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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)
2018 2019 2020 2021 2022 2023
7 5 9 13 7 0

MDR Year MDR Reports MDR Events
2018 425 425
2019 527 527
2020 809 809
2021 850 850
2022 1118 1118

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 1957 1957
Adverse Event Without Identified Device or Use Problem 1026 1026
Physical Resistance/Sticking 519 519
Material Deformation 289 289
Break 230 230
Activation, Positioning or Separation Problem 140 140
Unintended Movement 121 121
Migration 112 112
Positioning Failure 72 72
Retraction Problem 60 60
Unintended Ejection 54 54
Premature Activation 52 52
No Apparent Adverse Event 43 43
Detachment of Device or Device Component 36 36
Difficult to Open or Close 31 31
Activation Problem 26 26
Difficult or Delayed Activation 26 26
Difficult to Remove 24 24
Material Twisted/Bent 20 20
Positioning Problem 20 20
Migration or Expulsion of Device 19 19
Fracture 18 18
Physical Resistance 12 12
Device Dislodged or Dislocated 12 12
Appropriate Term/Code Not Available 9 9
Premature Separation 9 9
Malposition of Device 8 8
Deformation Due to Compressive Stress 7 7
Component or Accessory Incompatibility 5 5
Insufficient Information 4 4
Patient-Device Incompatibility 4 4
Component Missing 4 4
Difficult To Position 4 4
Material Separation 3 3
Obstruction of Flow 3 3
Mechanical Jam 3 3
Difficult or Delayed Separation 3 3
Packaging Problem 2 2
Stretched 2 2
Separation Failure 2 2
Material Frayed 2 2
Difficult to Fold, Unfold or Collapse 2 2
Mechanical Problem 2 2
Incorrect Measurement 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
Fluid/Blood Leak 1 1
Entrapment of Device 1 1
Collapse 1 1
Solder Joint Fracture 1 1
Defective Device 1 1
Improper or Incorrect Procedure or Method 1 1
Material Perforation 1 1
High Readings 1 1
Structural Problem 1 1
Failure to Advance 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1457 1457
No Known Impact Or Consequence To Patient 967 967
Thrombosis/Thrombus 222 222
Stenosis 188 188
Intracranial Hemorrhage 184 184
Stroke/CVA 156 156
Death 101 101
Thrombosis 92 92
Obstruction/Occlusion 86 86
Headache 86 86
Therapeutic Response, Decreased 81 81
Neurological Deficit/Dysfunction 75 75
Muscle Weakness 60 60
Hemorrhage/Bleeding 59 59
Paresis 59 59
No Consequences Or Impact To Patient 58 58
Thromboembolism 57 57
Ischemia 54 54
Infarction, Cerebral 52 52
Unspecified Nervous System Problem 52 52
Ischemia Stroke 48 48
Visual Disturbances 47 47
Paralysis 47 47
Transient Ischemic Attack 45 45
Vasoconstriction 44 44
Insufficient Information 42 42
Rupture 40 40
Fistula 39 39
Dysphasia 38 38
Occlusion 37 37
Hematoma 36 36
Aneurysm 34 34
Hemorrhage, Subarachnoid 34 34
Vascular Dissection 32 32
Loss of Vision 30 30
Thrombus 29 29
Swelling/ Edema 29 29
Visual Impairment 27 27
Foreign Body In Patient 25 25
Device Embedded In Tissue or Plaque 24 24
Speech Disorder 23 23
Hydrocephalus 22 22
Hemorrhage, Cerebral 22 22
Nausea 19 19
Blurred Vision 19 19
Perforation of Vessels 18 18
Pain 16 16
Ruptured Aneurysm 16 16
Perforation 14 14
Pseudoaneurysm 14 14
Convulsion/Seizure 12 12
Embolus 12 12
Cognitive Changes 11 11
Embolism/Embolus 11 11
Loss of consciousness 10 10
Therapeutic Effects, Unexpected 10 10
Dizziness 10 10
High Blood Pressure/ Hypertension 9 9
Low Blood Pressure/ Hypotension 9 9
Discomfort 8 8
Numbness 8 8
Syncope/Fainting 8 8
Cerebral Edema 8 8
Confusion/ Disorientation 7 7
Brain Injury 7 7
Nerve Damage 7 7
Edema 7 7
Bradycardia 6 6
Hypersensitivity/Allergic reaction 6 6
Neuropathy 6 6
Unspecified Infection 6 6
Memory Loss/Impairment 6 6
Dyskinesia 6 6
Tachycardia 6 6
Seizures 6 6
No Information 6 6
Shaking/Tremors 5 5
Hyperplasia 5 5
No Patient Involvement 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Renal Failure 4 4
Cardiac Arrest 4 4
Arrhythmia 4 4
Foreign Body Reaction 4 4
No Code Available 4 4
Hemorrhagic Stroke 4 4
Movement Disorder 3 3
Paraplegia 3 3
Lethargy 3 3
Granuloma 3 3
Fatigue 3 3
Feeding Problem 3 3
Emotional Changes 3 3
Dysphagia/ Odynophagia 3 3
Pulmonary Embolism 3 3
Anemia 3 3
Coagulation Disorder 3 3
Bacterial Infection 3 3
Hemorrhage, Intraventricular 3 3
Eye Pain 3 3

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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