The Trust has implemented a new SOP to address concerns regarding risk stratification and surgical support. The SOP includes a formalised system of risk stratification, defined surgical input, and arrangements for timely cardiac surgical team attendance. (AI summary)
Source · Prevention of Future Deaths
Gemma Poterajko
Ref: 2025-0351
Date: 10 Jul 2025
Coroner: Elizabeth Didcock
Area: Nottinghamshire
Responses identified: 1 / 1
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The absence of formal risk stratification and a written Standard Operating Procedure for lead extraction led to unclear planning and inadequate timely cardiac surgical team support during procedures.
Date
10 Jul 2025
56-day deadline
4 Sep 2025 est.
Responses identified
1 of 1
Coroner's concerns
The absence of formal risk stratification and a written Standard Operating Procedure for lead extraction led to unclear planning and inadequate timely cardiac surgical team support during procedures.
View full coroner's concerns
1. The lack of a formalised documented system of risk stratification for Lead extraction. The consequence is that there is a lack of clear planning for what may be needed from the cardiac surgical team, in terms of urgent surgical expertise, theatre staff support and perfusion team support, for any given lead extraction
2. The lack of a written Trust Standard Operating Procedure for Lead extraction that includes a record of the planning discussion, and sets out realistic cardiac surgical involvement when this is necessary
3. The lack of clarity as to how the full cardiac surgical team can within their resources currently, or planned for, provide necessary attendance in a timely way at a given Lead extraction procedure, as per international expert consensus I am not reassured that necessary actions to address these serious issues identified are in place.
2. The lack of a written Trust Standard Operating Procedure for Lead extraction that includes a record of the planning discussion, and sets out realistic cardiac surgical involvement when this is necessary
3. The lack of clarity as to how the full cardiac surgical team can within their resources currently, or planned for, provide necessary attendance in a timely way at a given Lead extraction procedure, as per international expert consensus I am not reassured that necessary actions to address these serious issues identified are in place.
Responses
Nottingham University Hospitals NHS Trust
NHS / Health Body
Action Taken
Dear Dr Didcock Inquest: C/2024/113 Regulation 28: Prevention of Future Deaths Report [PFDR] Response I am writing in my capacity as Medical Director of Nottingham University Hospitals NHS Trust in response to the Prevention of Future Death Notice issued on 10 July 2025 following the sad death of Mrs Gemma Louise Poterajko. May I begin with offering my sincerest condolences to Mrs Poterajko’s family for their loss. I am deeply sorry for the missed opportunities and issues that were highlighted during the Inquest. The concerns you have raised have been taken extremely seriously. Please find attached a commentary in response to the Prevention of Future Deaths Report issued to Nottingham University Hospitals NHS Trust following the Inquest into the death of Mrs G Poterajko. The actions either taken or planned in response to the learning from the Inquest are summarised below. The oversight of the delivery of these actions will be through our Quality and Safety Governance Committees, with Executive oversight - Committees of our Board will receive a progress report. I hope that this commentary provides assurance that we are committed to learning from this, and other incidents to significantly enhance the care of patients across the Trust.
Report sections
Investigation and inquest
On 23.8.24, I commenced an investigation into the death of Mrs Gemma Louise Poterajko The investigation concluded at the end of the inquest on the 27th June 2025 The conclusion of the inquest was a narrative as follows: Gemma died from a rare, unexpected, but recognised complication of a pacemaker lead extraction. She died from multi organ failure caused by catastrophic haemorrhage from two venous tears in the left innominate vein and left subclavian vein, sustained during the lead extraction. No identified issues of care have, on balance, caused or made a more than minimal, negligible or trivial contribution to her death.
Circumstances of the death
Gemma died on 22.8.24 at the City Hospital in Nottingham following a pacemaker Lead Extraction procedure. During the advancement of the Tightrail cutting sheath used to cut through fibrous scar tissue surrounding the lead, to aid lead extraction, the cutting blades likely caused two tears in the wall of the left subclavian and left innominate veins. These tears occurred at sometime between 14.35 and Gemma’s collapse with low blood pressure at 14.48 hours on that day. Whilst the exact mechanism of venous tearing is unclear, and is a very unusual occurrence, the vein walls were likely to be additionally vulnerable because of the stuck fibrous tissue around the pacemaker lead also being stuck to the vein inner wall. No evidence of careless or incorrect technique has been established to have led to these tears. Bleeding from these tears was catastrophic, likely the most significant bleed being from the higher tear in the subclavian vein, where the Tightrail sheath was found protruding from the vein at 16.55 hours. The first venous tear was found at 16.11.hours. Managing events from 14.48 onwards was challenging for the team of senior clinicians present, as there was a need to search for and potentially deal with, a more common bleeding site, that is from the Right Atrium or from a Superior Vena Cava tear, before a higher venous tear was considered. Rendering all appropriate resuscitative measures, including cardiopulmonary bypass was necessary before further bleeding sites were searched for, as Gemma had such a profound circulatory collapse with a cardiac arrest at 15.00 hours requiring ongoing cardiac compressions and full and continuing advanced life support. The extent of bleeding from the venous tears was likely unsurvivable once it had occurred, although it was entirely appropriate to continue all measures to try and save Gemma’s life up until sadly the situation was futile with evidence of established multi organ failure later that evening.
Inquest conclusion
Gemma died from a rare, unexpected, but recognised complication of a pacemaker lead extraction. She died from multi organ failure caused by catastrophic haemorrhage from two venous tears in the left innominate vein and left subclavian vein, sustained during the lead extraction. No identified issues of care have, on balance, caused or made a more than minimal, negligible or trivial contribution to her death.
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Report details
- Reference
- 2025-0351
- Date of report
- 10 July 2025
- Coroner
- Elizabeth Didcock
- Coroner area
- Nottinghamshire
Responses identified
Responses identified
1 of 1
All listed responses identified
Organisations named in PFD reports are normally expected to respond within 56 days. Deadline: 4 Sep 2025 (estimated).
Sent to
- Nottingham University Hospitals NHS Trust