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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