ALBOGRAFT POLYESTER VASCULAR GRAFT

Additional Manufacturer Narrative

WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE HAS BEEN IMPLANTED IN THE PATIENT. THE PHYSICAL INCUBATION TEST (WHICH MEASURES HOW WELL THE COLLAGEN WAS CROSSLINKED INTO THE GRAFT), BLOOD AND WATER PERMEABILITY PREVIOUSLY PERFORMED ON A DIFFERENT PORTION OF THE GRAFT FROM THE SAME LOT NUMBER WAS FOUND TO BE ACCEPTABLE. WE HAVE CONDUCTED A LOT HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. WE HAVE SOLD ALL OF THE GRAFTS THAT WERE MANUFACTURED UNDER THIS LOT NUMBER. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. THE PATIENT IS STABLE AND HAS BEEN DISCHARGED FROM HOSPITAL WITH NO POST-OPERATIVE COMPLICATIONS SO FAR. PHYSICIAN STATED HE WAS NOT CONCERNED DURING THIS CASE BUT WANTED TO MAKE US AWARE OF THIS INCIDENT ANYWAYS. SOME AMOUNT OF BLOOD IS EXPECTED TO OOZE OUT FROM THE GRAFT AFTER IMPLANTATION. THE HEMOSTASIS IS EXPECTED TO BE MAINTAINED SPONTANEOUSLY WITHOUT ANY NEED FOR INTERVENTION. THE TIME ADDED ON TO THIS CASE AS A RESULT OF THIS INCIDENT EQUATED TO ABOUT 10 MINUTES. AT THIS TIME, WE CANNOT DETERMINE IF THE GRAFT FAILED OR CONTRIBUTED TO THIS INCIDENT SINCE SOME AMOUNT OF OOZING IS EXPECTED AFTER IMPLANTATION OF THE GRAFT.

Description of Event or Problem

BLOOD WAS OOZING FROM LEFT LIMB OF THE GRAFT NEAR THE SITE OF BIFURCATION ONCE THE SUPPORTING CLAMP WAS REMOVED.