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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tissue adhesive for use in embolization of brain arteriovenous malformations
Product CodeKGG
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 2 2 2 0

MDR Year MDR Reports MDR Events
2021 10 10
2022 5 5
2023 7 7
2024 6 6
2025 16 16
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 31 31
Chemical Problem 9 9
Improper or Incorrect Procedure or Method 7 7
Unexpected Color 3 3
Fluid/Blood Leak 2 2
Leak/Splash 1 1
Device Ingredient or Reagent Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Headache 6 6
Convulsion/Seizure 5 5
Stroke/CVA 4 4
Ischemia 3 3
Embolism/Embolus 3 3
Hemorrhage/Bleeding 3 3
Hematoma 2 2
Intracranial Hemorrhage 2 2
Thrombosis/Thrombus 2 2
Nerve Damage 2 2
Perforation of Vessels 2 2
Ruptured Aneurysm 2 2
Ischemia Stroke 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Necrosis 1 1
Vascular Dissection 1 1
Diminished Pulse Pressure 1 1
Obstruction/Occlusion 1 1
Confusion/ Disorientation 1 1
Paralysis 1 1
Visual Disturbances 1 1
Infiltration into Tissue 1 1
Thromboembolism 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Failure 1 1
Pulmonary Embolism 1 1
Distress 1 1

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