A secondary mdr was reported under 3014526664-2023-00189 as there are two stents associated with the same event/patient.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 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 two weeks post transcarotid artery revascularization (tcar) procedure, the patient presented with stroke symtoms, including difficulty speaking and drooling and had a right hemispheric stroke.The physician determined that the stent required an angioplasty.The procedure was completed successfully and the patient's symptoms have completely resolved.At this time, it is unknown if the reported event 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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