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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 5

MDR Year MDR Reports MDR Events
2020 809 809
2021 850 850
2022 1118 1118
2023 1186 1186
2024 1327 1327
2025 858 858

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 3253 3253
Adverse Event Without Identified Device or Use Problem 1595 1595
Physical Resistance/Sticking 1064 1064
Material Deformation 817 817
Activation, Positioning or Separation Problem 366 366
Unintended Movement 310 310
Retraction Problem 243 243
Break 210 210
Migration 184 184
Positioning Failure 138 138
Unintended Ejection 119 119
Structural Problem 111 111
Material Frayed 99 99
Material Twisted/Bent 98 98
Premature Activation 94 94
Deformation Due to Compressive Stress 93 93
No Apparent Adverse Event 81 81
Difficult to Remove 62 62
Device Dislodged or Dislocated 53 53
Improper or Incorrect Procedure or Method 42 42
Malposition of Device 42 42
Material Separation 40 40
Activation Problem 36 36
Detachment of Device or Device Component 34 34
Fracture 33 33
Collapse 30 30
Difficult or Delayed Activation 27 27
Difficult to Open or Close 26 26
Premature Separation 22 22
Difficult or Delayed Positioning 20 20
Use of Device Problem 16 16
Lack of Effect 15 15
Stretched 10 10
Device Damaged by Another Device 8 8
Entrapment of Device 8 8
Appropriate Term/Code Not Available 8 8
Component or Accessory Incompatibility 7 7
Difficult or Delayed Separation 7 7
Component Missing 6 6
Insufficient Information 6 6
Packaging Problem 6 6
Patient-Device Incompatibility 6 6
Migration or Expulsion of Device 6 6
Positioning Problem 5 5
Material Integrity Problem 5 5
Difficult to Fold, Unfold or Collapse 4 4
Off-Label Use 4 4
Display or Visual Feedback Problem 3 3
Separation Failure 3 3
Device Stenosis 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3754 3754
Thrombosis/Thrombus 450 450
Stenosis 388 388
No Known Impact Or Consequence To Patient 361 361
Intracranial Hemorrhage 252 252
Stroke/CVA 231 231
Obstruction/Occlusion 229 229
Ischemia Stroke 213 213
Headache 199 199
Aneurysm 170 170
Unspecified Nervous System Problem 128 128
Hemorrhage/Bleeding 123 123
Muscle Weakness 113 113
Failure of Implant 110 110
Paresis 107 107
Visual Disturbances 100 100
Vasoconstriction 98 98
Insufficient Information 89 89
Ischemia 87 87
Paralysis 85 85
Transient Ischemic Attack 78 78
Dysphasia 76 76
Thromboembolism 72 72
Rupture 67 67
Hematoma 63 63
Vascular Dissection 61 61
Death 54 54
Swelling/ Edema 53 53
Ruptured Aneurysm 50 50
Speech Disorder 49 49
Hemorrhagic Stroke 49 49
Foreign Body In Patient 47 47
Blurred Vision 45 45
Visual Impairment 45 45
Numbness 43 43
Dizziness 42 42
Cognitive Changes 42 42
Loss of Vision 41 41
Fistula 38 38
Nausea 36 36
Hyperplasia 36 36
Pain 34 34
Hydrocephalus 33 33
Nervous System Injury 29 29
Therapeutic Response, Decreased 28 28
Pseudoaneurysm 26 26
Perforation of Vessels 26 26
Convulsion/Seizure 25 25
Cerebral Edema 25 25
Thrombosis 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
4 Micro Therapeutics, Inc. I Mar-05-2025
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