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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)
2016 2017 2018 2019 2020 2021
1 1 7 5 9 10

MDR Year MDR Reports MDR Events
2016 540 540
2017 448 448
2018 425 425
2019 527 527
2020 809 809
2021 514 514

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 1684 1684
Adverse Event Without Identified Device or Use Problem 937 937
Physical Resistance/Sticking 276 276
Break 262 262
Material Deformation 118 118
Positioning Failure 87 87
Migration 71 71
Migration or Expulsion of Device 69 69
Activation, Positioning or SeparationProblem 67 67
Unintended Movement 64 64
Detachment of Device or Device Component 54 54
Physical Resistance 48 48
Retraction Problem 41 41
Unintended Ejection 30 30
No Apparent Adverse Event 29 29
Difficult to Open or Close 27 27
Positioning Problem 23 23
Difficult or Delayed Activation 17 17
Appropriate Term/Code Not Available 14 14
Fracture 13 13
Premature Activation 13 13
Difficult to Remove 13 13
Difficult To Position 12 12
Activation Problem 9 9
Material Twisted/Bent 8 8
Premature Separation 8 8
Malposition of Device 6 6
Flaked 5 5
Deformation Due to Compressive Stress 5 5
Delamination 4 4
Component Missing 4 4
Insufficient Information 4 4
Obstruction of Flow 3 3
Patient-Device Incompatibility 3 3
Component or Accessory Incompatibility 3 3
Mechanical Jam 3 3
Material Separation 3 3
Collapse 3 3
Stretched 2 2
Mechanical Problem 2 2
Device Dislodged or Dislocated 2 2
Device Operates Differently Than Expected 2 2
Separation Failure 2 2
Difficult to Fold, Unfold or Collapse 2 2
Kinked 2 2
Improper or Incorrect Procedure or Method 1 1
Solder Joint Fracture 1 1
High Readings 1 1
Material Frayed 1 1
Difficult to Advance 1 1
Detachment Of Device Component 1 1
Structural Problem 1 1
Device Damaged by Another Device 1 1
Material Perforation 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
Incorrect Measurement 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1529 1529
No Clinical Signs, Symptoms or Conditions 548 548
Therapeutic Response, Decreased 193 193
Intracranial Hemorrhage 178 178
Thrombosis 149 149
Death 137 137
Neurological Deficit/Dysfunction 120 120
Infarction, Cerebral 106 106
Thrombosis/Thrombus 97 97
Occlusion 96 96
Stenosis 73 73
Stroke/CVA 69 69
No Consequences Or Impact To Patient 61 61
Thromboembolism 53 53
Paresis 51 51
Hemorrhage, Subarachnoid 48 48
Ischemia 47 47
Hemorrhage, Cerebral 44 44
Fistula 44 44
Foreign Body In Patient 38 38
Hemorrhage/Bleeding 37 37
Obstruction/Occlusion 36 36
Vasoconstriction 33 33
Headache 31 31
Paralysis 30 30
Thrombus 29 29
Visual Impairment 28 28
Transient Ischemic Attack 27 27
Muscle Weakness 27 27
Hematoma 27 27
Device Embedded In Tissue or Plaque 25 25
Vascular Dissection 23 23
Rupture 20 20
Visual Disturbances 20 20
Ischemia Stroke 20 20
Dysphasia 20 20
Aneurysm 19 19
Perforation 18 18
Edema 17 17
Loss of Vision 15 15
Hydrocephalus 14 14
Perforation of Vessels 14 14
Seizures 12 12
Embolus 12 12
Nerve Damage 11 11
Pain 10 10
Speech Disorder 10 10
Therapeutic Effects, Unexpected 10 10
Insufficient Information 9 9
Brain Injury 9 9
Unspecified Nervous System Problem 9 9
Foreign Body Reaction 8 8
Intimal Dissection 8 8
Blurred Vision 6 6
No Information 6 6
Pseudoaneurysm 5 5
No Patient Involvement 5 5
Memory Loss/Impairment 5 5
High Blood Pressure/ Hypertension 4 4
Convulsion/Seizure 4 4
Swelling/ Edema 4 4
Ruptured Aneurysm 4 4
Dyskinesia 4 4
No Code Available 4 4
Dizziness 4 4
Tachycardia 4 4
Nausea 3 3
Paraplegia 3 3
Shaking/Tremors 3 3
Cerebral Edema 3 3
Embolism/Embolus 3 3
Cognitive Changes 3 3
Low Blood Pressure/ Hypotension 3 3
Hemorrhage, Intraventricular 3 3
Neuropathy 3 3
Inflammation 2 2
Fatigue 2 2
Air Embolism 2 2
Emotional Changes 2 2
Quadriplegia 2 2
Ambulation Difficulties 2 2
Seizures, Focal 2 2
Numbness 2 2
Loss of consciousness 2 2
Unspecified Tissue Injury 2 2
Discomfort 2 2
Weakness 2 2
Arrhythmia 2 2
Embolism 2 2
Eye Injury 1 1
Facial Nerve Paralysis 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Angina 1 1
Apheresis 1 1
Deafness 1 1
Ecchymosis 1 1
Burning Sensation 1 1
Hemorrhage, Subdural 1 1
Optical Nerve Damage 1 1

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
3 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
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