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TPLC
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Device
intracranial neurovascular stent
Definition
An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.
Product Code
NJE
Device Class
Humanitarian Device Exemption
MDR Year
MDR Reports
MDR Events
2019
272
272
2020
193
193
2021
382
382
2022
395
395
2023
580
580
2024
235
235
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
575
575
Premature Activation
561
561
Failure to Advance
412
412
Activation Failure
160
160
Fracture
157
157
Break
55
55
Difficult or Delayed Activation
54
54
Migration
53
53
Premature Separation
45
45
Difficult to Advance
44
44
Material Twisted/Bent
41
41
Activation Problem
36
36
Retraction Problem
36
36
Physical Resistance/Sticking
27
27
Material Separation
25
25
Malposition of Device
21
21
Separation Failure
19
19
Entrapment of Device
15
15
Patient-Device Incompatibility
14
14
Positioning Failure
13
13
Difficult to Remove
11
11
Device Dislodged or Dislocated
9
9
Component Missing
8
8
Product Quality Problem
8
8
Off-Label Use
7
7
Migration or Expulsion of Device
7
7
Material Deformation
7
7
Detachment of Device or Device Component
6
6
Device Markings/Labelling Problem
6
6
Unstable
6
6
No Apparent Adverse Event
6
6
Misassembled
5
5
Defective Device
5
5
Difficult or Delayed Positioning
4
4
Activation, Positioning or Separation Problem
4
4
No Visual Prompts/Feedback
4
4
Unintended Movement
4
4
Unclear Information
2
2
Material Too Soft/Flexible
2
2
Difficult or Delayed Separation
2
2
Difficult to Insert
2
2
Defective Component
2
2
Stretched
2
2
Structural Problem
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Deformation Due to Compressive Stress
2
2
Device Damaged by Another Device
1
1
Device-Device Incompatibility
1
1
Expiration Date Error
1
1
Delivered as Unsterile Product
1
1
Flaked
1
1
Difficult to Fold, Unfold or Collapse
1
1
Inaccurate Information
1
1
Appropriate Term/Code Not Available
1
1
Packaging Problem
1
1
Positioning Problem
1
1
Premature Indicator Activation
1
1
Lack of Effect
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1208
1208
No Consequences Or Impact To Patient
205
205
Stroke/CVA
97
97
Ischemia Stroke
88
88
Intracranial Hemorrhage
78
78
Thromboembolism
63
63
Thrombosis/Thrombus
55
55
Aneurysm
50
50
Restenosis
46
46
No Code Available
35
35
Obstruction/Occlusion
32
32
Transient Ischemic Attack
29
29
Vasoconstriction
27
27
Infarction, Cerebral
26
26
Hemorrhage, Cerebral
23
23
Stenosis
22
22
Perforation of Vessels
20
20
Paralysis
20
20
Death
19
19
Embolism/Embolus
17
17
Ruptured Aneurysm
16
16
Insufficient Information
12
12
Vascular Dissection
12
12
Foreign Body In Patient
12
12
No Known Impact Or Consequence To Patient
10
10
Headache
10
10
Neurological Deficit/Dysfunction
10
10
Thrombosis
10
10
Thrombus
9
9
Hemorrhage/Bleeding
9
9
Unspecified Nervous System Problem
9
9
Ischemia
8
8
Paresis
7
7
Cognitive Changes
7
7
Hypersensitivity/Allergic reaction
6
6
High Blood Pressure/ Hypertension
6
6
Hematoma
6
6
Hemorrhage, Subarachnoid
5
5
No Patient Involvement
5
5
Dysphasia
5
5
Paresthesia
5
5
Swelling/ Edema
4
4
Loss of Vision
4
4
Coma
4
4
Device Embedded In Tissue or Plaque
4
4
Fatigue
4
4
Muscle Weakness
4
4
Perforation
4
4
Nausea
3
3
Hydrocephalus
3
3
Visual Disturbances
3
3
Vomiting
3
3
Urinary Tract Infection
3
3
Visual Impairment
3
3
Rupture
3
3
Cerebral Hyperperfusion Syndrome
3
3
Convulsion/Seizure
3
3
Speech Disorder
3
3
Hemorrhagic Stroke
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Injury
2
2
Vertigo
2
2
Cerebral Edema
2
2
Decreased Sensitivity
2
2
Loss of consciousness
2
2
Numbness
2
2
Confusion/ Disorientation
2
2
Pseudoaneurysm
2
2
Myocardial Infarction
2
2
Occlusion
2
2
Pain
2
2
Diarrhea
2
2
Encephalopathy
2
2
Extravasation
2
2
Angina
1
1
Bradycardia
1
1
Dysphagia/ Odynophagia
1
1
Edema
1
1
Fistula
1
1
Hemostasis
1
1
Air Embolism
1
1
Renal Failure
1
1
Septic Shock
1
1
Low Blood Pressure/ Hypotension
1
1
Failure of Implant
1
1
Unspecified Infection
1
1
Inflammation
1
1
Blurred Vision
1
1
Hypoesthesia
1
1
Reaction
1
1
Urticaria
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Decreased Appetite
1
1
Movement Disorder
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
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