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. AT THIS TIME, WE REMAIN INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE ISSUE, BUT BASED ON THE DOCUMENTATION AND COMPLAINT HISTORY REVIEW, WE DO NOT BELIEVE THERE IS A SYSTEMIC ISSUE WITH THESE GRAFTS. 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. SINCE JANUARY 2018- NOW, WE HAVE RECEIVED A TOTAL OF 2 COMPLAINTS WHERE THE SURGEON OBSERVED A HOLE IN THE GRAFT. THE CURRENT RATE OF OCCURRENCE OF 0.007% FOR THIS FAILURE MODE IS WITHIN OUR EXPECTED RATE OF OCCURRENCE OF 0.01%. NONE OF THE TWO REPORTED CASES CAUSED ANY HARM TO THE PATIENT.

Description of Event or Problem

DURING PROCEDURE, AFTER COMPLETING DISTAL ANASTOMOSIS, SURGEON OBSERVED A SMALL HOLE IN ONE OF THE BIFURCATED LEG WHEN FLUSHING IT WITH SALINE. THE SECTION OF THE GRAFT WITH THE HOLE WAS DISCARDED. THERE WAS NO HARM TO THE PATIENT AS THE RESULT OF THIS INCIDENT.