A search for non-conformance's associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains implanted in the patient and procedure images were not provided; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies aphasia, stent thrombosis, as potential complications associated with use of the device.
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It was reported that the fred flow divert stent was implanted to treat an aneurysm in the left internal carotid artery.After four coils were implanted in the aneurysm with balloon assist, the fred was implanted with confirmed good apposition and the procedure was completed without post-ballooning.About two hours later, aphasia occurred and mri revealed an occlusion in the left internal carotid artery, which required emergency treatment.The thrombus in the stent was aspirated from the proximal side, but recanalization was not achieved completely and resulted in migration of the stent.The fred was retrieved with a snare and an embolization device from another manufacturer was implanted and the procedure was completed.The physician believes the patient will recover without any sequelae.
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