Record Of Investigation Into Death (Without Inquest)
Coroners Act 1995
Coroners Rules 2006
I, Stephen Raymond Carey, Coroner, having investigated the death of
Raelene Judith WOOLLEY
WITHOUT HOLDING AN INQUEST
(a) The identity of the deceased is Raelene Judith Woolley (Mrs Woolley) who died between 2 and 3 September 2008 at 78 Linden Road, Primrose Sands, Tasmania.
(b) Mrs Woolley was born in Australia on 6 May 1959 and was aged 49 years.
(c) Mrs Woolley was separated from her husband and was unemployed at the time of her death.
(d) Mrs Woolley died as a result of:
i) Haemoperitoneum/retroperitoneal haematoma
ii) Laceration of left external iliac artery
iii) Angioplasty and stent placement
iv) Severe atherosclerotic peripheral vascular disease; history of claudication
Circumstances Surrounding the Death :
Mrs Woolley was admitted to the Royal Hobart Hospital (RHH) on 1 September 2008 for a surgical procedure involving an angioplasty and a stent placement. She was discharged on 2 September 2008.
Ms Janifer Smith, Mrs Woolley’s Aunt, collected Mrs Woolley from hospital on 2 September 2008 at approximately 1.00pm. She took her home and then visited with her to the home of Mrs Wolley’s neighbour, John Blythe. Mrs Woolley had two glasses of white wine during this visit and complained of pain in her abdomen. Due to Mrs Woolley’s discomfort Ms Smith assisted her return to her home and to bed. Mrs Woolley got out of bed at approximately 5.00pm to see her father and daughters-in-law who had called to visit and who stayed for half an hour. Ms Smith left at this time and Mrs Woolley assured her that she was"all right".
Mrs Woolley called her son, Mr Scott Dawes at approximately 4.30pm on 2 September 2008 to request that he assist her light a fire and prepare for bed. Mr Dawes states that he went to Mrs Woolley’s home between 6.00pm and 7.00pm. In his opinion his mother looked "very sweaty and like she was in pain". He attended to her fire and put the television on for her and gave her a bucket in case she became unwell. When he attended his mother’s home the next morning at approximately 10.30am the curtains were closed. He unlocked the door and noticed Mrs Woolley was still on top of her bed. She was cold and bloated. Emergency services were called at 10.47am arriving at the residence at 11.23am. Given the clinical observations consistent with death, resuscitation was not initiated.
Constable T Stevens, Tasmania Police attended the address at approximately 11.00am and initiated an investigation. He noted Mrs Woolley to be lying on top of the bed in the main bedroom of the residence. A drawer containing various medications was open next to the bed. There were no obvious signs of trauma and it was noted that Mrs Woolley’s son had unlocked the door to gain entry.
Dr R Prasad, General Practitioner, Kingston Town Medical Centre first treated Mrs Woolley in November 2001 and last saw her on 12 June 2008. He reports a history of severe anxiety and panic attacks together with peripheral vascular disease. At her last consultation on 12 June 2008 Dr Prasad was counselling Mrs Woolley in respect of ceasing smoking.
Dr H Perry, General Practitioner, Richmond Medical Centre first consulted Mrs Woolley on 11 July 2008 following her relocation to the area following her separation from her husband. Mrs Woolley was last seen by Dr Perry on 22 August 2008. Dr Perry noted Mrs Woolley’s high level of anxiety and depression attributing these to in some part her financial constraints and her concerns for her relationship with her children. Dr Perry did not believe that Mrs Woolley was at a high risk of self harm.
Mr David Stary, Vascular and General Surgeon at the Launceston General Hospital (LGH) and the Royal Hobart Hospital (RHH) first saw Mrs Woolley on 7 August 2008 as a vascular outpatient at the Specialist Clinic at the RHH. He reports:
"She had a history of increasingly disabling short distance calf claudication (worse in the left) secondary to an occlusion of her left external iliac artery found on a recent arterial Doppler Study. Clinically she had an ischaemic left foot with no pulses palpable in that leg."
Mr Stary discussed treatments options with Mrs Woolley and reports that:
"On the 1 of September in the RHH Angio Suite, under local anaesthetic, via a puncture of her left groin, an angiogram was performed confirming the ultrasound finding of an occluded proximal external iliac artery. Using a Vanchie 2 catheter and glide wire this lesion was crossed and then primarily stented with a 6 x 6 Nitenol self deploying stent (Smart). For occlusive disease of the iliacs simple balloon angioplasty has a higher reocclusion (due to arterial recoil) and indeed this was the case following Mrs Woolley’s balloon angioplasty in 2006. A Nitenol self-deploying stent is considered much less traumatic and less likely to rupture an artery than a balloon mounted stent".
"Following ballooning of this stent with a 5 x 4 balloon Mrs Woolley complained of some left flank plain and she was noted to have a drop in her systolic pressure to 60. An immediate MET (Medical Emergency Team) call was activated at around 2.30pm and a subsequent angiogram indicated a small puff of contrast from the proximal stent indicating some extravasation (bleeding). The 5 x 4 balloon was then used to tamponade this area and on two subsequent repeat angiograms there was no evidence of any leakage or extravasation of contrast. Mrs Woolley’s blood pressure came up quite rapidly after a small IV bolus (130/80)."
After discussion with the resuscitation team Mrs Woolley was admitted to the surgical ward overnight for observation to check for heart problems and monitor for ongoing issues.. At that stage Mr Stary reports that it was felt that "the small bleed from her stented external iliac artery may have triggered a vaso vagal episode or possibly a myocardial ischaemic event or possibly this was secondary to an allergic reaction"
Mrs Woolley’s condition remained stable overnight. On 2 September 2009 Mrs Woolley was reviewed by by Dr Chris Hutchinson (Consultant Physician) who found no evidence of heart problems. She was also reviewed by the Vascular Surgery Registrar. Up until the discharge there was no evidence of ongoing issues relating to the angioplasty. Mrs Woolley was discharged with an appointment to be reviewed in the RHH Specialist Clinic in two weeks time.
It is obvious that within a very short period of time from discharge that Mrs Woolley was exhibiting possible signs of internal bleeding.
It appears likely that the initial haemorrhage had been stabilised and contained given that there were no indications of any ongoing problem during her overnight stay in hospital. However upon discharge and subsequent mobilisation any thrombus that had formed over the arterial wound may have dislodged leading to further haemorrhage.
Dr Donald Ritchey, Forensic Pathologist, Statewide Forensic Medical Services conducted the autopsy of Mrs Woolley. Dr Ritchey reports:
"A 5mm laceration was in the left external iliac artery overlying the metallic intravascular stent. The laceration caused copious retroperitoneal haematoma and haemoperitoneum (internal bleeding) leading to death."
I sought opinion as to whether there was a better method to treat a primary haemorrhage as occurred in this case to better ensure that a secondary haemorrhage did not occur. Prof Anthony Bell, The Chief Medical Officer at the RHH, although conceding he was not an expert in this field, stated that upon his discussion with such experts the view was that instead of a balloon tamponade as used in this case, the use of a "covered stent" was a better method to ensure a secondary haemorrhage does not occur.
However Dr Stary, upon discussion with Dr Mykatovitch, the vascular interventional radiologist present, determined not to proceed in that manner as it required the insertion of a much bigger sheath into the groin artery and increases the risk of damage to the artery and bleeding upon removal of the sheath. He also noted that the other method would have been to proceed to open operation and repair of the artery. He asserts that both these more invasive interventions are reserved for situations where there was an ongoing bleed that could not be controlled by balloon tamponade.
I am satisfied that a full and detailed investigation has been undertaken in relation to the death of Mrs Woolley and that there are no suspicious circumstances.
Mrs Woolley died as a result of a laceration in the left external iliac artery overlying the metallic intravascular stent which caused retroperitoneal haematomoa and haemoperitoneum.
I accept that there are general risks associated with endovascular intervention.
Mr Stary discussed the use of a covered stent graft with Dr Mykatovitch, Vascular Interventional Radiologist and both believed that in Mrs Woolley’s case it was not appropriate. I accept Mr Stary’s assertion that the use of a covered stent did not eliminate the risk of a late haemorrhage as a similar tear can occur at the proximal or distal end of the stent graft. I also accept that to his knowledge this is the only incident of which he is aware where such a major haemorrhage has occurred with a delay of over 24 hours. I also accept that there were no clinical indications of any ongoing haemorrhage or heightened risk of haemorrhage at the time of Mrs Woolley’s discharge from hospital.
I am aware that this death contributed to an independent investigation into Vascular Surgery Outcomes at the Royal Hobart Hospital. A number of recommendations were made as to matters that will ensure the highest quality surgical treatment.
Decisions and actions by surgeons during an operative procedure are matters for the surgeon’s professional and clinical judgement. Given the general practice in operations of this type and the successful stemming of the initial haemorrhage by a conservative method I see no reason to question the manner or type of procedure conducted. The ultimate outcome was totally unexpected to all involved.
One recommendation that I do make concerns the information that may or may not have been given to Mrs Woolley and her carer upon discharge. I am unaware of what information may have been provided but I believe it is of fundamental importace that following medical procedures, in particular surgical procedures, that patients and those to whom care they are discharged are advised what to do and who to contact when there is a deterioration in their health subsequent to discharge. This is especially the case where the procedure has not proceeded in the range of normal expectation with some form of complication as in this case. I am unaware of whether Mrs Woolley was given such advice but if she had been and had heeded that advice when she first exhibited signs of distress during the afternoon on 2nd September 2008 it is possible that the outcome for her may have been different.
I wish to conclude by conveying my sincere condolences to the family of Mrs Woolley.
DATED: 13 January 2011 at Hobart in the State of Tasmania.