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 available for return to the manufacturer for analysis.Medical imaging was not available.Therefore, the reported event could not be confirmed.The instructions for use (ifu) identifies thromboembolic event and transient ischemic attack as potential complications associated with use of the device.Choi, jai ho, et al."a single flow re-direction endoluminal device for the treatment of large and giant anterior circulation intracranial aneurysms." yonsei medical journal 63.4 (2022): 349.
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As reported through the article titled, "a single flow re-direction endoluminal device for the treatment of large and giant anterior circulation intracranial aneurysms" published in yonsei medical journal, a patient that was treated with a fred for an unruptured aneurysm (diameter 10.1mm x neck size 9.8mm) at the mca (middle cerebral artery) between january 2018 and july 2020 experienced a thromboembolic complication (tia) on postoperative date 176.The patient recovered without neurological deficit.The patient was a responder to: aspirin and clopidogrel.
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