On 9 April 2015 commenced an investigation into the death of Sheila Mary Hynes, aged 72 years whose death was confirmed on the 2 April 2015 within the Freeman Hospital, Newcastle upon Tyne. The investigation concluded at the end of the inquest; which was heard between the 19 and 21 June 2017 inclusive_ The conclusion of the inquest was a Narrative: Sheila Hynes died due to an aortic and mitral valve replacement procedure during which sutures securing the mechanical aortic valve snapped: The valve was explanted, remounted on it's holder (contrary to manufacturers instructions) in an inverted position, leading to reimplantation of that valve in an inverted position Opportunities were missed to identify and rectify the position of the valve causing Mrs Hynes acute heart damage from which she could not recover:

Sheila Mary Hynes suffered from rheumatic aortic and mitral valve disease and had previously undergone mitral valvuloplasty As a consequence of disease progression, Mrs Hynes underwent an Aortic and Mitral Valve Replacement procedure on the 26 March 2015 within the Freeman Hospital in Newcastle_ Mechanical valves were considered the most appropriate given Mrs Hynes clinical history. The primary surgeon selected a Sorin Carbomedics 23 mm mechanical by-leaflet prosthetic heart valve to replace Mrs Hynes native aortic valve_ said valve was supplied on a holder: The manufacturer's instructions for use clearly state that the valve should not be remounted on the holder: valve holder was not a unidirectional holder: It was therefore possible for the valve, if remounted; to be remounted in an inverted position: This fact was not known by the primary surgeon or any member of the operating team: During the_replacement of Mrs Hynes aortic valve_a suture snapped,necessitating the_ Lord Mayor'$ Gallery, Civic Centre, Barras Bridge; Newcastle Upon Tyne, NEL 8QA Tel 0191 2777280 Fax 0191 2612952 City The The explanting of the valve: The valve was handed, still within the sterile field, to a scrub nurse. The scrub nurse was directed by a surgical registrar to remount the valve. The scrub nurse had neither training in or experience of remounting valves, but nevertheless remounted the valve as instructed: The valve was remounted in an inverted position:. The valve was then handed back to the primary surgeon who re-implanted the valve in an inverted position: Opportunities to identify the mistake and take appropriate remedial action were missed. Mrs Hynes suffered acute heart damage; which led directly to her death_ The Medicines and Healthcare Products Regulatory Agency were informed of the circumstances above on the 27 March 2015. They identified an opportunity for possible improvement of the design of certain valve holders and have confirmed that it is expected that by mid 2019 all such valves will be supplied only on unidirectional holders.

In my opinion action should be taken to prevent future deaths as follows:
1) Extensive training should be undertaken at all levels to ensure knowledge and understanding of the significance of manufacturer's instruction for use of medical products and any product design factors that may influence their use.
2) protocol should be established to facilitate junior members of an operating team to raise concerns when instructed to act outwith their experience and training:
3) The Trust should direct that in all future mechanical valve replacement procedures any valve explanted should be discarded and a new valve re-implanted: believe you Chief Executive of Newcastle Upon Tyne NHS Foundation Health Trust have power to take such action: