“During Mrs Hynes operation a direction was given to remount the Sorin Corbomedics 23mm…”
Dated 3 Jul 2017, from the coroner for Newcastle upon Tyne. Sent to 1 organisation or person.
A coroner wrote this report after an inquest, to warn the organisations below about a risk of further deaths.
The 56-day response deadline
Deadline passedReplies were due by 28 Aug 2017. A reply may have been sent and not yet published.
Organisations that receive a report must reply to the coroner within 56 days, saying what they will do or why they will do nothing. We show whether a response is published on judiciary.uk.
- Report dated3 Jul 2017
- Deadline28 Aug 2017
- Published on judiciary.uk3 Jul 2017
- Today23 Oct 2026
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Responses from each recipient
| Sent to | Response |
|---|---|
| The Newcastle Upon Tyne Hospitals NHS Foundation TrustNamed in the report as “Newcastle Upon Tyne NHS Trust” | Deadline passedNo response published on judiciary.uk so far. The 56-day deadline was 28 Aug 2017. A reply may have been sent and not yet published. |
The coroner’s concerns
This report was published as a scan, so its text was read automatically. Check the wording against the original before you quote it.
— (1) During Mrs Hynes operation a direction was given to remount the Sorin Corbomedics 23mm mechanical aortic valve on its holder whilst preparations to implant the valve were undertaken. Remounting the valve on its holder is contrary to the manufacturer's instructions for use. Concerns arising are: a) The rational for departing from the manufacturer's instructions for use was neither discussed nor recorded. b) The primary surgeon and operating team were unaware of the risks of departing from the manufacturer's instructions for use namely potential inverted remount. c) Ascrub nurse with neither training nor experience was instructed to remount the valve contrary to the manufacturer's instructions for use. The rational for this direction was neither discussed nor recorded. d) The primary surgeon with overall responsibility for the procedure did not instruct remounting of the valve; There are no recorded discussions with the primary surgeon on this issue. Lord Mayor’s Gallery, Civic Centre, Barras Bridge, Newcastle Upon Tyne, NEI 8QA Tel 0191 2777280 | Fax 0191 2612952 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths as follows: 1) Extensive training should be undertaken at all levels to ensure knowledge and understanding of the significance of manufacturer’s instruction for use of medical products and any product design factors that may influence their use. 2) A protocol should be established to facilitate junior members of an operating team to raise concerns when instructed to act outwith their experience and training. 3) The Trust should direct that in all future mechanical valve replacement procedures any valve explanted should be discarded and a new valve re-implanted. | believe you Chief Executive of Newcastle Upon Tyne NHS Foundation Health Trust have the power to take such action.
An extract. Read the full report, including the circumstances of the death, on the Courts and Tribunals Judiciary website.
- Source
- judiciary.uk, Prevention of Future Deaths reports, 2017-0448
- Added to Minute Book
- 8 Oct 2026
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Contains public sector information licensed under the Open Government Licence v3.0. Source: Courts and Tribunals Judiciary, judiciary.uk. Open Government Licence v3.0
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