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.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.At this time, it is unknown if the reported failure is related to the enroute nps, which may have caused or contributed to the patient experiencing a serious injury, patient resistance to medication, or a recrudescence of an original event.Hence, the event will be reported out of abundance of caution.At this time, the expiration date is unable to be captured due to a technical glitch with esubmitter.The actual device expiration date shall be documented as 03/14/2025.
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It was reported that approximately one week after the completion of a transcarotid artery revascularization (tcar) procedure, the patient experienced an embolic stroke.The patients symptoms included leg weakness, which resolved within a couple of days.The patient was not tested for plavix resistance and has returned to baseline.At this time, it is unknown if the reported failure is related to the enroute neuroprotection system (nps), which may have caused or contributed to the patient experiencing a serious injury, patient resistance to medication, or a recrudescence of an original event.Hence, the event will be reported out of abundance of caution.
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