THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE DIFFICULTIES COULD NOT BE DETERMINED. IT MAY BE POSSIBLE THAT THE VESSEL DIAMETER WAS NARROWED IN SOME LOCATIONS CAUSING THE STENTS TO ELONGATE DURING DEPLOYMENT; HOWEVER, THIS COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL SUPERA DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.
D
Patient 1
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POPLITEAL ARTERY AND FEMORAL ARTERY. FOLLOWING PRE-DILATATION, A 6.5X200MM SUPERA SELF-EXPANDING STENT (SES) WAS DEPLOYED IN THE POPLITEAL ARTERY AND 6.5X100MM SUPERA SES WERE DEPLOYED IN THE FEMORAL ARTERY; HOWEVER, THEY SEEMED TO BE LONGER THAN THE SIZE ON THE LABEL. THE 6.5X200MM SES MEASURES AROUND 300MM POST-DEPLOYMENT AND THE 6.5X100MM SES MEASURES AROUND 180MM POST-DEPLOYMENT, BOTH STENTS ELONGATED MORE THAN 10%. BOTH SESS WERE REMOVED UNDER FLUOROSCOPY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO CONSEQUENCE TO THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.