ALBOGRAFT POLYESTER VASCULAR GRAFT

Description of Event or Problem

IT WAS REPORTED THAT THE ALBOGRAFT WALL WAS LEAKING AFTER BEING CLOSED WITH SUTURES FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. LEAKAGE OCCURRED FROM THE GRAFT RESULTING IN LONGER OPERATION TIME AND BLOOD LOSS. AN ALTERNATE GRAFT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATION OR INJURY WAS REPORTED TO THE PATIENT.

Additional Manufacturer Narrative

THE PRODUCT WAS DISCARDED AT THE SITE AND THEREFORE NOT AVAILABLE FOR EVALUATION. AS A RESULT, THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONFIRMED. IT IS POSSIBLE THAT HANDLING OF THE DEVICE AND PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED ISSUE. DURING MANUFACTURING, ALL DEVICES ARE POROSITY TESTED TO ENSURE THE PRODUCT CONFORMS TO SPECIFICATIONS AND DOES NOT LEAK DURING TESTING. AS NOTED IN THE IFU: FOR SUTURING, CYLINDRICAL NEEDLES ARE RECOMMENDED; ALTHOUGH TAPER CUT OR OTHER CUTTING NEEDLES ARE NOT CONTRAINDICATED. AVOID OVERSTRETCHING THE GRAFT; GENTLY EXPAND THE GRAFT TO SMOOTH THE FOLDS. AVOID DAMAGING THE GRAFT WHEN HANDLING, USE ATRAUMATIC CLAMPS AND APPROPRIATE INSTRUMENTS (E.G. VASCULAR CLAMPS). AVOID USING THESE INSTRUMENTS WITH UNDUE FORCE, OTHERWISE THE COLLAGEN COATING OR FABRIC WILL BE DAMAGED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY ISSUES THAT WOULD CAUSE THE REPORTED ISSUE.