GRAFTMASTER

Additional Manufacturer Narrative

A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A VISUAL, FUNCTIONAL, 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 HEAVILY CALCIFIED, HEAVILY TORTUOUS, 99% 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT WAS 99% STENOSED WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.8X19MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE GRAFTMASTER FAILED TO CROSS DUE TO THE ANATOMY. THEN, A 3.5X19MM GRAFTMASTER WAS ATTEMPTED TO BE ADVANCE, HOWEVER, THE SECOND GRAFTMASTER ALSO FAILED TO CROSS DUE TO THE ANATOMY. ANOTHER GRAFTMASTER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY THAT WAS 99% STENOSED WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.8X19MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE GRAFTMASTER FAILED TO CROSS DUE TO THE ANATOMY. THEN, A 3.5X19MM GRAFTMASTER WAS ATTEMPTED TO BE ADVANCE, HOWEVER, THE SECOND GRAFTMASTER ALSO FAILED TO CROSS DUE TO THE ANATOMY. ANOTHER GRAFTMASTER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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.