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TPLC
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show TPLC since
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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 Code
NIM
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
7
13
17
14
21
9
MDR Year
MDR Reports
MDR Events
2020
163
163
2021
201
201
2022
172
172
2023
172
172
2024
265
265
2025
186
186
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
352
352
Activation, Positioning or Separation Problem
149
149
Difficult or Delayed Positioning
109
109
Material Deformation
97
97
Difficult to Remove
70
70
Break
69
69
Activation Failure
62
62
Difficult to Advance
61
61
Premature Activation
59
59
Positioning Failure
52
52
Detachment of Device or Device Component
41
41
Entrapment of Device
40
40
Material Separation
38
38
Mechanical Problem
30
30
Fracture
28
28
Failure to Advance
22
22
Positioning Problem
22
22
Defective Device
20
20
Malposition of Device
18
18
Mechanical Jam
18
18
Device Markings/Labelling Problem
16
16
Migration
12
12
Physical Resistance/Sticking
12
12
Material Integrity Problem
12
12
Peeled/Delaminated
10
10
Device Dislodged or Dislocated
10
10
Patient-Device Incompatibility
10
10
Device-Device Incompatibility
9
9
Deformation Due to Compressive Stress
9
9
Difficult to Insert
9
9
Material Split, Cut or Torn
7
7
Difficult or Delayed Activation
7
7
Migration or Expulsion of Device
6
6
Device Contamination with Chemical or Other Material
6
6
Use of Device Problem
6
6
Improper or Incorrect Procedure or Method
6
6
Loss of or Failure to Bond
5
5
Crack
5
5
Unsealed Device Packaging
4
4
Appropriate Term/Code Not Available
4
4
Material Frayed
4
4
Component Missing
3
3
Obstruction of Flow
3
3
Difficult to Open or Remove Packaging Material
3
3
Off-Label Use
3
3
Device Difficult to Setup or Prepare
2
2
Contamination
2
2
Therapeutic or Diagnostic Output Failure
2
2
Loose or Intermittent Connection
2
2
Defective Component
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
642
642
Thrombosis/Thrombus
152
152
Stroke/CVA
103
103
Ischemia Stroke
94
94
No Consequences Or Impact To Patient
93
93
Obstruction/Occlusion
52
52
Stenosis
40
40
Transient Ischemic Attack
35
35
Restenosis
30
30
Myocardial Infarction
29
29
Vascular Dissection
27
27
Muscle Weakness
24
24
Low Blood Pressure/ Hypotension
22
22
Insufficient Information
19
19
Dysphasia
15
15
Bradycardia
14
14
Brain Injury
14
14
Intracranial Hemorrhage
13
13
Hematoma
13
13
Foreign Body In Patient
12
12
Embolism/Embolus
11
11
Unspecified Tissue Injury
11
11
Hemorrhage/Bleeding
11
11
Perforation of Vessels
7
7
No Patient Involvement
7
7
No Known Impact Or Consequence To Patient
7
7
Dizziness
6
6
Thrombosis
6
6
Patient Problem/Medical Problem
6
6
High Blood Pressure/ Hypertension
6
6
Convulsion/Seizure
5
5
Speech Disorder
5
5
Paresis
5
5
Pain
5
5
Occlusion
4
4
Vasoconstriction
4
4
Swelling/ Edema
4
4
Extravasation
4
4
Nervous System Injury
4
4
Aneurysm
3
3
Headache
3
3
Visual Impairment
3
3
Loss of consciousness
3
3
Thrombus
3
3
Unspecified Nervous System Problem
3
3
Confusion/ Disorientation
3
3
Unspecified Infection
3
3
Cardiac Arrest
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Hemorrhagic Stroke
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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