ALBOGRAFT POLYESTER VASCULAR GRAFT

Additional Manufacturer Narrative

WE HAVE RECEIVED THE GRAFT FOR EVALUATION. WHEN THE GRAFT WAS OBSERVED VISUALLY, WE DID NOT FIND ANY HOLES OR EXTERNAL DEFECTS IN THE GRAFT THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE PHYSICAL INCUBATION TEST (WHICH MEASURES HOW WELL THE COLLAGEN WAS IMPREGNATED INTO THE GRAFT) PREVIOUSLY PERFORMED ON A PORTION OF THIS EXACT COMPLAINT DEVICE WAS FOUND TO BE ACCEPTABLE. AN UNUSED GRAFT FROM THE SAME LOT NUMBER WAS TESTED FOR WATER PERMEABILITY DURING THIS INVESTIGATION. THE GRAFT PASSED THIS TEST. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES AT THE FINISHED GOOD, SUB ASSEMBLY OR RAW MATERIAL PHASE OF PRODUCTION THAT COULD BE RELATED TO THIS INCIDENT. OUR LOT DISTRIBUTION RECORDS SHOW THAT (B)(4) UNITS FROM THIS LOT HAVE BEEN SOLD. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS FROM CUSTOMERS RELATED TO A SIMILAR ISSUE. WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT AND CONSIDER IT AN ISOLATED INCIDENT. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

Description of Event or Problem

ALBOGRAFT VASCULAR GRAFT AMC2010 LOT# 140129 SERIAL NUMBER (B)(4) WAS USED DURING OPEN AORTA ANEURISM TREATMENT. AFTER PERFORMING PROXIMAL ANASTOMOSIS, THE GRAFT START TO BLEED WHEN THE CLAMP WAS REMOVED. SO, ANOTHER LEMAITRE ALBOGRAFT WAS USED TO COMPLETE THE PROCEDURE.