SURPASS ELITE FDS 4.0MM X 17MM - PMAS

Description of Event or Problem

IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT STENT PREMATURELY DETACHED FROM THE RESHEATH PAD WHILE RECAPTURING DEVICE. THE PHYSICIAN REPORTED RESISTANCE WHILE RESHEATHING AND FELT A POP. THE DELIVERY WIRE WAS MOVING INDEPENDENTLY OF THE STENT INDICATING PREMATURE STENT DEPLOYMENT. THE PHYSICIAN PULLED THE MICROCATHETER (WITH HALF OF THE STENT WITHIN THE MICROCATHETER AND ANOTHER HALF OUTSIDE) INTO THE GUIDE CATHETER AND REMOVED THEM. THE STENT WAS FOUND DEPLOYED IN THE HUB OF THE GUIDE CATHETER. THE PROCEDURE WAS DELAYED BY 60 MINUTES. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT,