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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)
2021 2022 2023 2024 2025 2026
13 7 8 14 10 6

MDR Year MDR Reports MDR Events
2021 850 851
2022 1118 1119
2023 1186 1186
2024 1326 1326
2025 1643 1643
2026 1096 1096

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 4023 4023
Adverse Event Without Identified Device or Use Problem 1626 1628
Physical Resistance/Sticking 1513 1513
Material Deformation 1267 1267
Retraction Problem 586 586
Unintended Movement 436 436
Activation, Positioning or Separation Problem 424 424
Unintended Ejection 219 219
Material Frayed 214 214
Migration 211 211
Structural Problem 184 184
Positioning Failure 179 179
Break 172 172
Material Twisted/Bent 166 166
Deformation Due to Compressive Stress 142 142
Premature Activation 132 132
Improper or Incorrect Procedure or Method 124 124
Use of Device Problem 104 104
Difficult to Remove 97 97
No Apparent Adverse Event 84 84
Material Separation 71 71
Device Dislodged or Dislocated 64 64
Activation Problem 53 53
Malposition of Device 52 52
Collapse 52 52
Fracture 35 35
Premature Separation 26 26
Difficult to Open or Close 25 25
Detachment of Device or Device Component 25 25
Difficult or Delayed Positioning 23 23
Difficult or Delayed Activation 21 21
Lack of Effect 21 21
Component or Accessory Incompatibility 13 13
Device Damaged by Another Device 13 13
Stretched 12 12
Off-Label Use 12 12
Entrapment of Device 11 11
Difficult or Delayed Separation 10 10
Patient-Device Incompatibility 10 10
Migration or Expulsion of Device 9 9
Packaging Problem 8 8
Appropriate Device Problem Term/Code Not Available 7 7
Insufficient Device Problem Information 6 6
Patient Device Interaction Problem 5 5
Material Integrity Problem 5 5
Separation Failure 5 5
Inaccurate Information 4 4
Difficult to Advance 4 4
Display or Visual Feedback Problem 3 3
Component Missing 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5095 5095
Thrombosis/Thrombus 495 495
Stenosis 442 442
Obstruction/Occlusion 282 282
Ischemia Stroke 278 278
Intracranial Hemorrhage 237 237
Stroke/CVA 234 234
Aneurysm 229 229
Headache 222 223
Failure of Implant 133 133
Unspecified Nervous System Problem 127 128
Hemorrhage/Blood Loss/Bleeding 126 127
Muscle Weakness/Atrophy 124 125
Paresis 115 115
Visual Disturbances 101 101
Vasoconstriction 97 97
Paralysis 97 97
Insufficient Information 92 92
Ischemia 91 91
Dysphasia 83 83
Transient Ischemic Attack 83 83
Ruptured Aneurysm 72 72
Vascular Dissection 67 67
Foreign Body In Patient 67 67
Thromboembolism 63 63
Hematoma 61 61
Hemorrhagic Stroke 61 61
Rupture 59 59
Hyperplasia 57 57
Nervous System Injury 57 57
Speech Disorder 55 55
Blurred Vision 55 55
Swelling/ Edema 54 54
Dizziness 53 53
Numbness 50 50
Cognitive Changes 49 49
Visual Impairment 48 48
Loss of Vision 44 44
Nausea 42 43
Fistula 41 41
Hydrocephalus 38 38
Pain 37 37
Cerebral Edema 29 29
Embolism/Embolus 29 29
Pseudoaneurysm 28 28
Convulsion/Seizure 24 24
Memory Loss/Impairment 23 23
Paresthesia 23 23
Confusion/ Disorientation 23 23
Syncope/Fainting 23 23

Recalls
Manufacturer Recall Class Date Posted
1 MICROVENTION INC. II Oct-10-2025
2 MICROVENTION INC. II Jul-27-2023
3 Micro Therapeutics Inc, I Sep-03-2021
4 Micro Therapeutics, Inc. II Jul-22-2026
5 Micro Therapeutics, Inc. I Mar-05-2025
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