GRAFTMASTER

Description of Event or Problem

IT WAS REPORTED THAT THIS WAS A PROCEDURE PERFORMED TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. DURING THE PROCEDURE, A PERFORATION OCCURRED DURING USE OF AN UNSPECIFIED DEVICE. THE 4.0X19MM GRAFTMASTER COVERED STENT WAS ADVANCED TO TREAT THE PERFORATION; HOWEVER, THE DEVICE FAILED TO CROSS DUE TO THE PATIENT ANATOMY. BALLOON ANGIOPLASTY WAS USED TO TREAT THE PERFORATION AND COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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.