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 to medication, 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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It was reported that two days after a left transcarotid artery revascularization (tcar) procedure, the patient experienced left sided visual changes with progressive right sided weakness.Imaging performed revealed an occluded stent at the common carotid artery.The patient was switched from clopidogrel to brillinta and integrilin.A p2y12 resistance test was not performed since the patient was already administered brillinta and there is no conclusive evidence if the patient was plavix resistant.Per the physician, the patient is doing much better and their stroke symptoms are resolving.At this time, it is unknown if the reported failure is related to procedural issues, patient resistance to medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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