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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 2

MDR Year MDR Reports MDR Events
2019 527 527
2020 809 809
2021 850 850
2022 1118 1118
2023 1186 1186
2024 310 310

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 2535 2535
Adverse Event Without Identified Device or Use Problem 1301 1301
Physical Resistance/Sticking 725 725
Material Deformation 479 479
Break 231 231
Activation, Positioning or Separation Problem 195 195
Unintended Movement 189 189
Migration 143 143
Positioning Failure 96 96
Retraction Problem 77 77
Unintended Ejection 71 71
Premature Activation 67 67
No Apparent Adverse Event 65 65
Material Twisted/Bent 43 43
Detachment of Device or Device Component 39 39
Difficult to Remove 39 39
Difficult or Delayed Activation 31 31
Deformation Due to Compressive Stress 31 31
Activation Problem 30 30
Fracture 29 29
Improper or Incorrect Procedure or Method 23 23
Material Frayed 22 22
Malposition of Device 21 21
Material Separation 19 19
Premature Separation 19 19
Structural Problem 18 18
Difficult or Delayed Positioning 13 13
Device Dislodged or Dislocated 13 13
Positioning Problem 10 10
Difficult to Open or Close 10 10
Component or Accessory Incompatibility 8 8
Appropriate Term/Code Not Available 7 7
Insufficient Information 5 5
Component Missing 5 5
Migration or Expulsion of Device 5 5
Patient-Device Incompatibility 4 4
Difficult or Delayed Separation 4 4
Lack of Effect 3 3
Device Damaged by Another Device 3 3
Off-Label Use 3 3
Flushing Problem 2 2
Difficult to Fold, Unfold or Collapse 2 2
Entrapment of Device 2 2
Collapse 2 2
Obstruction of Flow 2 2
Separation Failure 2 2
Packaging Problem 2 2
Material Integrity Problem 2 2
No Flow 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Advance 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Stenosis 1 1
Extra Components 1 1
Separation Problem 1 1
Failure to Advance 1 1
Defective Device 1 1
Solder Joint Fracture 1 1
Material Perforation 1 1
Stretched 1 1
Fluid/Blood Leak 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2439 2439
No Known Impact Or Consequence To Patient 707 707
Thrombosis/Thrombus 339 339
Stenosis 278 278
Intracranial Hemorrhage 222 222
Stroke/CVA 213 213
Obstruction/Occlusion 153 153
Headache 143 143
Ischemia Stroke 106 106
Unspecified Nervous System Problem 98 98
Hemorrhage/Bleeding 86 86
Paresis 85 85
Muscle Weakness 82 82
Aneurysm 81 81
Death 79 79
Ischemia 79 79
Insufficient Information 74 74
Vasoconstriction 72 72
Visual Disturbances 71 71
Paralysis 66 66
Thromboembolism 66 66
Transient Ischemic Attack 62 62
Rupture 62 62
Therapeutic Response, Decreased 57 57
Dysphasia 55 55
No Consequences Or Impact To Patient 50 50
Hematoma 47 47
Thrombosis 45 45
Neurological Deficit/Dysfunction 44 44
Vascular Dissection 44 44
Fistula 42 42
Swelling/ Edema 40 40
Foreign Body In Patient 39 39
Visual Impairment 38 38
Loss of Vision 37 37
Speech Disorder 37 37
Blurred Vision 35 35
Infarction, Cerebral 34 34
Failure of Implant 30 30
Nausea 29 29
Hydrocephalus 28 28
Ruptured Aneurysm 28 28
Pain 26 26
Cognitive Changes 25 25
Hemorrhage, Subarachnoid 25 25
Thrombus 24 24
Device Embedded In Tissue or Plaque 24 24
Perforation of Vessels 23 23
Dizziness 21 21
Occlusion 21 21
Hemorrhagic Stroke 21 21
Convulsion/Seizure 21 21
Numbness 20 20
Pseudoaneurysm 18 18
Hemorrhage, Cerebral 17 17
Memory Loss/Impairment 15 15
Confusion/ Disorientation 14 14
Embolism/Embolus 14 14
Syncope/Fainting 13 13
Nerve Damage 13 13
Low Blood Pressure/ Hypotension 12 12
Embolus 12 12
Cerebral Edema 12 12
Hyperplasia 11 11
Loss of consciousness 11 11
Therapeutic Effects, Unexpected 10 10
Eye Pain 9 9
Paresthesia 8 8
Movement Disorder 8 8
Perforation 8 8
Discomfort 8 8
Dyskinesia 8 8
Hypersensitivity/Allergic reaction 8 8
High Blood Pressure/ Hypertension 8 8
Neuropathy 8 8
Fatigue 8 8
Arrhythmia 7 7
Unspecified Infection 7 7
Tachycardia 7 7
Vomiting 7 7
Seizures 6 6
Anemia 6 6
Bradycardia 6 6
Edema 6 6
Foreign Body Reaction 5 5
Brain Injury 5 5
Shaking/Tremors 5 5
No Patient Involvement 5 5
Nervous System Injury 5 5
Ptosis 4 4
Coma 4 4
Renal Failure 4 4
Fever 4 4
Inflammation 4 4
Myocardial Infarction 4 4
Coagulation Disorder 4 4
Extravasation 4 4
Bacterial Infection 4 4
Aphonia 4 4
Cerebral Hyperperfusion Syndrome 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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