Only the deployment catheter of the wirion embolic protection device was received for analysis.As the filter of the device was not returned for analysis, the results of the investigation are inconclusive.Based on the information received, the cause of the reported event could not be conclusively determined.The material inspection report for this guide wire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id# (b)(4).
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A wirion embolic protection device was selected for use during treatment of a moderately calcified, 70% stenosed lesion in the superficial femoral artery.The filter was deployed in the popliteal artery.Laser atherectomy was performed, and embolization of lesion debris occurred.The filter had moved 5-10mm during treatment of the sfa lesion, and the emboli was observed in the distal posterior tibial artery.In the opinion of the physician, the filter movement contributed to the distal embolization.The embolization was treated with balloon angioplasty, and the patient was comfortable with slight ankle pain following the procedure.The ankle pain resolved, and the patient was discharged home.
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