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 ISSUE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. 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 TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 2.8X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO ANATOMY. ANOTHER GRAFTMASTER WAS USED TO SUCCESSFULLY SEAL THE PERFORATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.