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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intracranial aneurysm flow diverter
Definition Treatment of wide-necked and larger or giant intracranial aneurysms.
Product CodeOUT
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
1 7 5 9 13 6

MDR Year MDR Reports MDR Events
2017 448 448
2018 425 425
2019 527 527
2020 809 809
2021 849 849
2022 742 742

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 1939 1939
Adverse Event Without Identified Device or Use Problem 1121 1121
Physical Resistance/Sticking 453 453
Break 254 254
Material Deformation 234 234
Activation, Positioning or SeparationProblem 123 123
Unintended Movement 108 108
Migration 104 104
Positioning Failure 63 63
Retraction Problem 56 56
Unintended Ejection 43 43
Migration or Expulsion of Device 43 43
Premature Activation 43 43
Detachment of Device or Device Component 40 40
No Apparent Adverse Event 39 39
Physical Resistance 38 38
Difficult to Open or Close 28 28
Difficult or Delayed Activation 24 24
Positioning Problem 23 23
Difficult to Remove 23 23
Activation Problem 19 19
Appropriate Term/Code Not Available 17 17
Material Twisted/Bent 17 17
Fracture 16 16
Device Dislodged or Dislocated 10 10
Premature Separation 9 9
Malposition of Device 8 8
Difficult To Position 7 7
Deformation Due to Compressive Stress 5 5
Component or Accessory Incompatibility 4 4
Patient-Device Incompatibility 4 4
Component Missing 4 4
Insufficient Information 4 4
Mechanical Jam 3 3
Difficult or Delayed Separation 3 3
Obstruction of Flow 3 3
Material Separation 3 3
Separation Failure 2 2
Difficult to Fold, Unfold or Collapse 2 2
Mechanical Problem 2 2
Device Operates Differently Than Expected 2 2
No Flow 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Fluid Leak 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Incorrect Measurement 1 1
Entrapment of Device 1 1
Collapse 1 1
Defective Device 1 1
Stretched 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
High Readings 1 1
Structural Problem 1 1
Solder Joint Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1206 1206
No Known Impact Or Consequence To Patient 1192 1192
Intracranial Hemorrhage 200 200
Thrombosis/Thrombus 200 200
Stenosis 162 162
Stroke/CVA 134 134
Therapeutic Response, Decreased 131 131
Thrombosis 129 129
Death 127 127
Neurological Deficit/Dysfunction 111 111
Infarction, Cerebral 87 87
Occlusion 82 82
Obstruction/Occlusion 76 76
Headache 69 69
Thromboembolism 68 68
Hemorrhage/Bleeding 62 62
Ischemia 60 60
Paresis 60 60
No Consequences Or Impact To Patient 59 59
Muscle Weakness 52 52
Paralysis 44 44
Hemorrhage, Subarachnoid 44 44
Fistula 44 44
Visual Disturbances 42 42
Transient Ischemic Attack 41 41
Unspecified Nervous System Problem 40 40
Vasoconstriction 38 38
Ischemia Stroke 38 38
Visual Impairment 35 35
Dysphasia 35 35
Rupture 34 34
Hematoma 34 34
Hemorrhage, Cerebral 32 32
Insufficient Information 32 32
Foreign Body In Patient 31 31
Vascular Dissection 30 30
Aneurysm 30 30
Thrombus 29 29
Loss of Vision 28 28
Device Embedded In Tissue or Plaque 25 25
Swelling/ Edema 22 22
Hydrocephalus 21 21
Speech Disorder 21 21
Perforation of Vessels 17 17
Perforation 16 16
Pain 15 15
Edema 15 15
Blurred Vision 15 15
Pseudoaneurysm 14 14
Nausea 13 13
Embolus 12 12
Nerve Damage 11 11
Ruptured Aneurysm 11 11
Seizures 10 10
Therapeutic Effects, Unexpected 10 10
Convulsion/Seizure 9 9
Low Blood Pressure/ Hypotension 9 9
Cognitive Changes 8 8
Dizziness 8 8
Embolism/Embolus 8 8
Brain Injury 7 7
Loss of consciousness 7 7
Confusion/ Disorientation 7 7
High Blood Pressure/ Hypertension 7 7
Memory Loss/Impairment 7 7
Intimal Dissection 7 7
Foreign Body Reaction 6 6
Neuropathy 6 6
Syncope/Fainting 6 6
No Information 6 6
Cerebral Edema 5 5
No Patient Involvement 5 5
Shaking/Tremors 5 5
Numbness 5 5
Tachycardia 5 5
Hyperplasia 5 5
Hypersensitivity/Allergic reaction 5 5
Unspecified Infection 4 4
Arrhythmia 4 4
Bradycardia 4 4
Cardiac Arrest 4 4
Discomfort 4 4
Dyskinesia 4 4
No Code Available 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Partial Hearing Loss 3 3
Movement Disorder 3 3
Hemorrhagic Stroke 3 3
Paraplegia 3 3
Renal Failure 3 3
Coagulation Disorder 3 3
Pulmonary Embolism 3 3
Granuloma 3 3
Feeding Problem 3 3
Emotional Changes 3 3
Dysphagia/ Odynophagia 3 3
Hemorrhage, Intraventricular 3 3
Inflammation 2 2
Fatigue 2 2
Optical Nerve Damage 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics Inc, I Sep-03-2021
2 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Mar-09-2020
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