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, medication non-compliance/resistance, 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 after the successful completion of a left transcarotid artery revascularization (tcar) procedure, the patient suffered a stroke with right side paralysis and the stent was thrombosed.The physician performed a thrombectomy.There was no imaging available to silk road medical for review, no blood pressure management issues noted, and no p2y12 inhibitor test performed on this patient.At this time, it is unknown if the reported event 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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