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 THAT THE PHYSICIAN INTENDED TO IMPLANT THE GRAFTMASTER RX 2.80 X 19 MM STENT IN THE HEAVILY CALCIFIED, TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY TO TREAT A PERFORATION. DESPITE SEVERAL ATTEMPTS TO CROSS, HE COULD NOT CROSS THE LESION WITH THIS DEVICE DUE TO PATIENT ANATOMY. SO HE REMOVED THE UNDEPLOYED GRAFTMASTER DELIVERY SYSTEM AND USED ANOTHER SAME SIZE GRAFTMASTER STENT TO COMPLETE THE CASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DEFORMATION DUE TO COMPRESSIVE STRESS WAS CONFIRMED. 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 DIFFICULTIES APPEAR TO BE RELATED TO OPERATIONAL CONTEXT, AS IT IS LIKELY THE DEVICE INTERACTED WITH THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION DURING ADVANCEMENT, RESULTING IN THE REPORTED FAILURE TO ADVANCE. IT IS ALSO LIKELY THE REPORTED DEFORMATION DUE TO COMPRESSIVE STRESS (KINKED HYPOTUBE) OCCURRED DUE TO INADVERTENT MISHANDLING FOLLOWING THE PROCEDURE. 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. CORRECTIONS: B1 - ADVERSE EVENT/PRODUCT PROBLEM: UPDATED FROM PRODUCT PROBLEM TO ADVERSE EVENT, PRODUCT PROBLEM. B2 - OUTCOMES ATTRIBUTED TO AE: UPDATED FROM NA TO OTHER SERIOUS. H1 - TYPE OF REPORTABLE EVENT: UPDATED FROM MALFUNCTION TO SERIOUS INJURY.

Description of Event or Problem

SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE GRAFTMASTER WAS NOTED TO BE KINKED AFTER THE FAILURE TO CROSS. THE KINK WAS CAUSED BY THE ATTEMPTS TO CROSS THE CALCIFIED AND TORTUOUS ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.