Michael Walton

Minister of State for Health (Secondary Care)  

39 Victoria Street 
London 
SW1H 0EU 

18th September 2024 

Our ref: 

HM Coroner Georgina Nolan 
Newcastle and North Tyneside Coroners Court 
Lower Ground Floor 
Block 1 
Civic Centre 
Barras Bridge 
Newcastle upon Tyne 
NE1 8QH 

By email: 

Dear Ms Nolan,  

Thank you for the Regulation 28 Report of 4 July 2024 regarding the death of Michael Trevor 
Walton.  I  am  replying as  the  Minister with  responsibility  for  supply threats  and  disruption 
within the Department of Health and Social Care.  

I would like to say how saddened I am to read of the circumstances of Mr Walton’s death, 
and I offer my sincere condolences to his family and loved ones. The circumstances your 
report describes are concerning and I am grateful to you for bringing these matters to my 
attention.  

Matters of Concern 

Your report outlines a number of matters of concern, including that the surgeon’s preferred 
choice of cannula was not available for the procedure due to supply issues; that the cannula 
type contributed to its dislodgement from the lumen of the aorta, and to Mr Walton’s death; 
and,  that  using  sub-optimal  medical  equipment  poses  an  avoidable  risk  to  patients  of 
significant harm including death.  

Thank you for the additional time provided to the Department to provide a response to the 
concerns raised in the report. In preparing this response, Departmental officials have made 
enquiries  with  NHS  England  (NHSE), the  Medicines  and  Healthcare  products  Regulatory 
Agency (MHRA) and the Care Quality Commission (CQC). I understand that you have also 
requested  a  response  from  NHS  England,  which  will  provide  information  on  the  specific 
actions taken by the Newcastle upon Tyne Hospitals NHS Foundation Trust following the 
concerns you have raised about Mr Walton’s death.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
 
 Minister of State for Health (Secondary Care)  

39 Victoria Street 
London 
SW1H 0EU 

Medical Supply  

Medical supply chains are complex, global and highly regulated, making them vulnerable to 
a variety of shocks. Whilst we cannot always prevent supply disruption from occurring, there 
are a range of well-established processes and tools in place to help manage them when 
they do arise, and to help mitigate risks to patients.  

Guidance1 published in June 2024 by NHS England and available to all NHS Trusts sets out 
how to report potential supply disruptions of medical equipment and includes the escalation 
processes that NHS Trusts can follow in the event of a disruption. This guidance outlines 
that, in the event that an NHS Trust is not able to resolve supply disruption via local activity, 
the Trust can report the disruption to the Department’s National Supply Disruption Response 
(NSDR)2.   

The NSDR has been in place since December 2019 and acts as a single point of contact 
when an NHS Trust is experiencing supply disruption and has not been able to mitigate the 
disruption. Once a disruption has been reported to the NSDR, the Department will then work 
to help resolve the matter, including by:  

• 

liaising with the manufacturer of the product in question for details of the disruption 
and any recovery plans;  

•  contacting  NHS  Supply  Chain  or  other  distributors/wholesalers  that  stock  the 
product to determine whether any stock can be released to fulfil the NHS Trust’s 
immediate need; and,  
investigating alternative products and liaising with suppliers.  

• 

From a review of our records, we can confirm that supply disruption of the preferred choice 
of cannula for Mr Walton’s procedure was not escalated to the NSDR for support. 

Product Safety: 

I understand from the MHRA that central arterial cannula are acceptably safe when used as 
intended. Unfortunately, rare complications do still occur during interventional procedures. 
The MHRA have analysed available data and past records up to and including 17 July 2024 
and are not aware of any excess risk with the cannula used for Mr Walton’s procedure. For 
all devices on the UK market, the manufacturer must submit vigilance reports to the MHRA 
when reportable incidents that involve their device occur in the UK. The manufacturer must 
also take appropriate safety action when required and ensure their device meets appropriate 
standards of safety and performance for as long as it is in use. 

1 NHS England » Reporting potential supply disruptions of medical equipment and consumables 
2 Reporting to the National Supply Disruption Response (NSDR) - GOV.UK (www.gov.uk) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Minister of State for Health (Secondary Care)  

39 Victoria Street 
London 
SW1H 0EU 

Next Steps: 

The CQC have confirmed with my Department that they were made aware of Mr Walton’s 
death by the Trust and will be reviewing this information in line with their  specific incident 
process. They are requesting further information from the Trust accordingly.  

The CQC inspected the cardiothoracic department at Freeman Hospital in September 2023 
due to multiple concerns raised. The NHS Trust subsequently produced an action plan, and 
a quality improvement plan is now in place. As part of CQC’s ongoing regular engagement 
with the Trust, they will continue to monitor progress made. 

I hope this response is helpful. Thank you again for bringing these concerns to my attention.   

Yours sincerely,

Ms Georgina Nolan  
Senior Coroner  
Newcastle and North Tyneside  
Coroner’s Court 
Lower Ground Floor 
Block 1 Civic Centre 
Barras Bridge  
Newcastle upon Tyne 
NE1 8QH 

National Medical Director  
NHS England  
Wellington House 
133-155 Waterloo Road  
London 
SE1 8UG 

28 August 2024  

Dear Coroner, 

Re: Regulation 28 Report to Prevent Future Deaths – Michael Trevor Walton 
who died on 13 July 2023.   

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 4 July 
2024 concerning the death of Michael Trevor Walton on 13 July 2023. In advance of 
responding to the specific concerns raised in your Report, I would like to express my 
deep  condolences  to  Michael’s  family  and  loved  ones.  NHS  England  are  keen  to 
assure the family and the Coroner that the concerns raised about Michael’s care have 
been listened to and reflected upon.   

Your Report raised the concern over the risk posed to patients by medical equipment 
shortages  and  the  use  of  sub-optimal  medical  equipment.  In  Michael’s  case,  you 
raised that the operating surgeon’s preferred choice of cannula was not available due 
to supply issues, and this resulted in a cannula with a shorter tip being used, which 
ultimately contributed to its dislodgement and to Michael’s death.  

Nationally, NHS Resilience gets involved in supply disruptions where they receive an 
escalation.  These  come  in  from  either  NHS  Trusts  (via  NHS  England’s  Emergency 
Preparedness, Resilience and Response (EPRR) Teams), the Department of Health 
and Social Care’s (DHSC’s) National Supply Disruption Response (NSDR) Team or, 
less frequently, from NHS Supply Chain or NHS England’s Patient Safety Team.  

Whilst defined triggers for our  NHS Resilience involvement are in development and 
are not available to share, we consider (on a case-by-case basis) the potential risks 
to  patients  and  the  operational  delivery  of  NHS  services  of  a  break  in  supply,  how 
imminently  supply  disruption  will  occur,  and  the  availability  of  alternative  products, 
before  potentially  stepping  up  incident  management  arrangements  –  in  the  form  of 
either a full Incident Management Team (IMT) or a working group approach. Where 
NHS Resilience lead meetings, clinical input is used to help devise guidance on the 
use  of  alternative  devices,  the  preservation  of  existing  stock  through  changes  to 
practice, and to help coordinate national mutual aid, as required. 

Regarding this specific case and the Medtronic cannula product that was unavailable, 
NHS England does not believe (from a search dating back to 2021) that there was any 
escalation  of  a  shortage  to  the  national  team,  nor  a  referral  from  DHSC’s  NSDR 

                                                                                                                       
 
 
 
 
 
 
  
 
 
  
 function  stating  that  an  inability  to  source  this  product  was  causing  operational  or 
patient safety risks. 

NHS  Supply  Chain  colleagues  have  also  been  sighted  on  your  Report.  Many 
organisations order products through NHS Supply Chain, who aim to ensure adequate 
supply  for  demand  and  will  link  to  alternative  products  where  a  product  may  be 
unavailable.  Where  there  are  shortages,  these  are  communicated  through  an 
Important  Customer  Notice  (ICN).  All  NHS  Supply  Chain  shortages  are  tabled  at  a 
Supply Management Oversight Group (SMOG) which is chaired by DHSC.   

ICN 1832 was published on 26 October 2022, detailing transportation and logistical 
delays impacting availability across 56 Medtronic perfusion products. These impacted 
products  were  detailed  in  a  product  listing,  with  alternative  products  added  for 
consideration. The ICN detailed that customers needed to undertake appropriate due 
diligence to determine the suitability of alternatives listed. The 71424 (NPC FXA418) 
cannula, the preferred cannula of the operating surgeon in this case, had the following 
alternative  product  codes  listed  -  FXA413,  FXA355,  FXA206.  The  72224  (NPC 
FXA572) which was used was not listed as an alternative product for FXA418 by NHS 
Supply Chain in the ICN. It is however noted that the two cannulas are very similar in 
size, design and intended use.  

NHS  Supply  Chain’s  listing  of  alternative  products  is  limited  in  scope  and  does  not 
constitute advice. Decisions on the use of alternative products must be taken at local 
level.  

NHS  England  has  engaged  with  Newcastle  upon  Tyne  Hospitals  NHS  Foundation 
Trust on the concerns raised in your Report. We note that they state they were unable 
to determine the exact cause of the aortic cannula becoming dislodged, and that the 
default cannula choice was made for an operation of this nature. We note, however, 
that following Michael’s death, the Theatre Department have permanently suspended 
use of the cannula.  

I  would  also  like  to  provide  further  assurances  on  the  national  NHS  England  work 
taking  place around  the  Reports  to  Prevent Future  Deaths.  All  reports received  are 
discussed  by  the  Regulation  28  Working  Group,  comprising  Regional  Medical 
Directors,  and  other  clinical  and  quality  colleagues  from  across  the  regions.  This 
ensures  that  key  learnings  and  insights  around  events,  such  as  the  sad  death  of 
Michael, are shared across the NHS at both a national and regional level and helps 
us to pay close attention to any emerging trends that may require further review and 
action.   

Thank you for bringing these important patient safety issues to my attention and please 
do not hesitate to contact me should you need any further information.  

Yours sincerely,  

    
  
 
 
 National Medical Director