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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)
2019 2020 2021 2022 2023 2024
5 9 13 7 8 11

MDR Year MDR Reports MDR Events
2019 527 527
2020 809 809
2021 850 850
2022 1118 1118
2023 1186 1186
2024 853 853

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 2855 2855
Adverse Event Without Identified Device or Use Problem 1429 1429
Physical Resistance/Sticking 828 828
Material Deformation 569 569
Break 244 244
Activation, Positioning or Separation Problem 228 228
Unintended Movement 220 220
Migration 161 161
Retraction Problem 110 110
Positioning Failure 107 107
Unintended Ejection 87 87
No Apparent Adverse Event 74 74
Premature Activation 73 73
Material Twisted/Bent 58 58
Difficult to Remove 49 49
Deformation Due to Compressive Stress 48 48
Material Frayed 44 44
Structural Problem 40 40
Detachment of Device or Device Component 39 39
Activation Problem 36 36
Difficult or Delayed Activation 34 34
Malposition of Device 32 32
Fracture 31 31
Improper or Incorrect Procedure or Method 28 28
Device Dislodged or Dislocated 28 28
Material Separation 28 28
Premature Separation 22 22
Difficult or Delayed Positioning 15 15
Collapse 12 12
Difficult to Open or Close 11 11
Positioning Problem 11 11
Lack of Effect 10 10
Appropriate Term/Code Not Available 9 9
Stretched 9 9
Component or Accessory Incompatibility 8 8
Difficult or Delayed Separation 7 7
Insufficient Information 6 6
Component Missing 5 5
Patient-Device Incompatibility 5 5
Migration or Expulsion of Device 5 5
Use of Device Problem 4 4
Off-Label Use 4 4
Entrapment of Device 4 4
Device Damaged by Another Device 3 3
Packaging Problem 3 3
Material Integrity Problem 3 3
Obstruction of Flow 2 2
Separation Failure 2 2
Difficult to Fold, Unfold or Collapse 2 2
Flushing Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2817 2817
No Known Impact Or Consequence To Patient 707 707
Thrombosis/Thrombus 363 363
Stenosis 307 307
Intracranial Hemorrhage 242 242
Stroke/CVA 220 220
Obstruction/Occlusion 182 182
Headache 158 158
Ischemia Stroke 134 134
Unspecified Nervous System Problem 112 112
Aneurysm 109 109
Hemorrhage/Bleeding 103 103
Muscle Weakness 94 94
Paresis 94 94
Ischemia 90 90
Vasoconstriction 85 85
Visual Disturbances 82 82
Death 79 79
Insufficient Information 79 79
Transient Ischemic Attack 70 70
Thromboembolism 69 69
Paralysis 69 69
Dysphasia 66 66
Failure of Implant 66 66
Rupture 65 65
Therapeutic Response, Decreased 57 57
Vascular Dissection 55 55
Hematoma 53 53
No Consequences Or Impact To Patient 50 50
Foreign Body In Patient 45 45
Thrombosis 45 45
Neurological Deficit/Dysfunction 44 44
Fistula 44 44
Visual Impairment 41 41
Speech Disorder 41 41
Swelling/ Edema 41 41
Blurred Vision 39 39
Loss of Vision 39 39
Infarction, Cerebral 34 34
Ruptured Aneurysm 33 33
Hydrocephalus 31 31
Cognitive Changes 31 31
Nausea 30 30
Pain 27 27
Hemorrhagic Stroke 27 27
Perforation of Vessels 26 26
Device Embedded In Tissue or Plaque 25 25
Numbness 25 25
Hemorrhage, Subarachnoid 25 25
Pseudoaneurysm 24 24

Recalls
Manufacturer Recall Class Date Posted
1 MICROVENTION INC. II Jul-27-2023
2 Micro Therapeutics Inc, I Sep-03-2021
3 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Mar-09-2020
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