ALBOGRAFT POLYESTER VASCULAR GRAFT

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. THEREFORE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. PER THE IFU: "DEVICE CANNOT BE EXPOSED TO TEMPERATURES ABOVE 45°C (113°F). EXCESSIVE HEAT WILL SERIOUSLY DAMAGE THE ALBOGRAFT POLYESTER VASCULAR GRAFT AND RENDER IT UNFIT FOR USE. 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. GENTLY REMOVE THE SUPPORT SPIRAL, OTHERWISE THE COLLAGEN FILM WILL BE DAMAGED. THE GRAFTS MUST BE KEPT IN THEIR ORIGINAL PACKAGING UNTIL USED. THEY MUST BE KEPT IN A DUST FREE AND DRY ENVIRONMENT AND AT A TEMPERATURE BETWEEN 0 °C /32°F AND 30 °C/ 86 °F." THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. WE HAVE NOT RECEIVED ANY SIMILAR COMPLAINTS RELATED TO THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE MATERIAL OF THE GRAFT STARTED TO DISINTEGRATE AS THE SUTURE WENT THROUGH IT; FURTHER SUTURING MADE THE GRAFT DISINTEGRATE MORE. ANOTHER GRAFT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. NO INJURY WAS REPORTED TO THE PATIENT.