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 PERFORMED TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE A 2.80X26MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE USED TO TREAT A PERFORATION; HOWEVER, THE SDS WAS UNABLE TO CROSS DUE TO THE TORTUOSITY. THEREFORE, THE PERFORATION WAS TREATED WITH ANOTHER RX GRAFTMASTER. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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.