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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)
2021 2022 2023 2024 2025 2026
6 1 3 3 0 0

MDR Year MDR Reports MDR Events
2021 59 59
2022 62 65
2023 119 119
2024 262 262
2025 225 225
2026 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Separation Failure 230 230
Difficult or Delayed Separation 216 216
Adverse Event Without Identified Device or Use Problem 160 160
Device Dislodged or Dislocated 84 84
Migration 27 27
Premature Separation 21 21
Separation Problem 17 17
Unintended Movement 17 17
Detachment of Device or Device Component 12 12
Activation Failure 11 11
Retraction Problem 9 9
Material Deformation 9 9
Difficult or Delayed Positioning 9 9
Inadequacy of Device Shape and/or Size 8 8
Malposition of Device 6 6
Physical Resistance/Sticking 4 4
Device Markings/Labelling Problem 3 3
Difficult to Remove 3 3
Material Twisted/Bent 3 3
Deformation Due to Compressive Stress 2 2
Material Protrusion/Extrusion 2 2
Material Separation 2 2
Difficult or Delayed Activation 2 5
Dent in Material 2 2
Difficult to Advance 2 2
Material Invagination 2 2
Activation Problem 2 2
Off-Label Use 2 2
Break 2 2
Positioning Failure 1 1
Patient Device Interaction Problem 1 1
Contamination /Decontamination Problem 1 1
Failure to Fold 1 1
Positioning Problem 1 1
Packaging Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Filling Problem 1 1
Collapse 1 1
Migration or Expulsion of Device 1 1
Entrapment of Device 1 4
Fracture 1 1
Appropriate Term/Code Not Available 1 1
Device-Device Incompatibility 1 1
Failure to Disconnect 1 4
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 500 500
Aneurysm 54 54
Thrombosis/Thrombus 54 57
Ruptured Aneurysm 43 43
Obstruction/Occlusion 26 29
Ischemia Stroke 19 19
Stroke/CVA 17 17
Intracranial Hemorrhage 17 17
Hemorrhage/Bleeding 14 14
Speech Disorder 11 11
Paresis 11 11
Extravasation 9 9
Ischemia 8 8
Thromboembolism 7 7
Insufficient Information 6 6
Paralysis 6 6
Muscle Weakness 6 6
Rupture 5 5
Hematoma 5 5
Embolism/Embolus 4 4
Transient Ischemic Attack 4 4
Perforation 4 4
Brain Injury 4 7
Headache 4 4
Cerebral Edema 4 4
Numbness 3 3
Visual Impairment 3 3
Perforation of Vessels 3 3
Vasoconstriction 2 2
Hemorrhagic Stroke 2 2
Confusion/ Disorientation 2 2
Visual Disturbances 2 2
Memory Loss/Impairment 2 2
Blurred Vision 2 2
Convulsion/Seizure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cognitive Changes 1 1
Cardiac Arrest 1 1
Paresthesia 1 1
Unspecified Nervous System Problem 1 1
Vomiting 1 1
Vascular Dissection 1 1
Dizziness 1 1
Stenosis 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Myocardial Infarction 1 1
Failure of Implant 1 4
Fatigue 1 1
Eye Pain 1 1

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