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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 0

MDR Year MDR Reports MDR Events
2020 163 163
2021 201 201
2022 172 172
2023 172 172
2024 265 265
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 299 299
Activation, Positioning or Separation Problem 124 124
Difficult or Delayed Positioning 95 95
Material Deformation 82 82
Break 58 58
Difficult to Advance 56 56
Premature Activation 56 56
Difficult to Remove 55 55
Positioning Failure 49 49
Activation Failure 48 48
Material Separation 37 37
Detachment of Device or Device Component 36 36
Fracture 25 25
Mechanical Problem 25 25
Entrapment of Device 23 23
Failure to Advance 20 20
Malposition of Device 18 18
Mechanical Jam 17 17
Device Markings/Labelling Problem 16 16
Positioning Problem 16 16
Physical Resistance/Sticking 12 12
Defective Device 12 12
Material Integrity Problem 11 11
Difficult to Insert 9 9
Patient-Device Incompatibility 9 9
Device Dislodged or Dislocated 9 9
Migration 9 9
Difficult or Delayed Activation 7 7
Peeled/Delaminated 7 7
Deformation Due to Compressive Stress 7 7
Migration or Expulsion of Device 6 6
Use of Device Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Material Split, Cut or Torn 6 6
Device-Device Incompatibility 6 6
Device Contamination with Chemical or Other Material 6 6
Crack 5 5
Unsealed Device Packaging 4 4
Material Frayed 4 4
Loss of or Failure to Bond 4 4
Off-Label Use 3 3
Difficult to Open or Remove Packaging Material 3 3
Obstruction of Flow 3 3
Component Missing 3 3
Appropriate Term/Code Not Available 3 3
Defective Component 2 2
Loose or Intermittent Connection 2 2
Unclear Information 2 2
Device Difficult to Setup or Prepare 2 2
Contamination 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 535 535
Thrombosis/Thrombus 131 131
No Consequences Or Impact To Patient 93 93
Stroke/CVA 93 93
Ischemia Stroke 84 84
Obstruction/Occlusion 37 37
Stenosis 35 35
Transient Ischemic Attack 34 34
Myocardial Infarction 26 26
Vascular Dissection 24 24
Restenosis 24 24
Insufficient Information 19 19
Low Blood Pressure/ Hypotension 19 19
Muscle Weakness 19 19
Brain Injury 14 14
Bradycardia 14 14
Dysphasia 12 12
Foreign Body In Patient 12 12
Intracranial Hemorrhage 11 11
Unspecified Tissue Injury 11 11
Hematoma 11 11
Hemorrhage/Bleeding 9 9
Embolism/Embolus 9 9
No Known Impact Or Consequence To Patient 7 7
No Patient Involvement 7 7
Patient Problem/Medical Problem 6 6
Dizziness 6 6
Thrombosis 6 6
Pain 5 5
Convulsion/Seizure 5 5
Perforation of Vessels 4 4
Nervous System Injury 4 4
Extravasation 4 4
Speech Disorder 4 4
Vasoconstriction 4 4
Swelling/ Edema 4 4
High Blood Pressure/ Hypertension 4 4
Occlusion 4 4
Seizures 3 3
Confusion/ Disorientation 3 3
Aneurysm 3 3
Paresis 3 3
Hemorrhagic Stroke 3 3
Death 3 3
Ischemia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Infection 3 3
Unspecified Nervous System Problem 3 3
Thrombus 3 3
Loss of consciousness 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Cordis Corporation I Mar-15-2021
2 Silk Road Medical Inc II Feb-23-2021
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