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.At this time, it is unknown if the reported failure is related to procedural issues, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.Silk road medical will continue to monitor for occurrences of similar events.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.
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It was reported that one day after the completion of a transcarotid artery revascularization (tcar) procedure, the patient had trouble formulating words.Imaging revealed a small infarct in the left hemisphere.Additional information indicated that the patients's symtoms had not resolved yet.At this time, it is unknown if the reported event is related to procedural issues or is a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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