SURPASS EVOLVE 5.0MM X 20MM - CE

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2025, PATIENT HAD A RIGHT INTERNAL CAROTID ARTERY-OPHTHALMIC (C6 SEGMENT) SACCULAR ANEURYSM (3X2MM, NECK 3.16MM) WITH NO PARENT ARTERY STENOSIS WHICH WAS TREATED WITH THE SUBJECT FLOW-DIVERTER STENT COMPLETELY COVERED ANEURYSM NECK. DURING PATIENT FOLLOW UP VISITS ON (B)(6) 2026, ANGIOGRAM SHOWED ¿AFTER SUBJECT FLOW-DIVERTER STENT IMPLANTATION FOR ANEURYSM AT THE OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY, STENT RETRACTION OCCURRED AND THE ANEURYSM REMAINED UNHEALED¿. THE DISTAL END OF THE SUBJECT FLOW-DIVERTER STENT HAS MIGRATED TO THE PROXIMAL SIDE OF THE ANEURYSM. RETREATMENT WAS PERFORMED ON (B)(6) 2026 WITH ANOTHER FLOW-DIVERTER STENT AND THE ADVERSE EVENT WAS RESOLVED ON 2-MAY-2026 AND THE PATIENT HAS RECOVERED.