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 THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.5X16MM RX GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED; HOWEVER, THE GRAFTMASTER FAILED TO CROSS DUE TO THE ANATOMY. THE GRAFMASTER WAS REMOVED FROM THE PATIENT. ANOTHER 3.5X16MM GRAFTMASTER STENT WAS ABLE TO CROSS AND WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN 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 HEAVILY CALCIFIED, HEAVILY TORTUOUS 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.