Prevention of Future Deaths reports · 2017

Muriel Brett

Regulation 28 report to prevent future deaths, reference 2017-0150, written 4 May 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report4 May 2017
Reference2017-0150
DeceasedMuriel Brett
CoronerAndrew Cox
Coroner areaPlymouth, Torbay and South Devon
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Organisation namedUniversity Hospitals Plymouth NHS Trust
Sourcejudiciary.uk record · original PDF
Responses publishednone published

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

ANDREW JAMES COX
Assistant Coroner for Plymouth Torbay and South Devon

REGULATION 28 REPORT TO PREVENT FUTURE DEATHS

THIS REPORT IS BEING SENT TO: Medicines Regulatory Healthcare Authority,
151 Buckingham Palace Road, Victoria, London SW1W 9SZ

CORONER

! am ANDREW JAMES COX, Assistant Coroner for Plymouth Torbay and South Devon

CORONER’S LEGAL POWERS

| 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.

http://www. legislation.gov.uk/ukpga/2009/25/schedule/5/paragraph/7

http://www. legislation.gov.uk/uksi/2013/1629/part/7/made

INVESTIGATION and INQUEST

On 29 March 2016 | commenced an Inquest into the death of Muriel Ann Brett, 69. This
concluded at the end of the Inquest hearing on 26 April 2017. The conclusion of the inquest was
that Muriel had died from a known but rare complication of an elective surgical procedure. The
medical cause of death was given as :

1 (a) Right Pneumonia;

1 (b) Perforated Oesophagus (stented);

1 (c) Valvular Heart Disease (Operated 11 March 2016 and 12 March 2016)

CIRCUMSTANCES OF THE DEATH
Muriel suffered with severe aortic stenosis. She underwent an aortic valve replacement
procedure on 11 March 2016. At surgery the first replacement valve was felt by the operating
Surgeon to be defective. It was explanted and a second replacement valve then implanted.

Muriel underwent a second operation on 12 March 2016 at which time blood and clots were
removed to prevent the risk of cardiac tamponade.

Muriel underwent three transoesophageal echocardio graphs (TOE) on different dates by
different clinicians.

On 20 March 2016 an oesophageal perforation was identified which was stented. | found that it
was more likely than not that the cause of the perforation was the insertion of the probe at one of
the TOE procedures. it was not possible to say from the evidence which examination had
caused the perforation. Muriel sadly deteriorated and died in Derriford Hospital, Plymouth on 20
March 2016.

Subsequent investigation carried out independently on behalf of Edwards Lifesciences (of the

explanted valve) had been unable to identify any defect with it.
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.

1 Derriford Park, Derriford Business Park, Plymouth, PL6 5QZ
Tel 01752 204636 | Fax

The MATTERS OF CONCERN are as follows. —

[(1) It is of concern that a valve implanted at cardiac surgery was felt by the operating surgeon
to be defective;

(2) It is further of concern that an independent review of the explanted valve did not reveal a
defect, in contrast to the view of the operating surgeon.

Please now find enclosed copies of the following:

1. Statement of EE. osutan Surgeon
2. Report entitled “Evaluation of CER 2016 — 02926-1 Model 3300TEX Sixe 21 Carpenter-
E's Pericardial Aortic Bio prosthesis prepared i
dated November 10 2016;
3. Note of telephone conference dated 7 February 2017.

ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you Medicines
Regulatory Healthcare Authority have the power to take such action.

YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report, namely by
28 June 2017. 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.

COPIES and PUBLICATION

| have sent a copy of my report to the Chief Coroner and to the following interested Persons the
family of the deceased, Plymouth Hospitals NHS Trust and Edwards Lifesciences.

lam also under a duty to send the Chief Coroner a copy of your response.

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.

Assistant Coronel lymouth Torbay and South Devon

1 Derriford Park, Derriford Business Park, Plymouth, PL6 5QZ
Tel 01752 204636 | Fax

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