ALBOGRAFT POLYESTER KNITTED VASCULAR GRAFT

Description of Event or Problem

THE ALBOGRAFT POLYESTER VASCULAR GRAFT (AMC1608 - 16 X 8 MM) WAS USED FOR A INFRARENAL AORTIC ANEURYSM REPAIR PROCEDURE. THE GRAFT WAS IMPLANTED. WHEN THE PROXIMAL CLAMP WAS REMOVED THE SURGEON NOTED THAT IT LOOKED LIKE EITHER THE BLOOD WAS LEAKING THRU GRAFT'S WALLS SINCE THE GRAFT WAS FILLED WITH BLOOD OR THE BLOOD WAS COMING FROM AN UNK SOURCE. THE PT WAS UNDER INTRAOPERATIVE HEPARINIZATION. THE SURGEON CLAMPED THE GRAFT AND THE ASSISTANT SURGEON USED COMPRESSIONS AND HEMOSTATIC AGENT WHILE THE SURGEON CONTINUED THE PROCEDURE AS PLANNED WITH AN ADD'L ELECTIVE FEMORO-POPLITEAL BYPASS IN THE SAME SESSION WITH THE SAME PT. THE HEPARINIZATION HAD NOT BEEN REVERSED WITH PROTAMIN. THE USE OF COMPRESSIONS AND HEMOSTATIC AGENT WAS SUCCESSFUL, AND THE SURGEON DID NOT SEE ANY REASON TO REMOVE/EXPLANT THE GRAFT, SO THE GRAFT REMAINED IMPLANTED. THE ADD'L TIME THAT WAS REQUIRED WAS INSIGNIFICANT AS THE ADD'L PROCEDURE (FEM-POP BYPASS) WAS SUCCESSFULLY COMPLETED CONCURRENTLY. BOTH PROCEDURES (AAA-REPAIR AND FEM-POP BYPASS) WERE COMPLETED IN STANDARD FASHION W/O ANY ADD'L MEASURES. NO PICTURES OR VIDEOS WERE TAKEN DURING THE PROCEDURE. NO PT INJURY HAPPENED.

Additional Manufacturer Narrative

SMALL CUT-OFF PORTIONS OF THE COMPLAINT DEVICE (4CM MAIN BODY, 10CM (X2) LEGS) WERE RETURNED FOR EVAL ON (B)(4) 2013. THE RETURNED PIECES OF GRAFT WERE SIGNIFICANTLY COVERED WITH CLOTTED BLOOD. INITIAL VISUAL INSPECTION DID NOT REVEAL ANY TEXTILE DEFECTS. THE PIECES WERE DECONTAMINATED FOR 24 HRS BY SUBMERGE IN CYDEX DISINFECTION SOLUTION. FOLLOWING THIS, BLOOD TESTING OF THE DECONTAMINATED COMPLAINT GRAFT PIECES YIELDED A FAILING RESULT - SOMEWHAT CONSISTENT WITH THE REPORTED COMPLAINT, BUT VERY LIKELY AGGRAVATED BY THE DECONTAMINATION PROCESS AND/OR CLOTTED BLOOD THAT WAS REMOVED AND THEREFORE THIS TEST MAY BE MISLEADING. A LOT HISTORY REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING THE MFG PROCESSES. THE COMPLAINT LOT AND THE COLLAGEN BATCH PASSED ALL REQUIRED TEST (TOTAL 5 (9%) GRAFTS WERE TESTED BEFORE LOT WAS RELEASED FROM THE COMPLAINT BATCH FOR BLOOD AND WATER PERMEABILITY). IN ORDER TO VERIFY A POSSIBLE COLLAGEN IMPREGNATION CROSS-LINKING PROBLEM WE TESTED THREE ADD'L GRAFTS FROM THE SAME LOT (58819) AND COLLAGEN CROSSLINKING BATCH A. ALL THREE GRAFTS PASSED THE BLOOD PERMEABILITY TEST BRINGING THE TOTAL BATCH TESTING TO 8 (15%). WE ADDITIONALLY CONFIRMED THE SUCCESSFUL IMPLANTATION OF 6 GRAFTS FROM THE SAME COLLAGEN CROSSLINKING BATCH A WITH NO ISSUES. THEREFORE, THE ROOT CAUSE OF THE FAILURE REMAINS INCONCLUSIVE. HOWEVER, IT IS AN ISOLATED INCIDENT SINCE WE WERE NOT ABLE TO IDENTIFY ANY ISSUES WITH OTHER GRAFTS FROM THE SAME LOT (INCLUDING THE SAME TEXTILE AND CROSSLINKING BATCH).