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 THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.8X19 MM GRAFTMASTER COVERED STENT WAS ADVANCED WITH A GUIDE EXTENSION CATHETER AND ATTEMPTED MANY TIMES; HOWEVER, THE DEVICE COULD NOT ADVANCE THROUGH THE Y VALVE. AFTER WITHDRAWAL OF THE DEVICE IT WAS FOUND THAT THE SURFACE OF THE COVERED STENT WAS NOT SMOOTH, THERE WAS A FLARED STRUT. A BALLOON WAS USED AS WELL AS A DRUG COATED STENT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

A VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL DEFORMATION AND DIFFICULT TO ADVANCE WERE NOT CONFIRMED. 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, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. FACTORS THAT COULD CONTRIBUTE TO MATERIAL DEFORMATION INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE DURING MANUFACTURING, INADVERTENT MISHANDLING DURING SHEATH/STYLET REMOVAL, PREPARATION, DURING USE OF THE DEVICE, OR INTERACTION WITH ACCESSORY DEVICES. DIFFICULT TO ADVANCE/POSITION MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT ARE NOT LIMITED TO, PRODUCT PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, PATIENT MORPHOLOGY, CONDITION OF THE GUIDE WIRE, INTERACTION WITH ACCESSORY DEVICES, DAMAGE TO THE CATHETER OR ACCUMULATION OF BLOOD OR CONTRAST. IN THIS CASE, IT IS POSSIBLE THE DEVICE MAY HAVE INTERACTED WITH ACCESSORY DEVICES (Y-CONNECTOR/ROTATING HEMOSTATIC VALVE) DURING INSERTION, CAUSING THE REPORTED MATERIAL DEFORMATION (STENT DAMAGE), CONTRIBUTING TO THE REPORTED DIFFICULT TO ADVANCE/POSITION; HOWEVER, BASED ON THE INFORMATION PROVIDED AND ANALYSIS OF THE RETURNED DEVICE, THIS CANNOT BE CONFIRMED. 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.