NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE

Description of Event or Problem

DURING A LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM PROCEDURE, THE PHYSICIAN PLANNED TO PERFORM STENT-ASSISTED COIL EMBOLIZATION. AFTER THE ACCESS SYSTEM WAS ESTABLISHED, THE PHYSICIAN SELECTED THE SUBJECT STENT. AFTER REMOVAL AND FLUSH, THE PHYSICIAN DELIVERED THE STENT TO THE TARGET POSITION THROUGH A MICROCATHETER, PARTIALLY DEPLOYED THE STENT AND PACKED COILS FOR EMBOLIZATION, THEN FULLY DEPLOYED THE STENT. AT THAT POINT, THE PHYSICIAN FOUND THAT THE STENT COULD NOT COVER THE COILS AT THE ANEURYSM NECK, AND THE COILS MIGRATED TO THE ANEURYSM OUTSIDE. THE PHYSICIAN SUSPECTED THAT THE STENT HAD NOT FULLY OPENED AND APPOSED TO THE WALL AT THE ANEURYSM NECK, SO ANOTHER STENT WAS DEPLOYED IN SITU TO ACHIEVE NECK COVERAGE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.