Sorin Group Italia has identified a potential problem associated with some of its heart valve products, namely the Perceval S Aortic and Percarbon More Mitral prosthetic heart valves. As a result of the dangers posed to patients by this problem, Sorin Group Italia has voluntarily recalled all of the affected products.
The company issued an urgent field safety notice on 11 August 2014 after it identified the presence of Corynebacterium spp. bacteria on some of the valves they manufacture for use in heart surgery. All of the valves released have been sterilised using a recognised process but Corynebacterium was not included in the validation study and therefore Sorin Group Italia has assessed that there is a risk that the finished product is contaminated.
If a contaminated valve is implanted there is a potential risk that patients may develop infectious endocarditis, which can seriously damage heart valves and cause other serious complications including death. The first line of treatment is intravenous antibiotics but often surgery to replace or repair damaged valves is also often needed.
Sorin Group Italia has published the serial numbers of the products affected on the Medicines and Healthcare Products Regulatory Agency (MHRA) website. The company has asked hospitals and medical professionals to return all unused valves. For those patients who have had one of the effected valves implanted, their doctors will be in contact to inform them of the problem and discuss what action is necessary. Doctors have been urged to closely monitor patients and undertake tests to rule out the presence of endocarditis.
Elise Bevan, a solicitor specialising in product liability claims at Penningtons Manches LLP, said: “This problem appears to have arisen due to a failure in the company’s testing procedures and an investigation will be required to establish how the contamination occurred. Patient safety is paramount and the company will need to consider the effectiveness of their quality control process, with a view to preventing this from happening again. For patients who are potentially affected, it is vitally important that you report any symptoms that you think may be due to infective endocarditis promptly to your doctor. The earlier the condition is diagnosed and treated, the better the likely outcome.
“At Penningtons Manches we can advise you if you believe that you have suffered an injury or fallen ill because of a faulty or defective product. As experts in product liability compensation claims, we will assess the situation, advise you as to what steps you can take and pursue a claim against the appropriate defendant. This is a very specialist area and the right expertise in these types of claim is key.”