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 THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 3.50 X 26 MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO COVER A PERFORATION HOWEVER FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL INSPECTION WAS 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.

Description of Event or Problem

SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE HYPOTUBE WAS SEPARATED. FOLLOW UP INFORMATION CONFIRMED THE SEPARATION OCCURRED DUE TO HANDLING POST PROCEDURE DURING PACKING FOR RETURN ANALYSIS.