Coroner raises concerns over preparation of heart valves

06 Nov 2009

On Wednesday 4th November 2009 the Oxford Coroner returned a narrative verdict in two inquests that were heard jointly as they both related to deaths following the failure of Labcor tricomposit porcine heart valves that were inserted at the John Radcliffe Hospital in Oxford.

He found that both deaths were because the "heart valves may not have been prepared in accordance with the manufacturers instructions".

The manufacturer Labcor stated in the instructions of use that the heart valves had to be washed 3 times each for 2 minutes and that the valve also needed to be squeezed prior to insertion to ensure that all of the toxic preservative had been washed off. It emerged at the inquest that while the Labcor valve was in use at the John Radcliffe Hospital between 2006 and August 2008 theatre nurses were not squeezing the valves as required and at times were only washing the valves twice.

Mr Alexander McLaren from the Medicines and Healthcare products Regulatory Authority who carried out an investigation in into the reasons for the failure of the valves, gave evidence at the inquest. He stated that if the valves were not rinsed properly then the remaining preservative was toxic to the body and this may cause necrosis or abscess around the valve.

The John Radcliffe Hospital did not link the failure of the heart valves with a failure to prepare them correctly prior to insertion until August 2008, when a dramatically higher number of patients returning with complications was noted. Problems with the valve have also been reported at the Harefield Hospital in Middlesex where 15% of patients have been affected and have required their valves to be replaced.

The valve was in use at a total of 7 hospitals throughout the UK but so far problems with the valve have only been reported at the John Radcliffe and Harfield Hospital. The Labcor valves stopped being distributed in the UK in September 2008 and all centres are now using an alternative product.

Margaret Poyner from Irwin Mitchell says "It is extremely worrying that this valve was implanted in over 400 people throughout the UK until 2008. There could be many more people who have had to have their valves replaced or have even sadly died as a result of premature failure of the valve because it was not correctly prepared prior to insertion".

Solicitors at Irwin Mitchell have now been instructed to pursue a civil claim on behalf of the family of a patient who died after the Labcor valve he had inserted at the John Radcliffe Hospital in 2006 prematurely failed.

If you believe you or your family may have been affected by this issue and wish to speak to a solicitor please contact us.

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