UK MHRA has issued Medical Device Alert(MDA) pertaining to all lots of the AlboGraft Polyester Vascular Graft, manufactured by vascular company, LeMaitre Vascular GmbH. The alert can be found here.
Woven and knitted vascular prostheses have been around for many years for use in repair of the aorta or the peripheral vessels. Uncoated grafts have an open structure, so require pre-clotting with the patient’s own blood. Alternatively, when “coated” grafts are used, these feature a haemostatic component which can be albumin, collagen or gelatin, which require processing by the manufacturer by cross-linking to effectively render them pre-clotted. Selection of a coated graft is usually a question of surgeon preference, although they are indicated for patients with coagulation disorders or requiring of systemic heparinisation. AlboGraft is a coated graft.
According to the MHRA alert, all lots of AlboGraft are at risk of suffering uncontrolled bleeding on implantation. In the first reported incidence, from last October, the manufacturer established that the haemostatic coating, which we’re guessing is albumin based, had been incorrectly cross-linked with the net effect being that the arterial blood did not clot in the polyester wall of the graft. The company issued a field safety notice pertaining to one batch of product.
However, despite company assurances that this was a one-off, it recurred in February from a different batch and has been reported again since. LeMaitre is now trying to establish the root cause of the problem.
Consequently the MHRA has taken the action of issuing a Medical Device Alert, making the recommendation that all grafts should be leak-tested prior to implantation, back-up grafts should be available and any further leakages should be reported to MHRA. No recall has been issued at this time.
In effect, once implanted and no longer bleeding the graft performs like an uncoated product, so should present no risk to the patient, although it seems slightly strange that the company has not recalled nor apparently suspended sales of the product until it has identified a root cause. Without a known cause, all product must be considered at some risk, which raises a questionmark in our minds about the acceptability of allowing continued use of a compromised product. Furthermore there is no mention of the problem on the company’s website.
The AlboGraft was cleared by FDA (510k) in January 2010. At the present time FDA has not issued a warning.