Stephen Whitehead · Prevention of Future Deaths report

On the 9th March 2018 I commenced an investigation into the death of Stephen Whitehead. The investigation was concluded by way of inquest on the 25th June 2018.

The medical cause of death was:

1a) Septicaemia
1b) Bacterial ascending cholangitis
1c) Common bile duct calculi and stent
2) -

I recorded a narrative conclusion:

‘Died as a result of complications arising from an indwelling biliary stent. The stent had unintentionally been left in situ for a prolonged period and he deceased lost to follow up.

Neglect more than minimally contributed to his death.’

In October 2015 the deceased was admitted to hospital. A diagnosis of acute obstructive jaundice was made. He underwent an ERCP with stent insertion. Plans were subsequently made for further surgery on the 24th December 2015 but deferred at the deceased’s request.

On the 15th February 2016, the deceased underwent a laparoscopic cholecystectomy. The operation and immediate post-operative period were uneventful. A further post-operative ERCP to remove the stent and a large gall stone was to be scheduled for 2 months’ time.

On the 4th March 2016 the deceased attended hospital, as an emergency admission, with biliary obstruction. Treatment was administered and plans made to discharge and to re-admit on an elective basis for further intervention. He was re-admitted on the 15th March 2016 for an ERCP and stent change, with a follow up ERCP to be scheduled 6 weeks thereafter. An on-line booking from was not completed in this regard, resulting in the deceased not being recalled. The stent remained in situ for almost 2 years.

At the material time, the Hospital Trust had multiple booking processes for repeat ERCPs.

On the 6th February 2018 the deceased was admitted to the Emergency Department (ED) with abdominal symptoms. There was delayed recognition of the signs of sepsis. This error did not more than minimally contribute to the deceased's demise. Intensive treatment was instigated and the deceased transferred to ITU. It was not possible to carry out a CT scan as he was too unstable.

Despite best efforts, the deceased continued to deteriorate and died in hospital on the 8th February 2018.

Whilst the local NHS Trust has taken (and continues to take) significant steps to improve patient safety with regard to biliary stent insertion/management, I am concerned about the wider implications, namely:

1. The absence of a national ‘safety-netting’ system (stent registry), akin to that already established for ureteric stents (a web-based registry). There is no equivalent for biliary stents. Without a safety netting system, I am concerned that there is a real risk that patients will remain susceptible to what is medically recognised as the ‘phenomenon of the forgotten biliary stent’, resulting in future deaths.

2. Definition of ‘short-term’ in clinical guidance - during the course of the evidence I heard that National Guidelines on the management of common bile duct stones currently indicates that the short term use of endoscopic biliary stents followed by further ERCP (or surgery) is an established and safe management option. However, the guidelines do not provide an operational definition of ‘short term’. It is therefore unclear as to what is ‘safe’ in terms of timeframe.