MalfunctionMAF
CORONARY STENT
Received Jul 25, 2025
Report MW5173350 · MDR key 22613307
Product problems
- Failure to Advance
- Material Deformation
Patient
NA · Unknown
- Stenosis
- Stenosis
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER RADIAL ARTERY ANGIOGRAPHY, IT WAS FOUND THAT THERE WERE 80% STENOS IS AT THE DISTAL END OF THE LCX. 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).