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.At this time, it is unknown if the reported failure is related to procedural issues, non-compliance 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 and a supplemental mdr will be submitted if additional information is received.B3 field: the exact date of the event is unknown and has been capatured based on the decription provided in b5.
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It was reported that three weeks after a transcarotid artery revascularization (tcar) procedure, the patient had a stroke.Imaging revealed thrombus within the stent.The physician performed thrombectomy to address the issue.At this time, it is unknown if the reported failure is related to procedural issues, non-compliance to medication, or a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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