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 or 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.A supplemental mdr will be submitted if additional information is received.
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It was reported that 5 days after a transcarotid artery revascularization (tcar) procedure, the patient had aphasia.Imaging reveled that the stent was occluded/thrombosed.No p2y12 inhibitor testing results were provided.At this time, it is unknown if the reported event is related to procedural issues, patient resistance or 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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