Patient died after device became trapped in him during an operation
PUBLISHED: 07:00 29 May 2019
A coroner has criticised a hospital trust over the death of a man who had a cardiac arrest after surgeons tried to remove a device trapped inside him during an operation.
Norman Pirie died at the Royal London Hospital in Whitechapel aged 90 after opting to get repairs to a stent in a blood vessel.
During the operation part of a "cuff device" failed to go into position properly and another section was released prematurely.
This meant the whole thing remained stuck inside Mr Pirie with no chance of surgeons pulling it out again.
The inquest into Mr Pirie's death held at Poplar Coroner's Court heard the only option was to perform 'high risk' open surgery to remove the device.
But Mr Pirie suffered a major loss of blood as a result of the op leading to a cardiac arrest. He died at about 3am on October 5, 2018.
The inquest found that the device - which wasn't faulty - was not used according to the manufacturer's instructions.
It should have been used at no more than a 60 degree angle but had been deployed at 68 degrees. Hospital staff told the court it was normal procedure on occasion to exceed the maximum.
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The inquest concluded Mr Pirie died from the consequences of the open surgery caused by the failure of the cuff device.
Assistant coroner, Edwin Buckett, has written to the Royal London's operator, Barts NHS Trust, to outline his concerns.
His prevention of future deaths report states: "Using the cuff device in that manner was taking a calculated risk although this was not an emergency, life-saving operation."
He highlighted two concerns: that the devices were not used according to limits laid down by the manufacturers and doing so increased the risk they would not deploy as expected
"In my opinion, there is a risk that future deaths will occur unless action is taken," Mr Buckett states.
A Barts Health NHS Trust spokeswoman said: "This was a sad case which the trust has thoroughly reviewed to identify if there is anything that we can learn to stop it happening again.
"The use of medical devices outside of instructions for use is an accepted NHS practice in patients who would otherwise have no option for treatment. Based on our clinical experience and world-wide research, in this case the decision to use this device was appropriate.
"These treatment options are always discussed by a panel of expert clinicians to ensure a thorough review, and patients are made aware of the potential risks and benefits.
"However, with the safety of patients our paramount concern, we have now instituted a further detailed technical review to ensure full consideration of any risks during clinical discussions."