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; the cause of the post-operative complication is unknown, therefore, the complaint will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.A supplemental mdr will be submitted if additional information is received.
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It was reported that two hours after the completion of right transcarotid artery revascularization (tcar) procedure, the patient suffered a thrombotic stroke.The patient experienced paralysis and loss of function at the left side and was on intubation.A computed tomography (ct) scan was performed which revealed the stent was thrombosed.The physician believed that this could be related to patient's resistance to plavix, however there was no conclusive evidence if the patient was plavix resistant.At this time, it is unknown if the reported failure is related to a enroute transcarotid stent system (tss) failure or patient resistance to medication, hence, the event will be reported out of abundance of caution.
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