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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)
2017 2018 2019 2020 2021 2022
0 2 1 4 4 4

MDR Year MDR Reports MDR Events
2019 9 9
2020 16 16
2021 14 14
2022 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18 18
Retraction Problem 14 14
Activation Failure 7 7
Detachment of Device or Device Component 4 4
Device Dislodged or Dislocated 3 3
Device-Device Incompatibility 2 2
Component Missing 2 2
Difficult to Remove 2 2
Difficult to Fold, Unfold or Collapse 2 2
Fracture 1 1
Break 1 1
Difficult or Delayed Positioning 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Difficult to Open or Close 1 1
Material Deformation 1 1
Migration 1 1
Activation Problem 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 25 25
No Consequences Or Impact To Patient 12 12
Thrombosis/Thrombus 8 8
Aneurysm 4 4
Obstruction/Occlusion 4 4
Thrombus 4 4
Death 3 3
Stenosis 2 2
Hemorrhage, Cerebral 2 2
Ruptured Aneurysm 2 2
Intracranial Hemorrhage 1 1
Ischemia 1 1
Muscle Weakness 1 1
Vertigo 1 1
Perforation of Vessels 1 1
Visual Impairment 1 1
Intimal Dissection 1 1
Vascular System (Circulation), Impaired 1 1
Hydrocephalus 1 1
Headache 1 1
Rupture 1 1

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