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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 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 16 16
2021 14 14
2022 23 23
2023 58 58
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 63 63
Retraction Problem 26 26
Activation Failure 12 12
Detachment of Device or Device Component 8 8
Break 7 7
Activation Problem 6 6
Component Missing 3 3
Device Dislodged or Dislocated 3 3
Device-Device Incompatibility 2 2
Difficult to Open or Close 2 2
Difficult or Delayed Positioning 2 2
Difficult to Fold, Unfold or Collapse 2 2
Material Separation 2 2
Difficult to Remove 2 2
Premature Separation 2 2
Device Stenosis 2 2
Difficult or Delayed Separation 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fracture 1 1
Material Deformation 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 56 56
Thrombosis/Thrombus 32 32
No Consequences Or Impact To Patient 12 12
Ischemia Stroke 8 8
Aneurysm 8 8
Stenosis 7 7
Obstruction/Occlusion 7 7
Speech Disorder 6 6
Thrombus 4 4
Transient Ischemic Attack 3 3
Muscle Weakness 3 3
Paralysis 3 3
Death 3 3
Foreign Body In Patient 3 3
Confusion/ Disorientation 3 3
Ruptured Aneurysm 3 3
Headache 2 2
Stroke/CVA 2 2
Hemorrhage, Cerebral 2 2
Intracranial Hemorrhage 2 2
Paresis 2 2
Vertigo 2 2
Perforation of Vessels 2 2
Visual Impairment 2 2
Visual Disturbances 1 1
Pneumonia 1 1
Hyperplasia 1 1
Ischemia 1 1
Cyst(s) 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Hemorrhage/Bleeding 1 1
Rupture 1 1
Vascular System (Circulation), Impaired 1 1
Meningitis 1 1
Numbness 1 1
Hydrocephalus 1 1
Intimal Dissection 1 1
Thrombocytopenia 1 1
Insufficient Information 1 1

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