GRAFTMASTER

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.5X19 MM GRAFTMASTER COVERED STENT FAILED TO CROSS THE LESION. A 2.8X19 MM GRAFTMASTER COVERED STENT FAILED TO CROSS AND A 2.8X16 MM GRAFTMASTER COVERED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE EVALUATED AS THE EXACT ANATOMICAL CONDITIONS ENCOUNTERED BY THE DEVICE USED DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST LABORATORY. BASED ON THE INFORMATION RECEIVED AND ANALYSIS OF THE RETURNED DEVICE, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT, AS IT IS LIKELY THE DEVICE INTERACTED WITH THE MILDLY CALCIFIED, MILDLY TORTUOUS LESION DURING ADVANCEMENT, RESULTING IN THE REPORTED FAILURE TO ADVANCE AND THE OBSERVED DEFORMATION DUE TO COMPRESSIVE STRESS (KINKED HYPOTUBE). FURTHER INTERACTION WITH THE CHALLENGING ANATOMY DURING RETRACTION OF THE DEVICE LIKELY CONTRIBUTED TO THE OBSERVED MATERIAL DEFORMATION (PROXIMAL BENT STENT STRUT). 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.