A secondary mdr was reported under 3014526664-2024-00040 as there were two products associated with this event.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.As the reported event may related to procedural issues or the enroute transcarotid neuroprotection system nps), 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.
|
It was reported that after a left transcarotid artery revascularization (tcar) procedure, the patient was aphasic and had an ischemic stroke.Imaging revealed left sided scattered acute infarcts (new white lesions) and low density material within the enroute stent that could be potentially thrombus.The patient's symptoms have not yet resolved and no additional intervention was performed.As the reported event may related to procedural issues or the enroute transcarotid neuroprotection system nps), the event will be reported out of abundance of caution.
|