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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agent, injectable, embolic
Product CodeMFE
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
3 1 1 5 0 3

MDR Year MDR Reports MDR Events
2021 150 150
2022 176 176
2023 433 433
2024 248 248
2025 177 177
2026 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 613 613
Detachment of Device or Device Component 161 161
Migration or Expulsion of Device 147 147
Burst Container or Vessel 77 77
Physical Resistance/Sticking 73 73
Entrapment of Device 70 70
Break 62 62
Leak/Splash 58 58
Display or Visual Feedback Problem 43 43
Compatibility Problem 33 33
Unintended Movement 32 32
Material Deformation 30 30
Difficult to Remove 29 29
Packaging Problem 28 28
Difficult to Advance 20 20
Chemical Problem 18 18
No Apparent Adverse Event 16 16
Premature Activation 14 14
Device Damaged by Another Device 13 13
Separation Failure 11 11
Use of Device Problem 9 9
Expiration Date Error 7 7
Improper Chemical Reaction 7 7
Labelling, Instructions for Use or Training Problem 7 7
Malposition of Device 5 5
Fluid/Blood Leak 5 5
Product Quality Problem 4 4
Incomplete or Missing Packaging 3 3
Stretched 3 3
Device Dislodged or Dislocated 3 3
Retraction Problem 3 3
Inaccurate Information 3 3
Improper or Incorrect Procedure or Method 2 2
Deformation Due to Compressive Stress 2 2
Material Separation 2 2
Fracture 2 2
Appropriate Device Problem Term/Code Not Available 2 2
Sparking 1 1
Material Rupture 1 1
Free or Unrestricted Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Excess Flow or Over-Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 444 444
Foreign Body In Patient 182 182
Intracranial Hemorrhage 148 148
Hemorrhage/Blood Loss/Bleeding 98 98
Unspecified Nervous System Problem 81 81
Hematoma 65 65
Insufficient Information 62 62
Obstruction/Occlusion 62 62
Headache 54 54
Ischemia 53 53
Stroke/CVA 53 53
Ischemia Stroke 50 50
Fistula 49 49
Convulsion/Seizure 41 41
Rupture 40 40
Device Embedded In Tissue or Plaque 39 39
Muscle Weakness/Atrophy 38 38
Swelling/ Edema 37 37
Cognitive Changes 34 34
Paralysis 29 29
Vasoconstriction 29 29
Thrombosis/Thrombus 28 28
Paresis 28 28
Dysphasia 25 25
Vascular Dissection 25 25
Pain 24 24
Confusion/ Disorientation 22 22
Visual Disturbances 22 22
Nerve Damage 22 22
Perforation of Vessels 20 20
Unspecified Infection 20 20
Nervous System Injury 16 16
Bacterial Infection 15 15
Pulmonary Embolism 15 15
Hydrocephalus 15 15
Embolism/Embolus 14 14
Hemorrhagic Stroke 13 13
Visual Impairment 13 13
Failure of Implant 13 13
Necrosis 12 12
Facial Paralysis 12 12
Abscess 11 11
Pseudoaneurysm 11 11
Clinical Endoleak 11 11
Aneurysm 10 10
Thromboembolism 10 10
Blurred Vision 10 10
Cyst(s) 9 9
Cardiac Arrest 9 9
Nausea 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics, Inc. II Mar-04-2024
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