The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural or post procedural images were not provided; therefore, the reported events cannot be confirmed.The lot numbers were not provided; therefore, a search for production-related ncrs could not be performed.
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As reported through the article titled, "the woven endobridge for unruptured intracranial aneurysms: results in 95 aneurysms from a single center", approximately 6 months post treatment of the patient's aneurysm with a web device (date unknown), angiographic images showed that the (b)(6) year-old female patient was found to have a "neck remnant of 2mm" that was incompletely occluded and required retreatment.At 2 years post procedure, a repeat angiogram showed a further growing neck remnant to 3 mm.At that time, the decision was made to treat with a flow diverter to occlude the remnant.Six months post retreatment, the patient's angiogram showed good occlusion of the remnant and occlusion of the acom connection.
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