Sudden death of woman after routine surgery linked to use of blood clotter, inquest told

An inquest has heard claims that the sudden death of a woman following a routine operation to remove an ovarian cyst three years ago was linked to her being administered with a blood-clotting powder that was not recommended for use in gynaecological surgery.

Linda Connell (41), a married mother-of-one from Lackanash, Trim, Co Meath, died from a rare blood disorder at Beaumont Hospital on March 11th, 2020 after becoming unwell following minor surgery five days earlier at Our Lady’s Hospital in Navan.

A sitting of Dublin District Coroner’s Court on Thursday heard a version of EndoClot – a blood-clotting powder – had been used during the surgery, although the product is only designed for use in the gastrointestinal tract.

Consultant gynaecologist Dr Sahar Ahmed, who carried out the surgery on Ms Connell, said she had asked theatre staff at Our Lady’s Hospital for the blood clotting product that she would normally use but it was unavailable and was provided instead with EndoClot.

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Dr Ahmed said there was nothing unusual with being given similar products in theatre.

She recalled there was no active bleeding from the patient but she wanted to stop some “oozing” from Ms Connell’s uterine wall.

Dr Ahmed said the surgery on Ms Connell was a bit more than expected as one of her tubes was twisted and distorted. However, the consultant said the situation was “manageable” and the patient had been fit for discharge as planned later that day.

She told the inquest that she did not think there was any link between what happened to Ms Connell and the use of EndoClot until 18 months later, when she became aware of a similar incident involving another patient and use of the blood-clotting powder at Our Lady’s in Navan.

In reply to questions from the coroner, Clare Keane, Dr Ahmed said EndoClot, which was withdrawn from use in Our Lady’s, seemed to be the only link between the two cases.

Asked by counsel for Ms Connell’s family, Alistair Rutherdale BL, instructed by Callan Tansey solicitors, if she would have avoided using EndoClot on Ms Connell if she knew then what she knew now, Dr Ahmed replied: “100 per cent”.

A consultant haematologist at Beaumont Hospital, Professor Siobhan Glavey, said Ms Connell had been diagnosed with thrombotic microangiopathy (TMA) – a rare life-threatening condition where microscopic clots form in blood vessels – after being transferred from Our Lady’s in Navan on March 9th, 2020.

The consultant told the inquest such a condition was “vanishingly rare” and was so unusual that the hospital had consulted with international experts about Ms Connell’s care.

Donal O’Connor, clinical manager of medical devices with the Health Products Regulatory Authority, told the inquest there was an explicit instruction that the version of EndoClot used on Ms Connell should only be used for surgery on the gastrointestinal tract.

However, Dr O’Connor acknowledged that other versions of EndoClot, which are specifically only recommended for use with the gastrointestinal tract, were similar to other blood-clotting products that could be used in other parts of the body.

Dr O’Connor said the HPRA became aware of the concerns about Ms Connell’s case and one other similar incident in July 2021 and it subsequently issued an advisory notice to raise awareness of what happened and to encourage reporting of similar clinical incidents.

However, he said the notice was not specifically “about EndoClot”.

Dr O’Connor said no causal association had been established between EndoClot and what happened to Ms Connell but added that did not mean there was no link in the case.

Ms Connelly’s husband, David Freeman, told the hearing his wife had gone for a simple gynaecological procedure and ended up losing her life.

Mr Freeman said he was attending the inquest as “a voice” for his wife and to try to get answers for her and her family because he firmly believed that “she deserved better.”

He told the coroner that the tragic death of “a much-loved wife, mother and only child” – who came originally from Swords, Co Dublin – had a devastating impact on himself, her son, Joshua and her parents, Philp and Breda.

The inquest heard that the couple were childhood sweethearts who reconnected in their adult life and had been married for four years.

The inquest heard Ms Connell, who had worked with children in foster care, was due to graduate from UCD in the field of childhood drug and alcohol abuse.

A pathologist, Christian Gulmann, said a post-mortem showed Ms Connell had died from TMA but he could not explain its exact cause.

Dr Gulmann said it was possible it was linked to the oozing from where surgery had been performed on the patient.

Mr Rutherdale called for a verdict of medical misadventure on the basis there was sufficient evidence that EndoClot had “triggered a devastating cascade” in the deceased.

However, Cathal Murphy BL, for EndoClot Plus, the US manufacturer of the powder, claimed no link had been established between a product used extensively across Europe and what happened to Ms Connell. Mr Murphy said there were multiple potential causes of TMA.

At the end of the hearing, Mr Freeman and other members of Ms Connell’s family reacted emotionally as the coroner returned a verdict of medical misadventure.

Although Dr Keane stressed that the inquest could and would not attach blame for what was “a very complex case,” she said there was a link in time between the procedure in Our Lady’s Hospital and subsequent events.