It was reported that during a transcarotid artery revascularization (tcar) procedure, resistance was met during stent deployment, and a filling defect was noticed on the left internal carotid artery after stent placement which led the physician to place a secondary stent to resolve.It was also reported to silk road medical that the patient had mural thrombus in the left internal carotid artery measuring over 1 cm in diameter.After the completion of the tcar procedure, the final angiogram showed minimal residual defect and the intravascular ultrasound (ivus) showed no apparent intraluminal debris, however the patient demonstrated stroke symptoms that did not resolve within 24 hours.The event of plaque prolapse is likely with any stenting procedure based on the patients physiology and is not related to the silk road medical device.At this time it is unknown if the stroke was related to the patient condition or a product problem.
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The product associated with this complaint was not returned to the manufacturer for analysis.A review of manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.Although there is no indication that a malfunction of the srm device occurred, the cause of the post-operative complications unknown, and therefore will be reported out of an abundance of caution.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
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