The product associated with this complaint was not returned to the manufacturer for analysis.A review of the 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 a silk road medical device failure, hence, the event will be reported out of 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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It was reported that after completion of a right transcarotid artery revascularization (tcar) procedure, imaging revealed a thrombosed stent.The physician performed carotid endarterectomy (cea) to address the issue.At this time, it is unknown if the reported event 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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