NEUROFORM ATLAS 4.5MM X 15MM NO TIP - CE

Description of Event or Problem

IT WAS REPORTED THAT DURING PCOMA ANEURYSM COIL EMBOLIZATION PROCEDURE, WHEN THE SUBJECT STENT WAS ADVANCING THROUGH THE MICROCATHETER, THE SUBJECT STENT GOT STUCK IN THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN WITHDREW THE SUBJECT STENT TOGETHER WITH THE MICROCATHETER OUT OF THE BODY, SWITCHED TO A DIFFERENT BRAND OF MICROCATHETER AND STENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE, DURING INSPECTION ON THE TABLE, WHEN RETRACTING THE DELIVERY WIRE, IT WAS FOUND THAT THE SUBJECT STENT HAD DEPLOYED WITHIN THE MICROCATHETER. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.