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 event is related to patient's underlying condition, 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 post right transcarotid artery revascularization (tcar) procedure, the patient developed stroke symptoms, such as left hand numbness and loss of dexterity.Imaging revealed right cortical infarcts.The patient also developed bradycardia for about 24 hours which had improved, however there were recurring pauses on telemetry leading to pacemaker placement.The physician indicated that the pauses on telemetry were unrelated to a tcar procedure.At this time, it is unknown if the reported event is related to patient's underlying condition, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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