Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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)
2021 2022 2023 2024 2025 2026
4 5 0 6 2 0

MDR Year MDR Reports MDR Events
2021 14 14
2022 23 23
2023 58 58
2024 153 153
2025 323 323
2026 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Premature Activation 224 224
Adverse Event Without Identified Device or Use Problem 140 140
Fracture 60 60
Retraction Problem 49 49
Activation Failure 38 38
Difficult or Delayed Activation 36 36
Activation Problem 22 22
Break 15 15
Migration 15 15
Difficult to Open or Close 7 7
Detachment of Device or Device Component 6 6
Material Separation 6 6
Device Stenosis 6 6
Structural Problem 6 6
Premature Separation 5 5
Difficult to Fold, Unfold or Collapse 5 5
Component Missing 5 5
Difficult to Insert 5 5
Difficult to Remove 5 5
Device Dislodged or Dislocated 4 4
Entrapment of Device 4 4
Patient Device Interaction Problem 2 2
Material Fragmentation 2 2
Difficult to Advance 2 2
Material Twisted/Bent 2 2
Difficult or Delayed Positioning 2 2
Material Deformation 2 2
Physical Resistance/Sticking 2 2
Migration or Expulsion of Device 2 2
Expulsion 2 2
Contamination 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Battery Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Unintended Movement 1 1
Obstruction of Flow 1 1
Patient-Device Incompatibility 1 1
Incomplete or Inadequate Connection 1 1
Misassembled 1 1
Difficult or Delayed Separation 1 1
Failure to Capture 1 1
No Visual Prompts/Feedback 1 1
Malposition of Device 1 1
No Apparent Adverse Event 1 1
Separation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device-Device Incompatibility 1 1
Display or Visual Feedback Problem 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 451 451
Thrombosis/Thrombus 66 66
Obstruction/Occlusion 24 24
Ischemia Stroke 23 23
Aneurysm 14 14
Stroke/CVA 13 13
Muscle Weakness 12 12
Stenosis 12 12
Speech Disorder 11 11
Foreign Body In Patient 10 10
Ruptured Aneurysm 7 7
Transient Ischemic Attack 7 7
Headache 7 7
Paralysis 6 6
Paresis 5 5
Confusion/ Disorientation 5 5
Intracranial Hemorrhage 5 5
Hemorrhage/Bleeding 4 4
Insufficient Information 4 4
Hydrocephalus 3 3
Numbness 3 3
Coma 2 2
Hemorrhagic Stroke 2 2
Embolism/Embolus 2 2
Nausea 2 2
Hyperplasia 2 2
High Blood Pressure/ Hypertension 2 2
Vertigo 2 2
Visual Impairment 2 2
Visual Disturbances 1 1
Dysphasia 1 1
Rupture 1 1
Pneumonia 1 1
Vasoconstriction 1 1
Perforation of Vessels 1 1
Meningitis 1 1
Lethargy 1 1
Thromboembolism 1 1
Inflammation 1 1
Ischemia 1 1
Memory Loss/Impairment 1 1
Neuropathy 1 1
Cyst(s) 1 1
Death 1 1
Dysphagia/ Odynophagia 1 1
Extravasation 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Paresthesia 1 1
Thrombocytopenia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MICROVENTION INC. II Feb-07-2025
-
-