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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)
2019 2020 2021 2022 2023 2024
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 102 102

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Separation 119 119
Adverse Event Without Identified Device or Use Problem 117 117
Separation Failure 52 52
Device Dislodged or Dislocated 48 48
Migration 15 15
Premature Separation 14 14
Detachment of Device or Device Component 12 12
Difficult or Delayed Positioning 12 12
Separation Problem 9 9
Unintended Movement 7 7
Difficult to Remove 6 6
Inadequacy of Device Shape and/or Size 6 6
Retraction Problem 5 5
Malposition of Device 4 4
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
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
Appropriate Term/Code Not Available 1 1
Material Protrusion/Extrusion 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Failure to Disconnect 1 1
Use of Device Problem 1 1
Contamination /Decontamination Problem 1 1
Off-Label Use 1 1
Material Separation 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 188 188
Aneurysm 43 43
Thrombosis/Thrombus 37 37
Ruptured Aneurysm 31 31
Rupture 15 15
Ischemia Stroke 14 14
Obstruction/Occlusion 12 12
Intracranial Hemorrhage 12 12
Hemorrhage/Bleeding 8 8
Stroke/CVA 8 8
Vascular System (Circulation), Impaired 8 8
Thromboembolism 7 7
Hemorrhage, Subarachnoid 7 7
Paresis 7 7
Neurological Deficit/Dysfunction 6 6
Brain Injury 6 6
Ischemia 6 6
Death 6 6
Speech Disorder 5 5
No Consequences Or Impact To Patient 5 5
Extravasation 4 4
Hematoma 4 4
Visual Impairment 3 3
Paralysis 3 3
Thrombus 3 3
Transient Ischemic Attack 3 3
Cerebral Edema 3 3
Convulsion/Seizure 2 2
Embolism/Embolus 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Perforation of Vessels 2 2
Perforation 2 2
Hemorrhage, Cerebral 2 2
Muscle Weakness 2 2
Myocardial Infarction 1 1
Failure of Implant 1 1
Intimal Dissection 1 1
Fatigue 1 1
Headache 1 1
Infarction, Cerebral 1 1
Cardiac Arrest 1 1
Blurred Vision 1 1
Vasoconstriction 1 1
Visual Disturbances 1 1
Vomiting 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Stenosis 1 1
Numbness 1 1
Eye Pain 1 1
Unspecified Tissue Injury 1 1
Unspecified Nervous System Problem 1 1
Hemorrhagic Stroke 1 1
Vascular Dissection 1 1
Device Embedded In Tissue or Plaque 1 1

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