((b)(4)) a review of the device history records, indicated that the graft was processed and inspected according to 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.Please note that water permeability testing is recognized by international standard for vascular grafts as the test to address the risk of blood leakage.((b)(4)) one retention sample coated on the same period and under the same conditions as the involved device underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).((b)(4)) 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.
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Following the receipt of the additional information, the case was reviewed by our corporate medical officer.His clinical opinion is the following: "the use of the intergard woven graft in an axillary position represents an off-label use.It is however a well published method of perfusion for this kind of procedure.The oozing is due, in most cases, to the high flow and shear stress through the graft.In this case, the oozing was self-contained and did not require an intervention or additional blood transfusion.The procedure was carried out without interruption or delay.The patient's post-operative course was uneventful." as per the instructions for use, intergard woven vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the aorta, both thoracic and abdominal, visceral arteries, and proximal peripheral arteries.
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