NEUROFORM 3 EZ 3.0MM X 20MM - CE

Description of Event or Problem

IT WAS REPORTED THAT DURING A MIDDLE CEREBRAL ARTERY STENOSIS PROCEDURE THE PHYSICIAN PLANNED TO PERFORM INTRACRANIAL BALLOON DILATION FOLLOWED BY STENT IMPLANTATION. THE SUBJECT STENT WAS SELECTED FOR IMPLANTATION. AFTER THE STENT WAS DELIVERED TO THE TARGET POSITION, THE PHYSICIAN DEPLOYED THE STENT, BUT THE STENT DID NOT FULLY OPEN AFTER DEPLOYMENT. THE PHYSICIAN ATTEMPTED TO MASSAGE IT WITH THE GUIDEWIRE, BUT THE SUBJECT STENT STILL DID NOT OPEN AND HAD SHIFTED, AND THROMBUS WAS GENERATED. THE PHYSICIAN ULTIMATELY USED A RETRIEVER STENT TO RETRIEVE THE THROMBUS AND SUBJECT STENT OUT TOGETHER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.