It was reported that after the transaortic artery revascularization (tcar) procedure, a stent thrombosis was observed leading to expressive aphasia.The physician removed the thrombosed stent via open surgical intervention.The patient was reported to be doing better after the incident.At this time, it is unknown if the event is related to procedural issues, patient resistance to dual anti-platelet therapy (dapt) medication, or a silk road medical device failure; however, 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 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; the cause of the post-operative complication is unknown, therefore, the complaint 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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