Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0351, written 10 Jul 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 10 Jul 2025 |
|---|---|
| Reference | 2025-0351 |
| Deceased | Gemma Poterajko |
| Coroner | Elizabeth Didcock |
| Coroner area | Nottinghamshire |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Nottingham University Hospitals NHS Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. The Chief Executive, Nottingham University Hospitals NHS Trust 1 CORONER I am Dr Elizabeth Didcock, Assistant Coroner, for the coroner area of Nottinghamshire 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 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. 4 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. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: 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. 6 ACTION SHOULD BE TAKEN In my opinion, action should be taken to prevent future deaths and I believe you have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by the 4th September 2025. I, the Coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 . COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: 1. The family I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any person who I believe may find it useful or of interest. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response by the Chief Coroner. 9 10th July 2025 Dr E. A. Didcock
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Please ask for the Medical Director’s Personal Assistant 1 September 2025 Dr Elizabeth Didcock HM Assistant Coroner for Nottingham City and Nottinghamshire HM Coroner’s Court The Council House Market Square Nottingham NG1 2DT Dear Dr Didcock Medical Director’s Office 3rd Floor, Trust Headquarters City Hospital Campus Hucknall Road Nottingham NG5 1PB 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. Yours sincerely Medical Director [NUH] Enc Concerns identified through the PFD The Coroner remained concerned regarding there were outstanding matters that gave rise to concern that future deaths will occur, as follows: 1. The lack of a formalised documented system of risk stratification, (which of course includes clinical judgment by the highly experienced extractors) that currently means there is a lack of clear planning for what is likely to be needed from the cardiac surgical team, in terms of 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 as per international expert consensus. Response to Regulation 28 Concerns – Lead Extraction Procedures Following the recent Inquest regarding the sad death of Mrs Gemma Louise Poterajko as a result of a transvenous lead extraction (TLE), we acknowledge your concerns and have now developed and implemented a formal Standard Operating Procedure (SOP) for TLE at the Trent Cardiac Centre, Nottingham University Hospitals NHS Trust. This SOP has been drawn from the British Heart Rhythm Society (BHRS) Standards for Lead Extraction (2018). I set out below our response to each of the areas raised: 1. Lack of a formalised documented system of risk stratification The SOP introduces a structured Green / Amber / Red risk stratification system that guides planning for each procedure. This system considers factors such as lead dwell time, type of lead, number of leads, patient co-morbidities, and surgical history. It incorporates validated scoring tools (EROS and SAFETY-TLE) alongside consultant clinical judgment. Each risk category has defined requirements for surgical expertise, theatre support, and perfusion team readiness. This ensures that every case is supported by a clear, documented, and auditable plan, reducing the risk of unanticipated complications. 2. Lack of a written Trust SOP including planning discussions and cardiac surgical involvement We have now published a formal Trust-wide SOP that sets out the process for multidisciplinary team (MDT) review and planning. All cases are reviewed at a dedicated TLE MDT, with outcomes recorded in the clinical record. Where complexity is anticipated (such as prior sternotomy, significant vegetations, or hybrid procedures), discussion occurs at the joint cardiology–cardiac surgery MDT. The SOP specifies the level of cardiac surgical involvement: Green cases: on-call cardiothoracic team cover. Amber cases: advance coordination with cardiac surgery, confirmation of availability at 08:00 surgical briefing, and sternotomy trolley prepared. Red cases: full cardiac surgical team (consultant surgeon, scrub nurse, perfusionist) physically present in the procedure laboratory for the entirety of the case. This provides a documented, standardised process that ensures realistic and appropriate surgical support is present when required. 3. Lack of clarity regarding timely surgical attendance and resource provision The SOP provides explicit clarity on how timely surgical attendance will be assured: For Amber and Red cases, the cardiac scheduling team liaises directly with cardiac surgery scheduling in advance to confirm team availability. At the 08:00 cardiac theatre briefing, roles and responsibilities are agreed, and a bailout plan is confirmed. For Red cases, the named surgical team, including consultant surgeon, anaesthetist, perfusionist, and scrub staff, is physically present and set up in the catheter laboratory before the procedure commences. The SOP also mandates readiness of emergency equipment (including sternotomy trolley, Bridge balloon system, and cross-matched blood) to enable immediate intervention in the event of major complications. Conclusion We are confident that the new SOP directly addresses the concerns raised by ensuring: A formalised and transparent system of risk stratification. A Trust-wide SOP with clear planning, MDT involvement, and defined surgical input. Clear arrangements for timely cardiac surgical team attendance and resource allocation. We are grateful for your observations, which have strengthened our processes and patient safety measures. Please do not hesitate to contact me should you require any further clarification.
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