GRAFTMASTER

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. PRODUCTION RECORD AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO ADVANCE COULD NOT BE DETERMINED; HOWEVER, FACTORS THAT COULD CONTRIBUTE TO FAILURE TO ADVANCE INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, INTERACTION WITH PREVIOUSLY PLACED STENTS OR ACCESSORY DEVICES. IN THIS CASE, IT IS POSSIBLE THE DEVICE MAY HAVE INTERACTED WITH THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION DURING ADVANCEMENT, RESULTING IN THE REPORTED FAILURE TO ADVANCE; HOWEVER, WITHOUT THE DEVICE TO EXAMINE, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE REPORT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT PERFORATION OF A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.8X19MM GRAFTMASTER COVERED STENT FAILED TO CROSS DUE TO THE ANATOMY AND THERE WERE NO OTHER ISSUES NOTED. ANOTHER 2.8X19MM GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE USED BUT STILL FAILED TO CROSS DUE TO THE ANATOMY. THERE WERE NO OTHER ISSUES NOTED. THE PROCEDURE WAS THEN COMPLETED AT THIS POINT WITHOUT USE OF ANOTHER GRAFTMASTER. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.