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 stent compression and stroke symptoms are related to patient's resistance to medication/non-compliance or a silk road medical device failure, hence, the events will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.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 9 days after a right transcarotid artery revascularization (tcar) procedure, the patient experienced mild left arm weakness.The symptoms have not yet resolved.Imaging revealed stent was ovalized (compressed) and a dissection was identified in the distal internal carotid artery (ica).The physician did not indicate which device caused the dissection and no additional intervention was performed to treat the dissection.At this time, it is unknown if the reported stent compression and stroke symptoms are related to patient's resistance to medication/non-compliance or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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