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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 3 1 4 3 1 1 1 7 5 9 13 7 8 12

MDR Year MDR Reports MDR Events
2014 438 438
2015 562 562
2016 540 540
2017 448 448
2018 425 425
2019 527 527
2020 809 809
2021 850 850
2022 1118 1118
2023 1186 1186
2024 853 853

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 3806 3806
Adverse Event Without Identified Device or Use Problem 2147 2147
Physical Resistance/Sticking 845 845
Material Deformation 580 580
Break 372 372
Activation, Positioning or Separation Problem 303 303
Positioning Failure 252 252
Unintended Movement 222 222
Migration 167 167
Retraction Problem 118 118
Migration or Expulsion of Device 116 116
Difficult to Open or Close 109 109
Unintended Ejection 87 87
Difficult to Remove 82 82
Premature Activation 79 79
Material Twisted/Bent 79 79
No Apparent Adverse Event 75 75
Detachment of Device or Device Component 71 71
Device Operates Differently Than Expected 60 60
Physical Resistance 54 54
Insufficient Information 51 51
Deformation Due to Compressive Stress 51 51
Material Frayed 46 46
Malposition of Device 46 46
Material Separation 43 43
Positioning Problem 43 43
Structural Problem 41 41
Activation Problem 36 36
Fracture 36 36
Difficult or Delayed Activation 35 35
Device Dislodged or Dislocated 34 34
Improper or Incorrect Procedure or Method 33 33
Difficult or Delayed Positioning 27 27
Separation Failure 25 25
Appropriate Term/Code Not Available 25 25
Premature Separation 24 24
Collapse 22 22
Occlusion Within Device 21 21
Stretched 17 17
Difficult To Position 16 16
Lack of Effect 10 10
Mechanical Problem 9 9
Detachment Of Device Component 9 9
Failure to Advance 8 8
Flaked 8 8
Component or Accessory Incompatibility 8 8
Kinked 8 8
Difficult or Delayed Separation 7 7
Patient-Device Incompatibility 7 7
Delamination 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2817 2817
No Known Impact Or Consequence To Patient 1943 1943
Thrombosis/Thrombus 363 363
Stenosis 357 357
Intracranial Hemorrhage 347 347
Stroke/CVA 247 247
Death 232 232
Headache 197 197
Therapeutic Response, Decreased 195 195
Thrombosis 193 193
Obstruction/Occlusion 183 183
No Consequences Or Impact To Patient 171 171
Hemorrhage/Bleeding 158 158
Infarction, Cerebral 158 158
Aneurysm 155 155
Neurological Deficit/Dysfunction 151 151
Ischemia Stroke 136 136
Paresis 135 135
Occlusion 131 131
Ischemia 120 120
Unspecified Nervous System Problem 112 112
Thromboembolism 102 102
Visual Disturbances 99 99
Muscle Weakness 98 98
Vasoconstriction 97 97
Rupture 95 95
Paralysis 91 91
Hemorrhage, Subarachnoid 86 86
Failure of Implant 86 86
Transient Ischemic Attack 84 84
Insufficient Information 79 79
Foreign Body In Patient 78 78
Dysphasia 78 78
Fistula 77 77
Hematoma 75 75
Vascular Dissection 74 74
Hemorrhage, Cerebral 72 72
Visual Impairment 64 64
Loss of Vision 53 53
Device Embedded In Tissue or Plaque 44 44
Blurred Vision 42 42
Thrombus 41 41
Speech Disorder 41 41
Swelling/ Edema 41 41
Hydrocephalus 39 39
Pain 37 37
Nausea 36 36
No Code Available 35 35
Numbness 34 34
Ruptured Aneurysm 33 33

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, Dba Ev3 Neurovascular I Nov-09-2016
5 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Oct-14-2015
6 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Aug-23-2013
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