AXS CATALYST 7 .068IN ID X 125CM - CE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WHO WAS ADMITTED IN A COMA. CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) REVEALED LEFT ICA (INTERNAL CAROTID ARTERY) TERMINAL OCCLUSION, AND THE PHYSICIAN DECIDED TO PROCEED WITH ENDOVASCULAR TREATMENT. AFTER DELIVERING A LONG SHEATH TO THE TARGET POSITION, THE PHYSICIAN USED A SUBJECT DEVICE (THROMBUS ASPIRATION CATHETER) AND ADVANCED IT WITH A DELIVERY WIRE THROUGH A MICROCATHETER ACROSS THE OCCLUDED SEGMENT. A RETRIEVER STENT WAS THEN DEPLOYED. THE RETRIEVER STENT WAS PULLED BACK WITH A COMBINATION OF ASPIRATION AND RETRIEVAL, BUT NO THROMBUS WAS CAPTURED. THE PHYSICIAN PERFORMED A SECOND PASS; HOWEVER, AT THAT TIME THE MICROCATHETER WAS FOUND TO HAVE SIGNIFICANT KINKING. UPON INSPECTION, THE PROXIMAL END OF THE SUBJECT DEVICE WAS FOUND TO BE FRACTURED. THE PHYSICIAN THEN REQUESTED REPLACEMENT WITH A NEW ASPIRATION CATHETER OF THE SAME MODEL AND A NEW MICROCATHETER. AFTER REPLACEMENT, ASPIRATION AND RETRIEVAL WERE PERFORMED AGAIN, AND THE THROMBUS WAS SUCCESSFULLY CAPTURED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.