NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ACOMA ANEURYSM STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, AFTER DELIVERING THE FIRST COIL INTO THE ANEURYSM TO FRAME, THE STENT MICROCATHETER WAS DELIVERED INTO POSITION. RESISTANCE NOTED WHILE ADVANCING THE SUBJECT STENT IN THE MICROCATHETER AND IT DEPLOYED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN WITHDREW THE ENTIRE STENT SYSTEM OUT OF THE BODY, CUT OPEN THE MICROCATHETER, AND USED THE DELIVERY WIRE PROXIMAL END TO PUSH INTO THE MICROCATHETER, CONFIRMING THAT THE DEPLOYED STENT WAS LOCATED AT THE PROXIMAL SIDE OF THE CUT MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.