GRAFTMASTER

Additional Manufacturer Narrative

A VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE WAS NOT TESTED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 OBSERVATIONS FROM THE RETURNED ANALYSIS, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THE DEVICE INTERACTED WITH THE CHALLENGING ANATOMY WHICH WAS DESCRIBED AS HEAVILY CALCIFIED AND HEAVILY TORTUOUS RESULTING IN 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.

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 DIAGONAL ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.8X19MM GRAFTMASTER COVERED STENT SYSTEM WAS ATTEMPTED TO ADVANCED TO THE TARGET LESION; HOWEVER, THE GRAFTMASTER 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 SAME SIZE GRAFTMASTER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.