ALBOGRAFT POLYESTER KNITTED VASCULAR GRAFT

Additional Manufacturer Narrative

THE COMPLAINT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION SINCE IT REMAINS IMPLANTED. A LOT HISTORY REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING THE MANUFACTURING 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, AND WE WERE NOT ABLE TO RECREATE A FAILURE. THEREFORE, THE ROOT CAUSE OF THE FAILURE REMAINS INCONCLUSIVE. BASED ON THE COMPLAINT DESCRIPTION, IT IS POSSIBLE THE DEVICE WAS DAMAGED BY THE USER DURING THE CLAMPING. WE WERE NOT ABLE TO RECEIVE FROM THE USER USED CLAMPS DESCRIPTION DUE TO NON-RESPONSIVENESS. HOWEVER, WE BELIEVE IT WAS AN ISOLATED INCIDENT. PLEASE NOT THAT NO PERMANENT INJURY TO THE PATIENT HAPPENED DUE TO THIS INCIDENT.

Description of Event or Problem

THE DEVICE (GRAFT) WAS LEAKING DURING THE IMPLANTATION. PRODUCT WAS LEAKING BLOOD WHERE THE CLAMPS WERE PLACED ONCE TAKEN OFF: THE SURGEON SEWED IN THE GRAFT AND UPON COMPLETION, RELEASED THE CLAMPS AND COULD NOT CONTROL THE BLOOD LOSS FROM THE CLAMPING AREA FOR ABOUT 25 MIN. THE GRAFT REMAINS IMPLANTED. THE PATIENT LOSS ADDITIONAL BLOOD DURING THE PROCEDURE DUE THE INCIDENT, BUT WAS STABLE AFTER THE PROCEDURE. NO PERMANENT INJURY HAPPENED.