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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)
2015 2016 2017 2018 2019 2020
1 1 1 7 5 4

MDR Year MDR Reports MDR Events
2015 562 562
2016 540 540
2017 448 448
2018 425 425
2019 527 527
2020 479 479

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 1429 1429
Adverse Event Without Identified Device or Use Problem 910 910
Break 227 227
Positioning Failure 147 147
Physical Resistance/Sticking 115 115
Migration or Expulsion of Device 96 96
Activation, Positioning or SeparationProblem 75 75
Detachment of Device or Device Component 53 53
Migration 51 51
Physical Resistance 48 48
Material Deformation 44 44
Difficult to Open or Close 33 33
Retraction Problem 30 30
No Apparent Adverse Event 24 24
Positioning Problem 23 23
Appropriate Term/Code Not Available 14 14
Difficult To Position 13 13
Unintended Movement 11 11
Difficult or Delayed Activation 10 10
Unintended Ejection 8 8
Fracture 8 8
Difficult to Remove 8 8
Insufficient Information 8 8
Material Separation 7 7
Premature Activation 7 7
Malposition of Device 7 7
Flaked 7 7
Premature Separation 7 7
Delamination 6 6
Device Operates Differently Than Expected 5 5
Material Twisted/Bent 5 5
Activation Problem 5 5
Difficult or Delayed Positioning 5 5
Wire 4 4
Detachment Of Device Component 4 4
Occlusion Within Device 4 4
Deformation Due to Compressive Stress 4 4
Stent 4 4
Mechanical Problem 4 4
Component or Accessory Incompatibility 3 3
Tip 3 3
Mechanical Jam 3 3
Peeled/Delaminated 3 3
Restricted Flow rate 3 3
Difficult to Fold, Unfold or Collapse 2 2
Material Frayed 2 2
Inadequacy of Device Shape and/or Size 2 2
Kinked 2 2
Improper or Incorrect Procedure or Method 2 2
Catheter 2 2
Device Dislodged or Dislocated 2 2
Patient-Device Incompatibility 2 2
Collapse 2 2
Stretched 2 2
Use of Device Problem 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
Incorrect Measurement 1 1
Communication or Transmission Problem 1 1
Device Slipped 1 1
Defective Device 1 1
Device Damaged by Another Device 1 1
Solder Joint Fracture 1 1
High Readings 1 1
Device Inoperable 1 1
Difficult to Advance 1 1
Incorrect Device Or Component Shipped 1 1
Difficult to Insert 1 1
Component Falling 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1699 1699
Therapeutic Response, Decreased 187 187
Thrombosis 173 173
Death 168 168
Intracranial Hemorrhage 154 154
Infarction, Cerebral 145 145
Neurological Deficit/Dysfunction 137 137
Occlusion 102 102
No Consequences Or Impact To Patient 97 97
Stenosis 67 67
Hemorrhage, Cerebral 63 63
Hemorrhage, Subarachnoid 61 61
Paresis 53 53
Thromboembolism 49 49
Ischemia 45 45
Fistula 44 44
Hemorrhage/Bleeding 39 39
Foreign Body In Patient 39 39
Stroke/CVA 30 30
Thrombus 30 30
Visual Disturbances 28 28
Vasoconstriction 27 27
Hematoma 27 27
Headache 26 26
Visual Impairment 26 26
Device Embedded In Tissue or Plaque 25 25
Rupture 25 25
Vascular Dissection 24 24
Transient Ischemic Attack 22 22
Failure of Implant 20 20
Aneurysm 19 19
Perforation 19 19
Edema 17 17
Dysphasia 16 16
Paralysis 15 15
Hydrocephalus 14 14
Seizures 12 12
Loss of Vision 12 12
Embolus 12 12
Perforation of Vessels 12 12
Therapeutic Effects, Unexpected 10 10
Muscle Weakness 9 9
Intimal Dissection 9 9
Foreign Body Reaction 8 8
Nerve Damage 8 8
No Code Available 8 8
No Patient Involvement 7 7
No Information 7 7
Brain Injury 7 7
Pain 7 7
Dizziness 3 3
Embolism 3 3
Paraplegia 3 3
Neuropathy 3 3
Hemorrhage, Intraventricular 3 3
Loss of consciousness 3 3
Numbness 3 3
Seizures, Focal 2 2
Quadriplegia 2 2
Coma 2 2
Cognitive Changes 2 2
High Blood Pressure/ Hypertension 2 2
Inflammation 2 2
Air Embolism 2 2
Encephalopathy 2 2
Memory Loss/Impairment 2 2
Pseudoaneurysm 2 2
Facial Nerve Paralysis 2 2
Arrhythmia 2 2
Weakness 2 2
Tachycardia 2 2
Blurred Vision 2 2
Hemorrhage, Subdural 1 1
Nausea 1 1
Burning Sensation 1 1
Optical Nerve Damage 1 1
Cardiac Arrest 1 1
Apheresis 1 1
Deafness 1 1
Ecchymosis 1 1
Hair Loss 1 1
Eye Injury 1 1
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Loss Of Pulse 1 1
Injury 1 1
Loss of Range of Motion 1 1
Swelling 1 1
Vertigo 1 1
Vitreous Hemorrhage 1 1
Extravasation 1 1
Fatigue 1 1
Hearing Impairment 1 1
Calcium Deposits/Calcification 1 1
Chemosis 1 1
Dementia 1 1
Vessel Or Plaque, Device Embedded In 1 1
Lethargy 1 1
Ambulation Difficulties 1 1
Collapse 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Mar-09-2020
2 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
3 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Oct-14-2015
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