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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)
2019 2020 2021 2022 2023 2024
2 0 0 0 2 2

MDR Year MDR Reports MDR Events
2019 7 7
2020 12 12
2021 10 10
2022 5 5
2023 7 7
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 39 39
Chemical Problem 6 6
Delivered as Unsterile Product 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Stroke/CVA 4 4
Headache 4 4
Embolism/Embolus 3 3
Embolism 3 3
Ischemia Stroke 3 3
Infarction, Cerebral 2 2
Neurological Deficit/Dysfunction 2 2
Intracranial Hemorrhage 2 2
Nerve Damage 2 2
Convulsion/Seizure 2 2
Ruptured Aneurysm 2 2
Hemorrhage/Bleeding 2 2
Thromboembolism 2 2
Low Blood Pressure/ Hypotension 2 2
Unspecified Infection 1 1
Death 1 1
Vascular Dissection 1 1
Hematoma 1 1
Ischemia 1 1
Muscle Weakness 1 1
Edema 1 1
Confusion/ Disorientation 1 1
Paralysis 1 1
Visual Disturbances 1 1
Thrombosis/Thrombus 1 1
Hemorrhage, Intraventricular 1 1
Urinary Retention 1 1
Hydrocephalus 1 1
Perforation of Vessels 1 1
Aneurysm 1 1
Hemorrhage, Subarachnoid 1 1
No Consequences Or Impact To Patient 1 1
Respiratory Failure 1 1
Distress 1 1

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