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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeNJE
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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