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 DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY A GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED TO TREAT A PERFORATION; HOWEVER, THE GRAFTMASTER FAILED TO CROSS. A GUIDE EXTENSION CATHETER WAS USED AND AN INJECTION WAS ADMINISTERED TO MANAGE THE PERFORATION; HOWEVER, THE INJECTION THAT WAS ADMINISTERED LED TO SLOW FLOW AND NO RE-FLOW AND THE PATIENT WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED; HOWEVER, AFTER SEVERAL HOURS THE PATIENT EXPIRED. PER THE PHYSICIAN, THE FAILURE TO CROSS OF THE GRAFTMASTER STENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT ADVERSE EFFECTS OR DEATH. 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. IT WAS REPORTED THAT THE GRAFTMASTER COVERED STENT WAS ATTEMPTED TO BE ADVANCED TO THE PERFORATION: HOWEVER, THE GRAFTMASTER FAILED TO CROSS. IT IS LIKELY THAT THE INTERACTION WITH THE HEAVILY CALCIFIED AND TORTUOUS LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THE REPORTED DEATH WAS CONFIRMED NOT TO BE RELATED TO THE GRAFTMASTER OR THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. CORRECTION: D9 - DEVICE AVAILABLE FOR EVALUATION - UPDATED TO NO.