The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The device was implanted in the patient and was not returned to the manufacturer for evaluation.Additionally, post procedural images were not provided; therefore, the reported event cannot be confirmed.The ifu identifies ischemic stroke and neurologic deficits as potential complications associated with use of the device.
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As reported through the article titled, "endovascular treatment of small and very small intracranial aneurysms with a web device," post successful intracranial aneurysm treatment with either a sl 3 or a sl 3.5 web device (dates unknown), 2 patients were reported to have suffered a neurologic deficit, and dwi revealed small punctiform ischemic spots.The first patient was treated with abciximab, and dwi spots were located in the territory of the branch where the clot had been seen.In the second case, no intraoperative thromboembolic complications were depicted, and mr imaging revealed 4 dwi spots in the middle cerebral artery territory.Deficits were all completely regressive at the patients' discharge.
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