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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)
2016 2017 2018 2019 2020 2021
11 8 12 11 7 8

MDR Year MDR Reports MDR Events
2016 121 121
2017 133 133
2018 103 103
2019 181 181
2020 163 163
2021 154 154

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 222 222
Difficult or Delayed Positioning 90 90
Activation, Positioning or SeparationProblem 87 87
Material Deformation 57 57
Difficult to Remove 42 42
Premature Activation 41 41
Break 38 38
Material Separation 38 38
Detachment of Device or Device Component 38 38
Activation Failure 36 36
Detachment Of Device Component 32 32
Difficult to Advance 27 27
Positioning Failure 26 26
Fracture 21 21
Failure to Advance 18 18
Entrapment of Device 18 18
Crack 13 13
Device Dislodged or Dislocated 13 13
Migration or Expulsion of Device 12 12
Improper or Incorrect Procedure or Method 12 12
Malposition of Device 12 12
Inaccurate Delivery 11 11
Positioning Problem 10 10
Device Damaged Prior to Use 10 10
Device Damaged by Another Device 9 9
Bent 9 9
Deformation Due to Compressive Stress 8 8
Mechanical Jam 8 8
Retraction Problem 7 7
Difficult To Position 7 7
Device Expiration Issue 6 6
Physical Resistance 6 6
Material Split, Cut or Torn 6 6
Material Frayed 6 6
Migration 6 6
Difficult to Insert 5 5
Mechanical Problem 5 5
Loss of or Failure to Bond 4 4
Off-Label Use 4 4
Leak/Splash 4 4
Physical Resistance/Sticking 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Integrity Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Occlusion Within Device 3 3
Partial Blockage 3 3
Unsealed Device Packaging 3 3
Defective Device 3 3
Patient-Device Incompatibility 3 3
Obstruction of Flow 3 3
Material Twisted/Bent 3 3
Difficult to Open or Remove Packaging Material 3 3
Insufficient Information 3 3
Torn Material 2 2
Activation Problem 2 2
Use of Device Problem 2 2
Component Missing 2 2
Device Packaging Compromised 2 2
Inadequacy of Device Shape and/or Size 2 2
Difficult or Delayed Activation 2 2
Device Markings/Labelling Problem 2 2
Device-Device Incompatibility 2 2
Ambient Temperature Problem 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Distortion 1 1
Defective Component 1 1
Contamination 1 1
Failure to Capture 1 1
Accessory Incompatible 1 1
Failure To Adhere Or Bond 1 1
Premature Discharge of Battery 1 1
Kinked 1 1
Device Operates Differently Than Expected 1 1
Capturing Problem 1 1
Component or Accessory Incompatibility 1 1
Shelf Life Exceeded 1 1
Stretched 1 1
Material Puncture/Hole 1 1
Device Difficult to Setup or Prepare 1 1
Collapse 1 1
Difficult to Flush 1 1
Patient Device Interaction Problem 1 1
Material Too Soft/Flexible 1 1
Physical Property Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 394 394
No Clinical Signs, Symptoms or Conditions 93 93
Stroke/CVA 81 81
Patient Problem/Medical Problem 51 51
No Patient Involvement 47 47
Thrombosis 41 41
Transient Ischemic Attack 31 31
Thrombosis/Thrombus 29 29
Stenosis 28 28
Death 25 25
No Known Impact Or Consequence To Patient 21 21
Occlusion 21 21
Myocardial Infarction 20 20
Brain Injury 17 17
Vascular Dissection 17 17
Low Blood Pressure/ Hypotension 16 16
Embolism 15 15
Thrombus 14 14
Pain 12 12
Foreign Body In Patient 11 11
Bradycardia 10 10
Hematoma 10 10
Blood Loss 8 8
Device Embedded In Tissue or Plaque 8 8
Obstruction/Occlusion 7 7
Hemorrhage/Bleeding 7 7
Renal Failure 7 7
Neurological Deficit/Dysfunction 7 7
Insufficient Information 7 7
Restenosis 6 6
Arrhythmia 5 5
Intimal Dissection 5 5
Infarction, Cerebral 5 5
Reocclusion 5 5
Seizures 5 5
Weakness 5 5
Vasoconstriction 5 5
Intracranial Hemorrhage 5 5
High Blood Pressure/ Hypertension 4 4
Paresis 4 4
Perforation of Vessels 4 4
Pseudoaneurysm 4 4
Ischemia Stroke 4 4
Unspecified Tissue Injury 3 3
No Information 3 3
Thromboembolism 3 3
Injury 3 3
Cardiac Arrest 3 3
Headache 3 3
Unspecified Infection 3 3
Rupture 3 3
Perforation 3 3
Hemorrhage, Cerebral 3 3
Extravasation 3 3
Aneurysm 3 3
Prolapse 3 3
Convulsion/Seizure 3 3
Vessel Or Plaque, Device Embedded In 2 2
Pulmonary Embolism 2 2
Inflammation 2 2
Ischemia 2 2
Neck Pain 2 2
Visual Disturbances 2 2
Syncope 2 2
Chest Pain 2 2
Dizziness 2 2
Tissue Damage 2 2
Paralysis 2 2
Heart Failure 1 1
Great Vessel Perforation 1 1
Convulsion, Clonic 1 1
Purulent Discharge 1 1
Angina 1 1
Nerve Damage 1 1
Embolus 1 1
Fistula 1 1
Nervous System Injury 1 1
No Code Available 1 1
Not Applicable 1 1
Unspecified Nervous System Problem 1 1
Sepsis 1 1
Cerebral Hyperperfusion Syndrome 1 1
Numbness 1 1
Coma 1 1
Muscle Weakness 1 1
Air Embolism 1 1
Atrial Flutter 1 1
Fever 1 1
Hearing Impairment 1 1
Embolism/Embolus 1 1
Retroperitoneal Hemorrhage 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not 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 Cordis Corporation II Jun-10-2016
4 Silk Road Medical Inc II Feb-23-2021
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