It was reported that after a left transcarotid artery revascularization (tcar) procedure, the patient experienced ischemic stroke and the stent had thrombosed.Imaging revealed some compression in stent.A thrombectomy was performed to address the issue.There was no p2y12 inhibitor test performed, and it is unknown if the patient's symptoms have completely resolved.At this time, it is unknown if the reported event is related to procedural issues, 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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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.There is no indication that a malfunction of the srm device occurred.Although imaging revealed some stent compression, it is unknown if the stent compression is what led to the formation of thrombus.It is also unknown what caused the stent compression.At this time, it is unknown if the reported event is related to procedural issues, 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.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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