GRAFTMASTER

Description of Event or Problem

IT WAS REPORTED THAT THE 2.8X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY AFTER SEVERAL ATTEMPTS TO TREAT A PERFORATION. ANOTHER GRAFTMASTER COVERED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Additional Manufacturer Narrative

A VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IN THIS CASE, IT IS LIKELY THE DEVICE INTERACTED WITH THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS LESION DURING ADVANCEMENT CAUSING THE REPORTED FAILURE TO ADVANCE. DURING REMOVAL AND/OR AFTER REMOVAL OF THE DEVICE THE REPORTED SEPARATION OCCURRED LIKELY DUE TO HANDLING AND/OR MANIPULATION OF THE DEVICE. 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. B5: DESCRIBE EVENT OR PROBLEM: UPDATED.

Description of Event or Problem

SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: A SEPARATION OF THE DELIVERY CATHETER HYPOTUBE OCCURRED OUTSIDE THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.