GRAFTMASTER

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ELECTRONIC LOT HISTORY RECORD (ELHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT DURING ADVANCEMENT RESISTANCE WAS MET WITH THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS ANATOMY RESULTING IN THE REPORTED FAILURE TO ADVANCE. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT CIRCUMFLEX CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.8X19 MM GRAFTMASTER COVERED STENT COULD NOT CROSS DUE TO THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.