ALBOGRAFT POLYESTER KNITTED VASCULAR GRAFT

Additional Manufacturer Narrative

THE COMPLAINT DEVICES (PIECES OF THE DEVICE) WAS RETURNED FOR EVALUATION. IT WAS OBSERVED TO BE CONTAMINATED WITH BLOOD AND OTHER FLUIDS FROM THE PROCEDURE. THE DEVICES PASSED VISUAL INSPECTION FOR LOOSE THREADS OR KNITTING ISSUES. THE BLOOD PERMEABILITY TEST OF THE PIECES WAS CONDUCTED. WHILE THE DATA OBTAINED WAS IN-LINE WITH THE COMPLAINT DESCRIPTION, WE CANNOT BE SURE IF THE CONTAMINATION WAS A CONTRIBUTING FACTOR TO THESE RESULTS. A SAMPLE WAS ALSO TESTED FOR DEGREE OF CROSSLINKING AND THE RESULTS WERE WITHIN SPECIFICATION. HOWEVER, WE CANNOT BE SURE IF THE PRESENCE OF BLOOD OR OTHER MATERIALS CONTRIBUTED POSITIVELY OR NEGATIVELY TO THE RESULTS OF THIS TEST. A LOT HISTORY REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING THE MFG PROCESSES. THE REVIEW OF THE LOT HISTORY RECORDS FOR THIS BATCH INDICATE THAT ALL OF THE QUALITY CONTROL TESTS PASSED WITH EXPECTED VALUES. A RETAINED SAMPLE FROM THE SAME BATCH WAS TESTED FOR BLOOD PERMEABILITY AND DEGREE OF CROSSLINKING AND WAS FOUND TO HAVE THE SAME (PASSING) TEST VALUES AS THE ORIGINAL LOT RELEASE DATA. THEREFORE, THE ROOT CAUSE OF THE FAILURE REMAINS INCONCLUSIVE, HOWEVER WE BELIEVE IT WAS AN ISOLATED INCIDENT.

Description of Event or Problem

THE DEVICE (GRAFT) WAS LEAKING DURING THE IMPLANTATION. THE LEAKAGE WAS NOTICED AFTER THE GRAFT WAS TUNNELED INTO BOTH GROINS AND BOTH LOWER ANASTOMOSIS (COMMON FEMORAL ARTERY) WERE PERFORMED. THE SURGEON DESCRIBED BLEEDING/SWEATING THROUGH THE GRAFT EVEN THOUGH THE BLOOD SOURCE COULD NOT CLEARLY BE DETERMINED WHETHER COMING FROM THE GRAFT SURFACE, THE PERIGRAFT SPACE OR FROM THE TUNNEL. THE PHYSICIAN ALSO REPORTED DESPITE A "NORMAL" TEG (THROMBOELASTOGRAM) BEFORE THE OPERATION, THE PT WAS OBSERVED TO HAVE ABNORMAL BLOOD CLOTTING FACTORS DURING THE SURGERY, AS NO CLOT FORMED IN THE MAIN BODY OF THE GRAFT, NO BLOOD CLOT IN THE CELL SAVER. ADDITIONALLY IT WAS NOTICED THAT NEITHER APPLYING SWABS WITH PRESSURE NOR SEALANTS (FLOSEAL AND FIBRILLA) COULD STOP THE BLEEDING. AFTER REVERSAL OF THE HEPARIN (A PROTAMIN) - FIRST PARTIAL THEN FULL - THE BLEEDING STOPPED. THE PT WAS STABLE AFTER THE PROCEDURE. THE GRAFT REMAINS IMPLANTED.