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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 88 88

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 559 559
Premature Activation 498 498
Failure to Advance 358 358
Fracture 150 150
Activation Failure 138 138
Break 55 55
Migration 53 53
Difficult or Delayed Activation 47 47
Premature Separation 45 45
Difficult to Advance 41 41
Material Twisted/Bent 37 37
Activation Problem 35 35
Retraction Problem 35 35
Physical Resistance/Sticking 27 27
Material Separation 24 24
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
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
Product Quality Problem 5 5
Misassembled 4 4
Difficult or Delayed Positioning 4 4
Activation, Positioning or Separation Problem 4 4
Defective Device 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
Deformation Due to Compressive Stress 2 2
Structural Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Difficult to Insert 2 2
Defective Component 2 2
Stretched 2 2
Delivered as Unsterile Product 1 1
Flaked 1 1
Difficult to Fold, Unfold or Collapse 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Expiration Date Error 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 1080 1080
No Consequences Or Impact To Patient 205 205
Stroke/CVA 97 97
Ischemia Stroke 84 84
Intracranial Hemorrhage 76 76
Thromboembolism 62 62
Thrombosis/Thrombus 51 51
Aneurysm 50 50
Restenosis 43 43
No Code Available 35 35
Obstruction/Occlusion 28 28
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
Vascular Dissection 12 12
Foreign Body In Patient 12 12
Insufficient Information 12 12
Headache 10 10
Neurological Deficit/Dysfunction 10 10
Thrombosis 10 10
No Known Impact Or Consequence To Patient 10 10
Unspecified Nervous System Problem 9 9
Hemorrhage/Bleeding 9 9
Thrombus 9 9
Ischemia 8 8
Paresis 7 7
Cognitive Changes 7 7
High Blood Pressure/ Hypertension 6 6
Hypersensitivity/Allergic reaction 6 6
Hemorrhage, Subarachnoid 5 5
Paresthesia 5 5
No Patient Involvement 5 5
Dysphasia 5 5
Coma 4 4
Muscle Weakness 4 4
Fatigue 4 4
Device Embedded In Tissue or Plaque 4 4
Perforation 4 4
Hematoma 4 4
Swelling/ Edema 4 4
Loss of Vision 4 4
Urinary Tract Infection 3 3
Speech Disorder 3 3
Visual Disturbances 3 3
Rupture 3 3
Vomiting 3 3
Hemorrhagic Stroke 3 3
Convulsion/Seizure 3 3
Cerebral Hyperperfusion Syndrome 3 3
Hydrocephalus 3 3
Nausea 3 3
Visual Impairment 3 3
Confusion/ Disorientation 2 2
Vertigo 2 2
Cerebral Edema 2 2
Injury 2 2
Pain 2 2
Diarrhea 2 2
Encephalopathy 2 2
Decreased Sensitivity 2 2
Numbness 2 2
Occlusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Loss of consciousness 2 2
Pseudoaneurysm 2 2
Myocardial Infarction 2 2
Edema 1 1
Blurred Vision 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoesthesia 1 1
Renal Failure 1 1
Air Embolism 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Dysphagia/ Odynophagia 1 1
Unspecified Infection 1 1
Decreased Appetite 1 1
Fistula 1 1
Hemostasis 1 1
Angina 1 1
Reaction 1 1
Urticaria 1 1
Failure of Implant 1 1
Extravasation 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Inflammation 1 1
Septic Shock 1 1
Bradycardia 1 1
Movement Disorder 1 1

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