The device lot number is unknown; therefore, a search for non-conformance's associated with the reported part/lot number combination could not be performed.The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies aneurysm perforation as complication associated with use of the device.
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As reported through the article titled, "woven endobridge embolized aneurysm clippings: 2-dimensional operative video ", during follow-up angiography, two patients were found to have sizable recurrent aneurysms after having been treated for their ruptured middle cerebral and anterior communicating artery aneurysms with the web device.Both patient's underwent surgical clip occlusion.
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