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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device polymerizing, neurovascular embolization material
Definition The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ.
Product CodeOBA
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2015 14 14
2018 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Migration or Expulsion of Device 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Neurological Deficit/Dysfunction 4 4
No Known Impact Or Consequence To Patient 4 4
Optical Nerve Damage 2 2
Infarction, Cerebral 2 2
Blurred Vision 2 2
Visual Disturbances 1 1
Dyskinesia 1 1
Foreign Body In Patient 1 1
Edema 1 1
Macular Edema 1 1
Facial Nerve Paralysis 1 1
Hemorrhage/Bleeding 1 1
Sepsis 1 1
Stroke/CVA 1 1

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