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 OF SPECIFIC ISSUE. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE (IFU), AS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. B2: OUTCOMES ATTRIBUTED TO AE UPDATED. H6: HEALTH EFFECT - IMPACT CODE 4614 REMOVED, CODE 4641 ADDED.

Description of Event or Problem

SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS PROVIDED. THE GRAFTMASTER COVERED STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, IVUS WAS PERFORMED AND THE STENT WAS OCCLUDED. BALLOON INFLATIONS WERE USED AS TREATMENT. THERE WERE NO ADVERSE PATIENT SEQUELA 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.

Description of Event or Problem

IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A PERFORATION OCCURRED THEREFORE A 2.80X19MM GRAFTMASTER COVERED STENT WAS IMPLANTED TO SEAL THE PERFORATION. POST IMPLANT THE STENT OCCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED.