Device is not accessible for testing as it remained implanted in patient.A review of the complaint device history records indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.Specifically, no anomaly was evidenced in the collagen coating records.The review of the water permeability testing records of products coated on the same day as the complaint device indicated values well within product specifications.One retention sample coated on the same day and under the same conditions as the complaint device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).The review of post-marketing historical data indicated that no other similar complaint was reported for the same product family and same lot number.No conclusion can be drawn.However, the conducted investigation and testing performed would tend to indicate that the product was not defective at the time of manufacturing.Please note that, as per the product instructions for use, the use of knitted vascular grafts as a conduit for cannulation is not an approved indication.Indeed, hemagard knitted vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.
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