It was reported that shortly after the completion of a left transcarotid artery revascularization (tcar) procedure, the patient developed slight contralateral upper extremity weakness with facial droop.The symptoms were improving, however the patient was transferred to the intensive care unit (icu) and treated with tissue plasminogen activator (tpa), which led to hemorrhagic conversion, respiratory arrest, and death.The reported events of hemorrhagic conversion, respiratory arrest and death are not related to the tcar procedure.At this time, it is unknown if the reported event of upper extremity weakness/facial droop is related to procedural issues, medication non-compliance or is a silk road medical device failure, hence, the event will be reported out of abundance of caution.
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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, 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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