SURPASS EVOLVE 4.0MM X 25MM - CE

Description of Event or Problem

IT WAS REPORTED THAT DURING RIGHT INTERNAL CAROTID ARTERY ICA ANEURYSM FLOW DIVERTER STENT IMPLANTATION PROCEDURE, THE PHYSICIAN DEPLOYED THE SUBJECT STENT FOLLOWING STANDARD PROCEDURE; HOWEVER, WHEN THE STENT WAS PARTIALLY DEPLOYED TO ITS MID-SECTION, THE DELIVERY WIRE FRACTURED APPROXIMATELY 20MM FROM ITS TIP. FOR PROCEDURAL SAFETY, THE PHYSICIAN RETRACTED THE ENTIRE STENT USING THE MICROCATHETER AND WITHDREW IT OUT OF THE BODY. SUBSEQUENTLY, TO REUSE THE MICROCATHETER, THE PHYSICIAN PUSHED THE STENT OUT OF THE MICROCATHETER AND DEPLOYED IT ON THE TABLE. THE MICROCATHETER WAS THEN RE-SUPERSELECTED TO THE DISTAL END OF THE FRACTURED DELIVERY WIRE, AND A RETRIEVER STENT WAS USED TO RETRIEVE THE FRACTURED DISTAL WIRE OUT OF THE BODY. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.