It was reported that the procedure was performed to treat a lesion in the left superficial femoral artery.An emboshield nav6 embolic protection system (eps) was deployed without issue, and laser atherectomy, multiple unspecified balloons, and multiple unspecified stents were used.There was a large amount of debris collected in the filter, and an embolism was noted.A non-abbott extraction catheter was used to aspirate and treat the thrombus.Another nav6 was used to successfully complete the procedure.There were no adverse patient sequelae but there was a clinically significant delay in the procedure.No additional information was provided.
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The device was returned for analysis.There were no anomalies noted on the returned filtration element.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of embolism is listed in the emboshield nav6 instructions for use (ifu) as a known adverse event potentially associated with carotid stents and embolic protection systems.Based on the case information, the reported embolism and delay in procedure appear to be related to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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