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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intracranial coil-assist stent
Definition An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms.
Product CodeQCA
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 2 1 4 4 5 0 2

MDR Year MDR Reports MDR Events
2019 9 9
2020 16 16
2021 14 14
2022 23 23
2023 58 58
2024 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 72 72
Retraction Problem 34 34
Activation Failure 13 13
Break 12 12
Activation Problem 11 11
Detachment of Device or Device Component 8 8
Device Stenosis 4 4
Component Missing 4 4
Difficult to Open or Close 4 4
Device Dislodged or Dislocated 4 4
Difficult to Fold, Unfold or Collapse 3 3
Premature Separation 3 3
Material Separation 3 3
Difficult or Delayed Positioning 2 2
Migration 2 2
Difficult to Remove 2 2
Device-Device Incompatibility 2 2
No Apparent Adverse Event 1 1
Material Twisted/Bent 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Physical Resistance/Sticking 1 1
Difficult or Delayed Separation 1 1
Fracture 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75 75
Thrombosis/Thrombus 43 43
No Consequences Or Impact To Patient 12 12
Ischemia Stroke 11 11
Stenosis 9 9
Obstruction/Occlusion 8 8
Aneurysm 8 8
Speech Disorder 7 7
Muscle Weakness 5 5
Stroke/CVA 5 5
Paralysis 4 4
Transient Ischemic Attack 4 4
Thrombus 4 4
Death 3 3
Ruptured Aneurysm 3 3
Foreign Body In Patient 3 3
Confusion/ Disorientation 3 3
Perforation of Vessels 2 2
Paresis 2 2
Headache 2 2
Visual Impairment 2 2
Hemorrhage, Cerebral 2 2
Vertigo 2 2
Intracranial Hemorrhage 2 2
Numbness 1 1
Gastrointestinal Hemorrhage 1 1
Granuloma 1 1
Cyst(s) 1 1
Hyperplasia 1 1
Hemorrhage/Bleeding 1 1
Pneumonia 1 1
Thrombocytopenia 1 1
Memory Loss/Impairment 1 1
Vascular System (Circulation), Impaired 1 1
Ischemia 1 1
Foreign Body Reaction 1 1
Rupture 1 1
Intimal Dissection 1 1
Visual Disturbances 1 1
Meningitis 1 1
Insufficient Information 1 1
Hydrocephalus 1 1
Movement Disorder 1 1

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