 4 4
Perforation of Vessels 4 4
Neurological Deficit/Dysfunction 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
Pseudoaneurysm 3 3
Nervous System Injury 3 3
Hemorrhagic Stroke 3 3
Convulsion/Seizure 3 3
Unspecified Nervous System Problem 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Swelling/ Edema 2 2
Speech Disorder 2 2
No Information 2 2
Prolapse 2 2
Thromboembolism 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
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
Muscle Weakness 1 1
Hypoxia 1 1
Hemorrhage, Cerebral 1 1
Great Vessel Perforation 1 1
Visual Disturbances 1 1
Sepsis 1 1
Rash 1 1
Abdominal Distention 1 1
Numbness 1 1
Coma 1 1
Loss of consciousness 1 1
Heart Failure 1 1
No Code Available 1 1
Cerebral Hyperperfusion Syndrome 1 1
Retroperitoneal Hemorrhage 1 1
Cramp(s) /Muscle Spasm(s) 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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