GRAFTMASTER

Additional Manufacturer Narrative

A VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE TESTED AS IT WAS BASED ON OPERATIONAL CONTEXT. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IT WAS REPORTED THAT THE CORONARY STENT GRAFT SYSTEM (CSGS) FAILED TO CROSS THE LESION. IT IS LIKELY THAT THE INTERACTION WITH THE ANATOMY RESULTED IN THE REPORTED FAILURE TO ADVANCE. THE ANALYSIS OF THE RETURNED DEVICE CONFIRMED THE CROSSING PROFILE MET SPECIFICATION. IN ADDITION, THE ANALYSIS NOTED BENDS ON THE HYPOTUBE. IT IS LIKELY THAT THE MANIPULATION OF THE DEVICE, WHEN RESISTANCE WAS MET, CONTRIBUTED TO THE NOTED BENDS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT CIRCUMFLEX CORONARY ARTERY WITH 85% STENOSIS. THE PERFORATION OCCURRED DURING RE-ADVANCEMENT OF A GUIDE WIRE AFTER AN UNSPECIFIED STENT WAS IMPLANTED. THE 2.8X16 MM GRAFTMASTER COVERED STENT FAILED TO CROSS THE LESION DESPITE REPEATED ATTEMPTS. BALLOON DILATATION WAS USED TO TREAT THE PERFORATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.