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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)
2020 2021 2022 2023 2024 2025
7 13 17 14 21 22

MDR Year MDR Reports MDR Events
2020 164 164
2021 202 202
2022 172 172
2023 172 173
2024 265 265
2025 559 559

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 450 450
Activation, Positioning or Separation Problem 175 175
Difficult to Remove 174 174
Difficult or Delayed Positioning 128 128
Material Deformation 111 111
Entrapment of Device 107 107
Activation Failure 91 91
Break 77 77
Difficult to Advance 72 72
Premature Activation 68 68
Positioning Failure 55 55
Detachment of Device or Device Component 44 44
Mechanical Problem 42 42
Material Separation 40 40
Positioning Problem 34 34
Defective Device 29 29
Fracture 29 29
Insufficient Information 26 26
Failure to Advance 24 24
Malposition of Device 20 20
Mechanical Jam 19 19
Migration 17 17
Device Markings/Labelling Problem 16 16
Device-Device Incompatibility 15 15
Material Integrity Problem 15 15
Physical Resistance/Sticking 14 14
Difficult to Insert 12 12
Patient-Device Incompatibility 12 12
Difficult to Open or Close 11 11
Peeled/Delaminated 11 11
Device Dislodged or Dislocated 10 10
Deformation Due to Compressive Stress 9 9
Migration or Expulsion of Device 8 8
Difficult or Delayed Activation 8 8
Improper or Incorrect Procedure or Method 7 7
Material Split, Cut or Torn 7 8
Unsealed Device Packaging 6 6
Device Contamination with Chemical or Other Material 6 6
Loss of or Failure to Bond 6 6
Use of Device Problem 6 6
Crack 5 5
Appropriate Term/Code Not Available 4 4
Obstruction of Flow 4 4
Material Frayed 4 5
Tear, Rip or Hole in Device Packaging 3 3
Component Missing 3 3
Contamination 3 3
Defective Component 3 3
Difficult to Open or Remove Packaging Material 3 3
Off-Label Use 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 929 930
Thrombosis/Thrombus 173 173
Stroke/CVA 136 136
Ischemia Stroke 107 107
No Consequences Or Impact To Patient 93 93
Obstruction/Occlusion 58 58
Transient Ischemic Attack 44 44
Stenosis 42 42
Myocardial Infarction 41 41
Restenosis 38 38
Vascular Dissection 32 32
Insufficient Information 30 30
Muscle Weakness 30 30
Low Blood Pressure/ Hypotension 27 27
Hematoma 18 18
Dysphasia 17 17
Intracranial Hemorrhage 17 17
Embolism/Embolus 15 15
Bradycardia 14 14
Hemorrhage/Bleeding 14 14
Brain Injury 14 14
Foreign Body In Patient 12 12
High Blood Pressure/ Hypertension 12 12
Unspecified Tissue Injury 11 11
Hemorrhagic Stroke 11 11
Paresis 8 8
Perforation of Vessels 8 8
No Known Impact Or Consequence To Patient 8 8
No Patient Involvement 7 7
Convulsion/Seizure 7 7
Pain 6 6
Thrombosis 6 6
Patient Problem/Medical Problem 6 6
Paralysis 6 6
Speech Disorder 6 6
Headache 6 6
Vasoconstriction 6 6
Dizziness 6 6
Ischemia 5 5
Nervous System Injury 4 4
Confusion/ Disorientation 4 4
Arrhythmia 4 4
Swelling/ Edema 4 4
Occlusion 4 4
Extravasation 4 4
Pseudoaneurysm 3 3
Cardiac Arrest 3 3
Death 3 3
Cerebral Hyperperfusion Syndrome 3 3
Unspecified Nervous System Problem 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Aug-08-2025
2 Contego Medical LLC II Oct-10-2025
3 Cordis Corporation I Mar-15-2021
4 Silk Road Medical Inc II Feb-23-2021
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