GRAFTMASTER

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 PREVENTIVE 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 OF SPECIFIC ISSUE. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE, 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 AND OBSERVED DEFORMATION DUE TO COMPRESSIVE STRESS (KINKED HYPOTUBE AND OUTER MEMBER). FURTHER INTERACTION WITH THE CHALLENGING ANATOMY DURING RETRACTION OF THE DEVICE LIKELY CONTRIBUTED TO THE OBSERVED MATERIAL DEFORMATION (PROXIMAL STENT DAMAGE), ULTIMATELY CAUSING THE OBSERVED STENT DISLODGEMENT. THE OBSERVED DEFORMATION DUE TO COMPRESSIVE STRESS (KINKED STYLET) LIKELY OCCURRED DURING UNPACKAGING OF THE DEVICE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

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 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.