As reported through the article titled, "woven endobridge versus stent-assisted coil embolization of cerebral bifurcation aneurysms" a retrospective single-center study was performed that comprised of 63 bifurcation aneurysms that were treated endovascularly with web devices between 2011 and 2019.Of those 63 cases, 1 patient with an unruptured aneurysm measuring (4.2mm/dome x 2.7mm/neck) developed an asymptomatic thrombus formation, which was managed by an intra-arterial abciximab.The patient was reported to have complete resolution.
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The lot number was not provided; therefore, the device history records could not be reviewed and a lot history trending review could not be performed.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.Article bibliograph: el naamani, kareem, et al."woven endobridge versus stent-assisted coil embolization of cerebral bifurcation aneurysms." journal of neurosurgery 1.Aop (2022): 1-8.
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