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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 0

MDR Year MDR Reports MDR Events
2017 448 448
2018 425 425
2019 527 527
2020 809 809
2021 848 848

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 1582 1582
Adverse Event Without Identified Device or Use Problem 872 872
Physical Resistance/Sticking 349 349
Break 242 242
Material Deformation 161 161
Migration 85 85
Activation, Positioning or SeparationProblem 85 85
Unintended Movement 75 75
Positioning Failure 53 53
Retraction Problem 46 46
Migration or Expulsion of Device 43 43
Detachment of Device or Device Component 38 38
Physical Resistance 38 38
Unintended Ejection 37 37
No Apparent Adverse Event 33 33
Difficult to Open or Close 26 26
Premature Activation 23 23
Positioning Problem 23 23
Difficult or Delayed Activation 20 20
Difficult to Remove 14 14
Fracture 13 13
Appropriate Term/Code Not Available 13 13
Activation Problem 10 10
Premature Separation 8 8
Material Twisted/Bent 8 8
Difficult To Position 7 7
Device Dislodged or Dislocated 6 6
Malposition of Device 6 6
Deformation Due to Compressive Stress 5 5
Component or Accessory Incompatibility 4 4
Component Missing 4 4
Insufficient Information 4 4
Mechanical Jam 3 3
Obstruction of Flow 3 3
Patient-Device Incompatibility 3 3
Material Separation 3 3
Mechanical Problem 2 2
Difficult to Fold, Unfold or Collapse 2 2
Device Operates Differently Than Expected 2 2
Separation Failure 2 2
Difficult or Delayed Separation 2 2
High Readings 1 1
Structural Problem 1 1
Solder Joint Fracture 1 1
Collapse 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Incorrect Measurement 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Stretched 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1192 1192
No Clinical Signs, Symptoms or Conditions 761 761
Intracranial Hemorrhage 172 172
Thrombosis/Thrombus 141 141
Therapeutic Response, Decreased 131 131
Thrombosis 129 129
Death 127 127
Neurological Deficit/Dysfunction 111 111
Infarction, Cerebral 87 87
Stroke/CVA 85 85
Occlusion 82 82
Stenosis 78 78
No Consequences Or Impact To Patient 59 59
Obstruction/Occlusion 53 53
Thromboembolism 53 53
Ischemia 49 49
Paresis 48 48
Headache 45 45
Hemorrhage, Subarachnoid 44 44
Hemorrhage/Bleeding 39 39
Fistula 39 39
Muscle Weakness 37 37
Transient Ischemic Attack 34 34
Vasoconstriction 33 33
Paralysis 32 32
Hemorrhage, Cerebral 32 32
Ischemia Stroke 30 30
Visual Impairment 29 29
Thrombus 29 29
Foreign Body In Patient 28 28
Visual Disturbances 27 27
Dysphasia 27 27
Hematoma 25 25
Aneurysm 24 24
Device Embedded In Tissue or Plaque 22 22
Vascular Dissection 21 21
Rupture 20 20
Unspecified Nervous System Problem 18 18
Hydrocephalus 17 17
Loss of Vision 17 17
Speech Disorder 15 15
Edema 15 15
Insufficient Information 15 15
Perforation of Vessels 14 14
Embolus 12 12
Perforation 12 12
Pain 10 10
Seizures 10 10
Therapeutic Effects, Unexpected 10 10
Ruptured Aneurysm 9 9
Nerve Damage 9 9
Intimal Dissection 7 7
Dizziness 7 7
Blurred Vision 7 7
Swelling/ Edema 7 7
Brain Injury 6 6
Convulsion/Seizure 6 6
No Information 6 6
Pseudoaneurysm 6 6
Nausea 6 6
Memory Loss/Impairment 5 5
Tachycardia 5 5
Foreign Body Reaction 5 5
Cognitive Changes 5 5
No Patient Involvement 5 5
No Code Available 4 4
Cerebral Edema 4 4
Embolism/Embolus 4 4
Dyskinesia 4 4
High Blood Pressure/ Hypertension 4 4
Low Blood Pressure/ Hypotension 4 4
Hemorrhage, Intraventricular 3 3
Hyperplasia 3 3
Renal Failure 3 3
Emotional Changes 3 3
Bradycardia 3 3
Loss of consciousness 3 3
Hemorrhagic Stroke 3 3
Syncope/Fainting 3 3
Paraplegia 3 3
Shaking/Tremors 3 3
Ambulation Difficulties 2 2
Quadriplegia 2 2
Confusion/ Disorientation 2 2
Lethargy 2 2
Movement Disorder 2 2
Numbness 2 2
Seizures, Focal 2 2
Discomfort 2 2
Weakness 2 2
Cardiac Arrest 2 2
Arrhythmia 2 2
Bacterial Infection 2 2
Embolism 2 2
Dysphagia/ Odynophagia 2 2
Fatigue 2 2
Neuropathy 2 2
Myocardial Infarction 2 2
Unspecified Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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