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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
2014 282 282
2015 329 329
2016 310 310
2017 285 285
2018 422 422
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 1446 1446
Premature Activation 650 650
Failure to Advance 447 447
Activation Failure 196 196
Fracture 163 163
Break 124 124
Activation, Positioning or Separation Problem 87 87
Premature Separation 83 83
Physical Resistance 72 72
Migration or Expulsion of Device 63 63
Difficult or Delayed Activation 56 56
Migration 56 56
Difficult to Advance 51 51
Retraction Problem 50 50
No Apparent Adverse Event 44 44
Material Twisted/Bent 43 43
Activation Problem 38 38
Difficult to Remove 37 37
Physical Resistance/Sticking 36 36
Difficult or Delayed Positioning 35 35
Material Separation 30 30
Malposition of Device 30 30
Positioning Failure 22 22
Separation Failure 20 20
Device Operates Differently Than Expected 19 19
Occlusion Within Device 19 19
Entrapment of Device 17 17
Patient-Device Incompatibility 15 15
Device Dislodged or Dislocated 14 14
Delivery System Failure 13 13
Device Markings/Labelling Problem 12 12
Device Issue 10 10
Insufficient Information 10 10
Material Deformation 9 9
Detachment Of Device Component 9 9
Off-Label Use 9 9
Peeled/Delaminated 8 8
Impedance Problem 8 8
Component Missing 8 8
Detachment of Device or Device Component 8 8
Product Quality Problem 7 7
Unintended Movement 7 7
Appropriate Term/Code Not Available 6 6
Stretched 6 6
Unstable 6 6
Device-Device Incompatibility 6 6
Defective Device 5 5
Bent 5 5
Partial Blockage 5 5
Kinked 5 5
Positioning Problem 5 5
Radiation Underexposure 4 4
No Visual Prompts/Feedback 4 4
Misassembled 4 4
Sticking 3 3
Leak/Splash 3 3
Difficult to Insert 3 3
Material Too Soft/Flexible 3 3
Missing Value Reason 3 3
Difficult or Delayed Separation 2 2
Unclear Information 2 2
Flushing Problem 2 2
Difficult to Fold, Unfold or Collapse 2 2
Failure to Capture 2 2
Deformation Due to Compressive Stress 2 2
Failure to Deliver 2 2
Inaccurate Delivery 2 2
Structural Problem 2 2
Defective Component 2 2
Difficult to Open or Close 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Damaged by Another Device 2 2
Material Protrusion/Extrusion 2 2
Mechanical Jam 1 1
Device Contaminated During Manufacture or Shipping 1 1
Failure To Unwrap 1 1
Expiration Date Error 1 1
Split 1 1
Incomplete Coaptation 1 1
Biocompatibility 1 1
Coagulation in Device or Device Ingredient 1 1
Air Leak 1 1
Material Discolored 1 1
Device Expiration Issue 1 1
Flaked 1 1
Mechanical Problem 1 1
Shipping Damage or Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Damaged Prior to Use 1 1
Aborted Charge 1 1
Delivered as Unsterile Product 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Lack of Effect 1 1
Inaccurate Information 1 1
Premature Indicator Activation 1 1
Packaging Problem 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 743 743
Stroke/CVA 267 267
Thrombosis 222 222
Infarction, Cerebral 154 154
Death 124 124
Intracranial Hemorrhage 122 122
Aneurysm 118 118
Stenosis 116 116
Thromboembolism 114 114
Neurological Deficit/Dysfunction 105 105
Hemorrhage, Cerebral 93 93
Ischemia Stroke 88 88
Transient Ischemic Attack 80 80
No Known Impact Or Consequence To Patient 74 74
Hemorrhage, Subarachnoid 64 64
No Code Available 63 63
Vasoconstriction 59 59
Thrombosis/Thrombus 52 52
Restenosis 44 44
Thrombus 42 42
Ischemia 41 41
Hemorrhage/Bleeding 40 41
Vascular Dissection 34 34
Obstruction/Occlusion 33 33
Perforation of Vessels 33 33
Paralysis 32 32
Rupture 28 28
Occlusion 23 23
Headache 22 22
Hematoma 22 22
Embolism 19 19
No Patient Involvement 18 18
Embolism/Embolus 17 17
Ruptured Aneurysm 16 16
Coma 14 14
Visual Disturbances 13 13
Paresis 12 12
Device Embedded In Tissue or Plaque 12 12
Foreign Body In Patient 12 12
Patient Problem/Medical Problem 12 12
Insufficient Information 12 12
Unspecified Nervous System Problem 9 9
Pseudoaneurysm 9 9
Dysphasia 9 9
Hypersensitivity/Allergic reaction 9 9
High Blood Pressure/ Hypertension 8 8
Weakness 8 8
Hydrocephalus 8 8
No Information 7 7
Cognitive Changes 7 7
Muscle Weakness 7 7
Edema 7 7
Perforation 6 6
Visual Impairment 6 6
Loss of Vision 5 5
Hemorrhage, Intraventricular 5 5
Confusion/ Disorientation 5 5
Vascular System (Circulation), Impaired 5 5
Numbness 5 5
Paresthesia 5 5
Swelling/ Edema 4 4
Loss of consciousness 4 4
Embolus 4 4
Fatigue 4 4
Encephalopathy 3 3
Extravasation 3 3
Urinary Tract Infection 3 3
Vomiting 3 3
Septic Shock 3 3
Nausea 3 3
Ventilator Dependent 3 3
Injury 3 3
Lethargy 3 3
Not Applicable 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
Cerebral Edema 2 2
Multiple Organ Failure 2 2
Decreased Sensitivity 2 2
Spinal Cord Injury 2 2
Paraplegia 2 2
Quadriplegia 2 2
Hypoesthesia, Arm/Hand 2 2
Pain 2 2
Respiratory Distress 2 2
Pneumonia 2 2
Myocardial Infarction 2 2
Brain Injury 2 2
Neurogenic Shock 2 2
Vertigo 2 2
Fistula 2 2
Foreign Body Reaction 2 2
Bradycardia 2 2
Intimal Dissection 2 2
Diarrhea 2 2
Dysphagia/ Odynophagia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Dec-16-2010
2 Boston Scientific Corporation II Nov-26-2010
3 Boston Scientific Corporation II Sep-09-2009
4 Codman & Shurtleff, Inc. II Jun-29-2011
5 Stryker Neurovascular II Sep-07-2018
6 Stryker Neurovascular II Dec-16-2014
7 Stryker Neurovascular II Jul-25-2013
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