ALBOGRAFT POLYESTER VASCULAR GRAFT

Additional Manufacturer Narrative

WE HAVE NOT RECEIVED THE GRAFT FOR EVALUATION SINCE THE GRAFT WAS IMPLANTED IN THE PATIENT. HOWEVER, WE HAVE OBSERVED THE REPORTED INCIDENT IN THE PICTURES PROVIDED TO US. WE OBSERVED A SMALL HOLE IN THE GRAFT. THE SURGEON DID NOT CHECK FOR HOLES OR OTHER DEFECTS BEFORE IMPLANTATION. 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 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. THEREFORE, WE BELIEVE THAT IT WAS AN ISOLATED INCIDENT. WE HAVE ALSO REVIEWED OUR COMPLAINT HISTORY RECORDS FOR LAST 4 YEARS AND SEARCHED FOR A SIMILAR ISSUE WHERE A HOLE/TEAR WAS FOUND IN AN ALBOGRAFT POLYESTER VASCULAR GRAFT. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS FOR A SIMILAR ISSUE. THE CURRENT RATE OF OCCURRENCE IS WITHIN OUR EXPECTED RATE OF OCCURRENCE. UNFORTUNATELY, OUR ANALYSIS WAS LIMITED TO ONLY THE INFORMATION PROVIDED AND NO PHYSICAL SAMPLE WAS AVAILABLE TO US FOR INVESTIGATION. WE THEREFORE 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 DEVICES. NO CORRECTIVE ACTION IS NEEDED AT THIS TIME. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. SURGEON SEWED THE HOLE AFTER OBSERVING THE HOLE IN THE GRAFT. APPROXIMATELY 150 CC OF BLOOD WAS LOST AND THE OPERATION TIME EXTENDED BY 20 MINUTES. ON MAY 19, 2020, WE WERE INFORMED THAT THE PATIENT IS DOING FINE. THERE WERE NO IMPACT ON THE PATIENT'S HEALTH AS A RESULT OF THE GRAFT MALFUNCTION.

Description of Event or Problem

INTRAOPERATIVELY, A HOLE WAS NOTICED IN THE GRAFT. THE HOLE WAS 3-4MM IN SIZE. ON ONE PICTURE IS A 1.2MM DULL- HEADED CANNULA IN THE HOLE OF THE GRAFT. THE HOLE WAS SEWN OVER. THE PATIENT WAS STILL IN THE OPERATION ROOM, WHEN THEY CALLED US. THERE WAS NO IMPACT ON PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT.