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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intrasaccular flow disruption device
Definition An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.
Product CodeOPR
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 1 1 3 6 1 3 1

MDR Year MDR Reports MDR Events
2019 21 21
2020 11 11
2021 59 59
2022 62 62
2023 119 119
2024 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 111 111
Difficult or Delayed Separation 109 109
Device Dislodged or Dislocated 48 48
Separation Failure 43 43
Premature Separation 13 13
Migration 13 13
Difficult or Delayed Positioning 12 12
Detachment of Device or Device Component 11 11
Separation Problem 8 8
Unintended Movement 6 6
Difficult to Remove 6 6
Inadequacy of Device Shape and/or Size 6 6
Retraction Problem 5 5
Activation Failure 4 4
Material Twisted/Bent 3 3
Device Markings/Labelling Problem 3 3
Material Deformation 3 3
Migration or Expulsion of Device 3 3
Malposition of Device 3 3
Deformation Due to Compressive Stress 2 2
Difficult or Delayed Activation 2 2
Dent in Material 2 2
Physical Resistance/Sticking 2 2
Activation Problem 2 2
Material Protrusion/Extrusion 1 1
Device-Device Incompatibility 1 1
Appropriate Term/Code Not Available 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Failure to Disconnect 1 1
Use of Device Problem 1 1
Contamination /Decontamination Problem 1 1
Off-Label Use 1 1
Entrapment of Device 1 1
Filling Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Invagination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 171 171
Aneurysm 43 43
Thrombosis/Thrombus 35 35
Ruptured Aneurysm 28 28
Rupture 15 15
Ischemia Stroke 14 14
Obstruction/Occlusion 12 12
Intracranial Hemorrhage 11 11
Stroke/CVA 8 8
Vascular System (Circulation), Impaired 8 8
Thromboembolism 7 7
Paresis 7 7
Hemorrhage, Subarachnoid 7 7
Hemorrhage/Bleeding 7 7
Ischemia 6 6
Neurological Deficit/Dysfunction 6 6
Death 6 6
Brain Injury 6 6
Speech Disorder 5 5
No Consequences Or Impact To Patient 5 5
Visual Impairment 3 3
Thrombus 3 3
Extravasation 3 3
Hematoma 3 3
Paralysis 3 3
Muscle Weakness 2 2
Hemorrhage, Cerebral 2 2
Transient Ischemic Attack 2 2
Perforation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Embolism/Embolus 2 2
Cerebral Edema 2 2
Convulsion/Seizure 2 2
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Hemorrhagic Stroke 1 1
Unspecified Nervous System Problem 1 1
Eye Pain 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
Visual Disturbances 1 1
Vomiting 1 1
Vasoconstriction 1 1
Perforation of Vessels 1 1
Blurred Vision 1 1
Stenosis 1 1
Numbness 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
Failure of Implant 1 1
Myocardial Infarction 1 1
Intimal Dissection 1 1
Infarction, Cerebral 1 1
Fatigue 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MICROVENTION INC. II Nov-02-2022
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