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 CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 90% STENOSIS. THE 3.5X23 MM XIENCE ALPINE STENT WAS IMPLANTED AND DURING POST-DILATATION A PERFORATION OCCURRED. A 3.5X16 MM GRAFTMASTER COVERED STENT WAS ATTEMPTED BUT COULD NOT CROSS. A 3.5X19 MM GRAFTMASTER COVERED STENT WAS USED TO CROSS, SEAL THE PERFORATION AND COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

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. 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 INFORMATION RECEIVED AND ANALYSIS OF THE RETURNED DEVICE, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE, AS IT IS LIKELY THE DEVICE INTERACTED WITH THE MODERATELY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED LESION DURING ADVANCEMENT, RESULTING IN 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.