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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 7

MDR Year MDR Reports MDR Events
2019 527 527
2020 809 809
2021 850 850
2022 1118 1118
2023 1186 1186
2024 645 645

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 2714 2714
Adverse Event Without Identified Device or Use Problem 1387 1387
Physical Resistance/Sticking 781 781
Material Deformation 517 517
Break 237 237
Activation, Positioning or Separation Problem 214 214
Unintended Movement 207 207
Migration 147 147
Positioning Failure 103 103
Retraction Problem 95 95
Unintended Ejection 75 75
No Apparent Adverse Event 73 73
Premature Activation 70 70
Material Twisted/Bent 48 48
Difficult to Remove 45 45
Deformation Due to Compressive Stress 42 42
Detachment of Device or Device Component 39 39
Activation Problem 35 35
Material Frayed 35 35
Difficult or Delayed Activation 34 34
Structural Problem 30 30
Malposition of Device 29 29
Fracture 29 29
Improper or Incorrect Procedure or Method 27 27
Material Separation 26 26
Device Dislodged or Dislocated 24 24
Premature Separation 21 21
Difficult or Delayed Positioning 13 13
Positioning Problem 11 11
Difficult to Open or Close 11 11
Appropriate Term/Code Not Available 9 9
Lack of Effect 9 9
Component or Accessory Incompatibility 8 8
Difficult or Delayed Separation 7 7
Collapse 7 7
Migration or Expulsion of Device 5 5
Component Missing 5 5
Patient-Device Incompatibility 5 5
Insufficient Information 5 5
Off-Label Use 4 4
Entrapment of Device 3 3
Device Damaged by Another Device 3 3
Material Integrity Problem 3 3
Packaging Problem 3 3
Separation Failure 2 2
Flushing Problem 2 2
Difficult to Fold, Unfold or Collapse 2 2
Stretched 2 2
Obstruction of Flow 2 2
Failure to Advance 1 1
Defective Device 1 1
Solder Joint Fracture 1 1
Material Perforation 1 1
Material Fragmentation 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Difficult to Insert 1 1
Fluid/Blood Leak 1 1
Display or Visual Feedback Problem 1 1
Difficult to Advance 1 1
No Flow 1 1
Device Contaminated During Manufacture or Shipping 1 1
Therapeutic or Diagnostic Output Failure 1 1
Separation Problem 1 1
Inaccurate Information 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 2671 2671
No Known Impact Or Consequence To Patient 707 707
Thrombosis/Thrombus 351 351
Stenosis 293 293
Intracranial Hemorrhage 237 237
Stroke/CVA 217 217
Obstruction/Occlusion 170 170
Headache 153 153
Ischemia Stroke 123 123
Unspecified Nervous System Problem 106 106
Aneurysm 104 104
Hemorrhage/Bleeding 98 98
Muscle Weakness 92 92
Paresis 91 91
Ischemia 89 89
Vasoconstriction 82 82
Death 79 79
Visual Disturbances 77 77
Insufficient Information 75 75
Paralysis 68 68
Thromboembolism 68 68
Transient Ischemic Attack 67 67
Dysphasia 65 65
Rupture 63 63
Therapeutic Response, Decreased 57 57
Vascular Dissection 54 54
Hematoma 51 51
No Consequences Or Impact To Patient 50 50
Failure of Implant 49 49
Thrombosis 45 45
Neurological Deficit/Dysfunction 44 44
Foreign Body In Patient 44 44
Fistula 43 43
Swelling/ Edema 41 41
Speech Disorder 40 40
Visual Impairment 40 40
Loss of Vision 39 39
Blurred Vision 39 39
Infarction, Cerebral 34 34
Ruptured Aneurysm 33 33
Hydrocephalus 31 31
Nausea 30 30
Cognitive Changes 30 30
Pain 27 27
Hemorrhagic Stroke 26 26
Hemorrhage, Subarachnoid 25 25
Device Embedded In Tissue or Plaque 25 25
Perforation of Vessels 25 25
Thrombus 24 24
Pseudoaneurysm 24 24
Numbness 23 23
Dizziness 22 22
Occlusion 21 21
Convulsion/Seizure 21 21
Cerebral Edema 20 20
Hemorrhage, Cerebral 17 17
Confusion/ Disorientation 16 16
Embolism/Embolus 16 16
Memory Loss/Impairment 15 15
Syncope/Fainting 14 14
Nervous System Injury 13 13
Nerve Damage 13 13
Hyperplasia 13 13
Loss of consciousness 13 13
Low Blood Pressure/ Hypotension 12 12
Embolus 12 12
Neuropathy 10 10
Therapeutic Effects, Unexpected 10 10
Paresthesia 10 10
Eye Pain 9 9
Dyskinesia 9 9
Discomfort 8 8
Perforation 8 8
Vomiting 8 8
Hypersensitivity/Allergic reaction 8 8
High Blood Pressure/ Hypertension 8 8
Fatigue 8 8
Movement Disorder 8 8
Arrhythmia 7 7
Bacterial Infection 7 7
Unspecified Infection 7 7
Tachycardia 7 7
Seizures 6 6
Bradycardia 6 6
Anemia 6 6
Edema 6 6
Cardiac Arrest 5 5
Foreign Body Reaction 5 5
Skin Discoloration 5 5
Brain Injury 5 5
Coma 5 5
Shaking/Tremors 5 5
Ptosis 5 5
No Patient Involvement 5 5
Paraplegia 4 4
Renal Failure 4 4
Granuloma 4 4
Inflammation 4 4
Myocardial Infarction 4 4
Coagulation Disorder 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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