CORONARY STENT

Description of Event or Problem

IT WAS REPORTED THAT AFTER RADIAL ARTERY ANGIOGRAPHY OF THE PATIENT, IT WAS FOUND THAT THE PROXIMAL OF LAD HAD 80% STENOS IS, AND THE OPTICROSS HD CATHETER WAS KINKED, AND A NON (B)(6) STENT COULD NOT CROSS THE CATHETER. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED NORMALLY. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).