It was reported that after the completion of a left transcarotid artery revascularization (tcar) procedure, the patient experienced a stroke.It was also reported that the patient experienced systolic blood pressure below 100mm post procedure, before the stroke event.Imaging revealed that the stent was occluded at the distal end of the left internal carotid artery (ica).The physician performed carotid endarterectomy (cea) and thrombectomy.The stent was explanted.At this time, it is unknown if the patient's symptoms have resolved.At this time, it is unknown if the reported event is related to procedural issues, patient resistance 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.At this time, it is unknown if the reported event is related to procedural issues, patient resistance 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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