GRAFTMASTER

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 (LCX) ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.8X19MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, THE GRAFTMASTER WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER GRAFTMASTER STENT WAS USED TO TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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 IS LIKELY THE DEVICE INTERACTED WITH THE DIFFICULT ANATOMY (HEAVILY CALCIFIED AND HEAVILY TORTUOUS) DURING ADVANCEMENT TO THE LESION CAUSING THE REPORTED FAILURE TO ADVANCE. BASED ON THE 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. D4 - LOT # & PRIMARY UDI NUMBER UPDATED.