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 procedural issues, patient resistance to medication or is 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 after the completion of a left transcarotid artery revascularization (tcar) procedure, the patient had a stroke and experienced stroke symptoms such as aphasia, inability to move right extremities and look to the right.Imaging revealed no issues with the stent.The patient's symptoms have not yet resolved, and no additional intervention performed.At this time, it is unknown if the reported failure is related to procedural issues, patient resistance to medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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