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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)
2020 2021 2022 2023 2024 2025
9 13 7 8 14 0

MDR Year MDR Reports MDR Events
2020 809 809
2021 850 850
2022 1118 1118
2023 1186 1186
2024 1334 1334

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 2812 2812
Adverse Event Without Identified Device or Use Problem 1434 1434
Physical Resistance/Sticking 871 871
Material Deformation 642 642
Unintended Movement 253 253
Activation, Positioning or Separation Problem 248 248
Break 194 194
Migration 163 163
Retraction Problem 132 132
Positioning Failure 105 105
Unintended Ejection 91 91
Premature Activation 75 75
Material Twisted/Bent 75 75
No Apparent Adverse Event 68 68
Structural Problem 64 64
Material Frayed 59 59
Deformation Due to Compressive Stress 59 59
Difficult to Remove 51 51
Device Dislodged or Dislocated 40 40
Malposition of Device 36 36
Material Separation 34 34
Activation Problem 33 33
Fracture 31 31
Detachment of Device or Device Component 31 31
Improper or Incorrect Procedure or Method 29 29
Difficult or Delayed Activation 27 27
Premature Separation 21 21
Collapse 20 20
Difficult to Open or Close 16 16
Difficult or Delayed Positioning 15 15
Lack of Effect 11 11
Stretched 9 9
Appropriate Term/Code Not Available 8 8
Difficult or Delayed Separation 7 7
Component or Accessory Incompatibility 6 6
Migration or Expulsion of Device 6 6
Insufficient Information 6 6
Packaging Problem 5 5
Device Damaged by Another Device 5 5
Component Missing 5 5
Positioning Problem 5 5
Patient-Device Incompatibility 5 5
Use of Device Problem 4 4
Off-Label Use 4 4
Entrapment of Device 4 4
Material Integrity Problem 3 3
Separation Failure 3 3
Obstruction of Flow 2 2
Defective Device 2 2
Difficult to Fold, Unfold or Collapse 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3141 3141
Thrombosis/Thrombus 406 406
No Known Impact Or Consequence To Patient 361 361
Stenosis 332 332
Intracranial Hemorrhage 227 227
Stroke/CVA 220 220
Obstruction/Occlusion 196 196
Headache 172 172
Ischemia Stroke 164 164
Aneurysm 128 128
Unspecified Nervous System Problem 123 123
Hemorrhage/Bleeding 110 110
Muscle Weakness 100 100
Paresis 99 99
Visual Disturbances 87 87
Failure of Implant 86 86
Vasoconstriction 84 84
Insufficient Information 83 83
Ischemia 80 80
Paralysis 73 73
Dysphasia 70 70
Thromboembolism 70 70
Transient Ischemic Attack 68 68
Rupture 63 63
Vascular Dissection 56 56
Death 54 54
Hematoma 54 54
Swelling/ Edema 45 45
Speech Disorder 42 42
Foreign Body In Patient 42 42
Blurred Vision 42 42
Visual Impairment 39 39
Ruptured Aneurysm 38 38
Loss of Vision 37 37
Hemorrhagic Stroke 36 36
Cognitive Changes 36 36
Fistula 35 35
Nausea 33 33
Dizziness 31 31
Numbness 31 31
Hydrocephalus 30 30
Pain 30 30
Therapeutic Response, Decreased 28 28
Pseudoaneurysm 24 24
Perforation of Vessels 24 24
Convulsion/Seizure 24 24
Thrombosis 24 24
No Consequences Or Impact To Patient 23 23
Infarction, Cerebral 23 23
Thrombus 23 23

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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