The product associated with this complaint was not returned to the manufacturer for analysis.A review of 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 failure is related to procedural issues, medication non-compliance/resistance, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.Silk road medical will continue to monitor for occurrences of similar events.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 after the completion of a right transcarotid artery revascularization (tcar) procedure, the patient had an embolic stroke, experiencing left hand/arm weakness.Imaging performed revealed an infarct in the right posterior occipital/ parietal region.The patient regained 80% of movement in their left arm/hand and there was no medical or surgical intervention performed due to the stroke event.There were no blood pressure management issues noted and no p2y12 inhibitor test performed on this patient.At this time, it is unknown if the reported failure is related to procedural issues, medication non-compliance/resistance, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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