SURPASS EVOLVE 4.5MM X 30MM - CE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD LEFT PCOMA (POSTERIOR COMMUNICATING ARTERY) SEGMENT STENOSIS COMBINED WITH AN ANEURYSM, THE PHYSICIAN PREPARED TO DEPLOY THE SUBJECT STENT. THE PHYSICIAN NORMALLY RETRIEVED THE SUBJECT STENT AND FLUSHED IT, THEN DELIVERED IT THROUGH THE MICROCATHETER TO THE TARGET POSITION FOR DEPLOYMENT. THE DISTAL END OF THE SUBJECT STENT OPENED SMOOTHLY AND APPOSED TO THE WALL, BUT AFTER APPROXIMATELY ONE-THIRD OF THE SUBJECT STENT HAD BEEN DEPLOYED, THE SUBJECT STENT COULD NOT OPEN SMOOTHLY AT THE PCOMA SEGMENT AND FAILED TO APPOSE TO THE WALL. THE PHYSICIAN RETRIEVED AND REDEPLOYED THE SUBJECT STENT, AND AFTER THREE ATTEMPTS STILL COULD NOT OPEN. THE PHYSICIAN THEN CONTINUED TO ATTEMPT DEPLOYING IT USING A PUSH-AND-SQUEEZE METHOD, BUT WAS STILL UNABLE TO EXPAND THE SUBJECT STENT OPEN. ULTIMATELY, THE PHYSICIAN HAD TO RETRIEVE AND WITHDRAW THE SUBJECT STENT. WHEN THE PHYSICIAN WITHDREW THE SUBJECT STENT DELIVERY WIRE, THE SUBJECT STENT DEPLOYED INSIDE THE MICROCATHETER. THE PHYSICIAN WITHDREW THE MICROCATHETER, CHANGED STRATEGY, AND CHOSE STENT-ASSISTED COIL EMBOLIZATION. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.