It was reported that during a transcarotid artery revascularization (tcar) procedure, after arterial sheath placement, the physician noted an extravasation in the distal common carotid artery after the placement of the stent.The physician elected to deploy a secondary third party stent to cover the extravasation.The procedure was completed successfully and no additional issues were noted.
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The product associated with this complaint was not returned to the manufacturer for analysis as the device was implanted.At this time it is unknown if the reported failure is related to procedural/user error or a silk road medical device failure, hence, the event will be reported out of abundance of caution.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.Complaints will continue to be reviewed and monitored for trends.
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