ADVANTA

Additional Manufacturer Narrative

DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 INITIAL REPORTER IS (B)(6). UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED BY HOSPITAL THAT AFTER THE ANASTOMOSIS, ABOUT 5 CM FROM THE BACK OF THE GRAFT, A WHITISH YELLOWISH FLUID STARED TO EXUDE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION SECTION: D9, H6. THE CUSTOMER REPORTED THAT DURING THE USE OF AN ADVANTA VXT GRAFT, ONCE THE ANASTOMOSIS WAS MADE, 5 CM FROM THE BACK OF THE GRAFT, AN EXUDATION OF A WHITISH SUBSTANCE, A TYPE OF YELLOWISH LIQUID BEGAN. THE PATIENT'S RIGHT INGUINAL REGION SHOWS SIGNS OF EDEMA, LIKELY DUE TO INFILTRATION OF THIS TRANSUDATE. BASED ON THE DETAILS OF THIS COMPLAINT IT APPEARS AS IF THE PATIENT IS HAVING A REACTION TO SOMETHING USED WITHIN THE PROCEDURE. THE CLAIM OF A WHITISH OR YELLOWISH FLUID MAY BE DUE TO A FOREIGN BODY RESPONSE HOWEVER THERE ARE NO FLUIDS USED DURING THE PROCESS OF MANUFACTURING. WHEN THE PRODUCT IS PACKAGED IT IS INSPECTED PRIOR TO BEING PLACED IN THE FINAL PACKAGING TRAY. FLUID AT THIS POINT IN THE MANUFACTURING WOULD HAVE BEEN IDENTIFIED. IT IS IMPORTANT TO NOTE THAT ALL GRAFTS ARE PROVIDED STERILE AND PTFE IS AN INERT MATERIAL. IN THIS REGARD IT IS NOT LIKELY THAT THE GRAFT WAS THE CAUSE OF THE EXUDATION OF A WHITISH SUBSTANCE, A TYPE OF YELLOWISH LIQUID AS DESCRIBED IN THE COMPLAINT DETAILS. THE GRAFT USED IN THE PROCEDURE WAS AN ADVANTA VXT THAT HAS A FULL HELIX WINDING. BASED ON THE DESCRIPTION OF THE COMPLAINT IT IS POSSIBLE THAT WHEN THE ANASTOMOSIS WAS CUT A PORTION OF THE HELIX WINDING WAS REMOVED FROM THE GRAFT AND THE OUTER LAYER OF THE GRAFT WAS REMOVED DURING THE PROCESS OF REMOVING THE HELIX. IF THIS WERE THE CASE IT IS POSSIBLE THAT FLUID WAS WEEPING THROUGH THE BASE LAYER OF THE GRAFT. WITHOUT MORE DETAIL OR THE DEVICE IN QUESTION IT IS IMPOSSIBLE TO DETERMINE THE CAUSE OF THE COMPLAINT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE DETAILED INFORMATION AND TO HAVE THE PRODUCT RETURNED AND PICTURES IF POSSIBLE. NO RESPONSE TO REQUESTS WERE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT THERE WERE NO NON-CONFORMANCES NOTED AND THE PRODUCT MET ALL QUALITY AND PERFORMANCE REQUIREMENTS. THERE IS NO INDICATION THAT A DESIGN, MANUFACTURING SPECIFICATION, TEST METHOD, MANUFACTURING PROCESS, EQUIPMENT OR RAW MATERIAL WAS THE CAUSE OF THE COMPLAINT. A RECURRING LOT NUMBER QUERY WAS CONDUCTED FOR L/N 497141 AND THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THE PRODUCTION LOT OF FINISHED GOODS. A HISTORICAL REVIEW OF CAPA AND NCRS WAS COMPLETED, WHICH DID NOT IDENTIFY ANY ISSUES DIRECTLY RELATED TO THIS COMPLAINT. A COMPLAINT HISTORY REVIEW DID IDENTIFY TWO COMPLAINTS WITH SIMILAR DETAILS WHICH NEITHER WERE CONFIRMED TO BE RELATED TO THIS REPORTED COMPLAINT. A RISK REVIEW FOUND THAT THE RISK MANAGEMENT DOCUMENTS FOR THIS PRODUCT ADEQUATELY ADDRESS THE REPORTED DEFECT AND THE SEVERITY AND ANTICIPATED OCCURRENCE LEVEL ARE APPROPRIATE. BASED ON THE LACK OF DETAILS, IMAGES OR RESPONSES FROM THE COMPLAINANT THE ROOT CAUSE IS IMPOSSIBLE TO DEFINE. THE MOST PROBABLE CAUSE IS LIKELY THAT WHEN THE HELIX WAS REMOVED, TOO MUCH MATERIAL WAS REMOVED GOING BACK UP TO 5CM FROM THE ANASTOMOSIS CAUSING THE GRAFT TO WEEP.

Description of Event or Problem

N/A.