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Vascular surgery / Aging-associated diseases / Stroke / Vascular bypass / Subarachnoid hemorrhage / Aneurysm / Coronary artery bypass surgery / Cerebral infarction / Posterior cerebral artery / Medicine / Neurosurgery / Cerebrovascular diseases


Summary of Safety and Probable Benefit
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Company

Pediatric Advisory Committee H080005 Elana Inc. / Spectranetics / Elana Inc / /

Continent

Europe / /

Country

Netherlands / United States / /

Event

FDA Phase / /

IndustryTerm

leakage using saline solution / moderate adverse event likely device / postmarket medical device / arteriotomy site / stainless steel distal tip / likely device / energy / anastomosis site / literature search / /

MedicalCondition

strokes / Nonfatal stroke / aphasia / aneurysm / basilar aneurysm / ischemic stroke / Intra-operative subarachnoid hemorrhage / non-fatal strokes / intra-operative stroke / neurological status/exam Worsening speech difficulties Expressive aphasia Pulmonary / hematoma Hydrocephalus SAH Aneurysm bleeding Intracranial hemorrhage / hemiplegia / stroke Subdural/epidural / Non fatal stroke / hemiparesis / injury / fatal strokes / fast growing aneurysm / fever Intracerebral hemorrhage / illness / ataxia / non-fatal stroke / Brainstem infarction / bacteremia / tumors / superior sagital sinus Thrombosis / Left femoral and lower extremity DVT Aneurysm / hematoma Brain stem compression Thrombosis / frontal lobe Intracerebral hemorrhage / Increased brain swelling / pseudoaneurysm / subsequent stroke / aneurysms / intracranial pressure Brain infarction / congenital abnormality / skull base tumor / fatal stroke / fetal death / thrombosis cause nonfatal strokes / infection / Total Non fatal stroke / thrombus / peri-operative non-fatal stroke / massive brain edema tumor / thrombosis / nonfatal strokes / diffuse subarachnoid hemorrhage / /

MedicalTreatment

neurosurgery / surgery / embolization / catheter / Bypass / /

Organization

Clinical Events Committee / Center for Devices and Radiological Health / FDA / European Union / /

Position

responsible surgeon / Executive / representative / surgeon / /

Product

Elana Surgical KitHUD NOTE / Surgical KitHUD / H080005 / /

Technology

Laser System / Laser / neurosurgery / /

SocialTag