GRAFTMASTER

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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, 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN ANEURYSM IN A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 4.50X26 GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO ANATOMY. A NEW 4.80X19 GRAFTMASTER COVERED STENT WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.