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TPLC
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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
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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