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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 3

MDR Year MDR Reports MDR Events
2019 527 527
2020 809 809
2021 850 850
2022 1118 1118
2023 1186 1186
2024 447 447

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 2601 2601
Adverse Event Without Identified Device or Use Problem 1346 1346
Physical Resistance/Sticking 744 744
Material Deformation 483 483
Break 231 231
Activation, Positioning or Separation Problem 205 205
Unintended Movement 195 195
Migration 143 143
Positioning Failure 98 98
Retraction Problem 84 84
Unintended Ejection 71 71
Premature Activation 69 69
No Apparent Adverse Event 67 67
Material Twisted/Bent 45 45
Difficult to Remove 41 41
Detachment of Device or Device Component 39 39
Deformation Due to Compressive Stress 37 37
Activation Problem 31 31
Difficult or Delayed Activation 31 31
Fracture 29 29
Material Frayed 29 29
Improper or Incorrect Procedure or Method 27 27
Malposition of Device 26 26
Structural Problem 22 22
Material Separation 22 22
Premature Separation 19 19
Device Dislodged or Dislocated 17 17
Difficult or Delayed Positioning 13 13
Difficult to Open or Close 11 11
Positioning Problem 11 11
Component or Accessory Incompatibility 8 8
Appropriate Term/Code Not Available 7 7
Difficult or Delayed Separation 7 7
Collapse 6 6
Migration or Expulsion of Device 5 5
Component Missing 5 5
Lack of Effect 5 5
Insufficient Information 5 5
Off-Label Use 4 4
Patient-Device Incompatibility 4 4
Device Damaged by Another Device 3 3
Separation Failure 2 2
Material Integrity Problem 2 2
Packaging Problem 2 2
Obstruction of Flow 2 2
Flushing Problem 2 2
Difficult to Fold, Unfold or Collapse 2 2
Entrapment of Device 2 2
Fluid/Blood Leak 1 1
Display or Visual Feedback Problem 1 1
Material Fragmentation 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Difficult to Insert 1 1
Failure to Advance 1 1
Defective Device 1 1
Stretched 1 1
Solder Joint Fracture 1 1
Material Perforation 1 1
No Flow 1 1
Device Contaminated During Manufacture or Shipping 1 1
Difficult to Advance 1 1
Therapeutic or Diagnostic Output Failure 1 1
Separation Problem 1 1
Device Stenosis 1 1
Extra Components 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2521 2521
No Known Impact Or Consequence To Patient 707 707
Thrombosis/Thrombus 345 345
Stenosis 288 288
Intracranial Hemorrhage 234 234
Stroke/CVA 215 215
Obstruction/Occlusion 163 163
Headache 147 147
Ischemia Stroke 117 117
Unspecified Nervous System Problem 104 104
Hemorrhage/Bleeding 94 94
Aneurysm 91 91
Paresis 90 90
Ischemia 85 85
Muscle Weakness 84 84
Death 79 79
Vasoconstriction 77 77
Insufficient Information 74 74
Visual Disturbances 72 72
Paralysis 68 68
Thromboembolism 67 67
Transient Ischemic Attack 64 64
Rupture 62 62
Dysphasia 59 59
Therapeutic Response, Decreased 57 57
No Consequences Or Impact To Patient 50 50
Hematoma 50 50
Vascular Dissection 47 47
Thrombosis 45 45
Neurological Deficit/Dysfunction 44 44
Fistula 42 42
Foreign Body In Patient 42 42
Swelling/ Edema 40 40
Speech Disorder 39 39
Visual Impairment 39 39
Loss of Vision 39 39
Blurred Vision 37 37
Failure of Implant 37 37
Infarction, Cerebral 34 34
Ruptured Aneurysm 32 32
Hydrocephalus 31 31
Nausea 30 30
Pain 27 27
Cognitive Changes 27 27
Device Embedded In Tissue or Plaque 25 25
Hemorrhage, Subarachnoid 25 25
Hemorrhagic Stroke 25 25
Perforation of Vessels 24 24
Thrombus 24 24
Dizziness 22 22
Numbness 21 21
Occlusion 21 21
Convulsion/Seizure 21 21
Pseudoaneurysm 20 20
Cerebral Edema 19 19
Hemorrhage, Cerebral 17 17
Memory Loss/Impairment 15 15
Confusion/ Disorientation 15 15
Embolism/Embolus 15 15
Syncope/Fainting 14 14
Loss of consciousness 13 13
Nerve Damage 13 13
Low Blood Pressure/ Hypotension 12 12
Hyperplasia 12 12
Embolus 12 12
Therapeutic Effects, Unexpected 10 10
Dyskinesia 9 9
Neuropathy 9 9
Paresthesia 9 9
Eye Pain 9 9
Movement Disorder 8 8
Nervous System Injury 8 8
Hypersensitivity/Allergic reaction 8 8
High Blood Pressure/ Hypertension 8 8
Fatigue 8 8
Discomfort 8 8
Perforation 8 8
Tachycardia 7 7
Vomiting 7 7
Arrhythmia 7 7
Bacterial Infection 7 7
Unspecified Infection 7 7
Bradycardia 6 6
Anemia 6 6
Edema 6 6
Seizures 6 6
Brain Injury 5 5
Coma 5 5
Shaking/Tremors 5 5
Ptosis 5 5
No Patient Involvement 5 5
Foreign Body Reaction 5 5
Granuloma 4 4
Inflammation 4 4
Myocardial Infarction 4 4
Fever 4 4
Extravasation 4 4
Cardiac Arrest 4 4
Coagulation Disorder 4 4
Paraplegia 4 4

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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