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.It is unknown whether the reported failure is related to a silk road medical device failure, patient resistance to medication, or a recrudescence of an original event, hence, the event will be reported out of abundance of caution.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
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It was reported that after the completion of a left transcarotid artery revascularization (tcar) procedure, the patient suffered a stroke.The patient experienced symptoms for 1-2 days and computed tomography angiography (cta) imaging revealed an embolic event.No intervention was performed as a result of the event.No p2y12 inhibitor testing has been performed on this patient.At this time, it is unknown if the reported failure is related to a silk road medical device failure, patient resistance to medication, or a recrudescence of an original event.Hence, the event will be reported out of abundance of caution.
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