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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
167
167
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
567
567
Premature Activation
534
534
Failure to Advance
387
387
Fracture
156
156
Activation Failure
149
149
Break
55
55
Migration
53
53
Difficult or Delayed Activation
52
52
Premature Separation
45
45
Difficult to Advance
44
44
Material Twisted/Bent
40
40
Retraction Problem
36
36
Activation Problem
35
35
Physical Resistance/Sticking
27
27
Material Separation
25
25
Malposition of Device
20
20
Separation Failure
19
19
Patient-Device Incompatibility
14
14
Entrapment of Device
14
14
Positioning Failure
13
13
Difficult to Remove
11
11
Device Dislodged or Dislocated
9
9
Component Missing
8
8
Off-Label Use
7
7
Migration or Expulsion of Device
7
7
Product Quality Problem
6
6
Unstable
6
6
Material Deformation
6
6
Detachment of Device or Device Component
6
6
Device Markings/Labelling Problem
6
6
No Apparent Adverse Event
6
6
Defective Device
5
5
Activation, Positioning or Separation Problem
4
4
Misassembled
4
4
Difficult or Delayed Positioning
4
4
Unintended Movement
4
4
No Visual Prompts/Feedback
4
4
Material Too Soft/Flexible
2
2
Difficult or Delayed Separation
2
2
Unclear Information
2
2
Difficult to Insert
2
2
Defective Component
2
2
Stretched
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Deformation Due to Compressive Stress
2
2
Structural Problem
2
2
Expiration Date Error
1
1
Device Damaged by Another Device
1
1
Device-Device Incompatibility
1
1
Delivered as Unsterile Product
1
1
Flaked
1
1
Difficult to Fold, Unfold or Collapse
1
1
Lack of Effect
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1150
1150
No Consequences Or Impact To Patient
205
205
Stroke/CVA
97
97
Ischemia Stroke
88
88
Intracranial Hemorrhage
77
77
Thromboembolism
62
62
Thrombosis/Thrombus
52
52
Aneurysm
50
50
Restenosis
44
44
No Code Available
35
35
Obstruction/Occlusion
30
30
Vasoconstriction
27
27
Infarction, Cerebral
26
26
Transient Ischemic Attack
24
24
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
1
1
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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