Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device intracranial aneurysm flow diverter
Definition Treatment of wide-necked and larger or giant intracranial aneurysms.
Product CodeOUT
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
9 13 7 8 14 10

MDR Year MDR Reports MDR Events
2020 809 810
2021 850 851
2022 1118 1119
2023 1186 1186
2024 1326 1326
2025 1487 1487

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 3650 3650
Adverse Event Without Identified Device or Use Problem 1673 1675
Physical Resistance/Sticking 1261 1261
Material Deformation 997 997
Activation, Positioning or Separation Problem 402 402
Retraction Problem 366 366
Unintended Movement 353 353
Break 227 227
Migration 203 203
Material Frayed 151 151
Positioning Failure 150 150
Unintended Ejection 148 148
Structural Problem 125 125
Material Twisted/Bent 121 121
Deformation Due to Compressive Stress 120 120
Premature Activation 107 107
No Apparent Adverse Event 85 85
Difficult to Remove 68 68
Improper or Incorrect Procedure or Method 57 57
Device Dislodged or Dislocated 57 57
Material Separation 51 51
Malposition of Device 45 45
Activation Problem 41 41
Detachment of Device or Device Component 37 38
Collapse 36 36
Fracture 35 35
Use of Device Problem 33 33
Difficult or Delayed Activation 27 27
Difficult to Open or Close 26 26
Premature Separation 24 24
Difficult or Delayed Positioning 22 22
Lack of Effect 16 16
Stretched 11 11
Entrapment of Device 10 10
Device Damaged by Another Device 10 10
Component or Accessory Incompatibility 9 9
Appropriate Term/Code Not Available 8 8
Off-Label Use 8 8
Patient-Device Incompatibility 8 8
Migration or Expulsion of Device 7 7
Difficult or Delayed Separation 7 7
Positioning Problem 6 6
Component Missing 6 6
Insufficient Information 6 6
Packaging Problem 6 6
Material Integrity Problem 5 5
Difficult to Fold, Unfold or Collapse 5 5
Patient Device Interaction Problem 4 4
Separation Failure 4 4
Display or Visual Feedback Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4269 4270
Thrombosis/Thrombus 477 477
Stenosis 408 408
No Known Impact Or Consequence To Patient 361 361
Intracranial Hemorrhage 267 267
Obstruction/Occlusion 247 247
Stroke/CVA 245 245
Ischemia Stroke 233 233
Headache 217 218
Aneurysm 188 188
Unspecified Nervous System Problem 129 130
Hemorrhage/Bleeding 126 127
Failure of Implant 125 125
Muscle Weakness 115 116
Paresis 113 113
Visual Disturbances 105 105
Vasoconstriction 103 103
Ischemia 92 92
Paralysis 91 91
Insufficient Information 90 90
Transient Ischemic Attack 86 86
Dysphasia 77 77
Thromboembolism 75 75
Vascular Dissection 70 70
Rupture 68 68
Hematoma 67 67
Foreign Body In Patient 59 59
Ruptured Aneurysm 55 55
Swelling/ Edema 54 54
Death 54 54
Hemorrhagic Stroke 53 53
Visual Impairment 51 51
Speech Disorder 50 50
Blurred Vision 46 46
Loss of Vision 45 45
Cognitive Changes 45 45
Dizziness 45 45
Numbness 44 44
Hyperplasia 42 42
Fistula 42 42
Pain 37 37
Nausea 36 37
Hydrocephalus 35 35
Nervous System Injury 32 32
Therapeutic Response, Decreased 28 28
Pseudoaneurysm 28 28
Perforation of Vessels 27 27
Embolism/Embolus 26 26
Cerebral Edema 26 26
Convulsion/Seizure 25 25

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, Dba Ev3 Neurovascular I Mar-09-2020
5 Micro Therapeutics, Inc. I Mar-05-2025
-
-