ALBOGRAFT POLYESTER VASCULAR GRAFT

Additional Manufacturer Narrative

WE HAVE NOT RECEIVED THE GRAFT FOR EVALUATION SINCE THE SECTION OF THE GRAFT CONTAINING THE HOLE WAS DISCARDED BY THE SURGEON. THE REMAINING PORTION OF THE GRAFT HAS BEEN IMPLANTED IN THE PATIENT. HOWEVER, WE HAVE OBSERVED THE REPORTED INCIDENT IN THE VIDEO THAT WAS PROVIDED TO US. WE OBSERVED A SMALL HOLE IN THE GRAFT WHEN USER FLUSHED THE GRAFT WITH SALINE. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. DURING THE MANUFACTURING PROCESS, THE EXACT GRAFT WAS INSPECTED BY A QUALITY CONTROL INSPECTOR FOR HOLES, BROKEN THREADS, AND ANY LOOSE FIBERS IN THE GRAFT. NO DEFECT WAS NOTED DURING THE INSPECTION PROCESS. A SAMPLE OF GRAFTS FROM THIS LOT NUMBER WERE ALSO TESTED FOR WATER PERMEABILITY AND PUNCTURE TEST. ALL OF THE SAMPLES MET ITS SPECIFICATION. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FROM THIS LOT. DUE TO THE PRODUCT BEING DISCARDED A ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THIS SECTION OF THE GRAFT CAME IN CONTACT WITH A SHARP OBJECT DURING THE PROCEDURE WHICH COULD HAVE DAMAGED THE GRAFT.

Description of Event or Problem

AN IMPLANT OF ALBOGRAFT AMC3008 FOR BYPASS WAS IN PROCESS. AT THE DISTAL PART OF THE GRAFT, THEY FOUND A SMALL HOLE. THIS PART WAS NOT AIMED TO BE USED, SO IT WAS CUT OFF AND WAS NOT USED. CONCLUSION A SMALL HOLE IN THE GRAFT WAS RECOGNIZED, BUT IT WAS NOT IN CONTACT OR BEEN USED IN THE PATIENT. THE GRAFT WAS DISCARDED BY THE HOSPITAL. THERE WAS NO INJURY REPORTED.