It was reported via a journal article that patient injury occurred.Patients were treated with carotid wallstents and other non-bsc stents.During the procedures, two patients experienced tia (transient ischemic attack) and one patient experienced intraparenchymal hemorrhage.Five patients experienced transient bradycardia related to carotid sinus stimulation.Within the first 30 days of stent placement, on patient experienced an acute ischemic stroke.At the one year follow up, two ipsilateral strokes were reported.
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Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.Literature citation: jimenez-gomez, e.(2014).Unprotected carotid artery stenting in symptomatic elderly patients: a single-center experience.Journal of neurointerventional surgery, 0:1-5.(b)(4).
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