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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 2

MDR Year MDR Reports MDR Events
2019 21 21
2020 11 11
2021 59 59
2022 62 62
2023 119 119
2024 188 188

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult or Delayed Separation 148 148
Adverse Event Without Identified Device or Use Problem 130 130
Separation Failure 82 82
Device Dislodged or Dislocated 55 55
Migration 18 18
Premature Separation 17 17
Difficult or Delayed Positioning 14 14
Detachment of Device or Device Component 14 14
Separation Problem 13 13
Unintended Movement 9 9
Retraction Problem 8 8
Activation Failure 7 7
Difficult to Remove 6 6
Inadequacy of Device Shape and/or Size 6 6
Material Deformation 5 5
Malposition of Device 4 4
Migration or Expulsion of Device 4 4
Material Twisted/Bent 3 3
Device Markings/Labelling Problem 3 3
Activation Problem 2 2
Physical Resistance/Sticking 2 2
Difficult or Delayed Activation 2 2
Dent in Material 2 2
Difficult to Advance 2 2
Material Separation 2 2
Material Protrusion/Extrusion 2 2
Deformation Due to Compressive Stress 2 2
Entrapment of Device 1 1
Off-Label Use 1 1
Use of Device Problem 1 1
Appropriate Term/Code Not Available 1 1
Device-Device Incompatibility 1 1
Filling Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Invagination 1 1
Positioning Problem 1 1
Packaging Problem 1 1
Contamination /Decontamination Problem 1 1
Failure to Fold 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 248 248
Aneurysm 45 45
Thrombosis/Thrombus 43 43
Ruptured Aneurysm 33 33
Obstruction/Occlusion 19 19
Rupture 17 17
Ischemia Stroke 16 16
Intracranial Hemorrhage 12 12
Stroke/CVA 11 11
Hemorrhage/Bleeding 11 11
Paresis 10 10
Vascular System (Circulation), Impaired 8 8
Thromboembolism 7 7
Hemorrhage, Subarachnoid 7 7
Ischemia 7 7
Death 6 6
Speech Disorder 6 6
Brain Injury 6 6
Extravasation 6 6
Neurological Deficit/Dysfunction 6 6
No Consequences Or Impact To Patient 5 5
Hematoma 5 5
Cerebral Edema 4 4
Perforation 4 4
Thrombus 3 3
Visual Impairment 3 3
Insufficient Information 3 3
Paralysis 3 3
Transient Ischemic Attack 3 3
Visual Disturbances 2 2
Confusion/ Disorientation 2 2
Hemorrhage, Cerebral 2 2
Muscle Weakness 2 2
Perforation of Vessels 2 2
Embolism/Embolus 2 2
Convulsion/Seizure 2 2
Headache 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Cardiac Arrest 1 1
Vomiting 1 1
Numbness 1 1
Unspecified Nervous System Problem 1 1
Cognitive Changes 1 1
Hemorrhagic Stroke 1 1
Unspecified Tissue Injury 1 1
Stenosis 1 1
Vasoconstriction 1 1
Myocardial Infarction 1 1
Blurred Vision 1 1
Memory Loss/Impairment 1 1

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