Decision Report 201908401

Summary

C complained on behalf of their late sibling (A). A was admitted to hospital to have their pacemaker and the leads, which attach it to the heart, extracted. There was a 2-3% risk of major bleeding and A signed a consent form for the procedure. During the operation, the surgeon successfully removed one of the pacemaker leads but whilst attempting to remove the final two, A's blood pressure suddenly dropped. This was recognised by the anaesthetist and the major haemorrhage protocol was activated. An emergency call for surgical assistance was placed. Despite chest compressions and fluids, staff were unable to stop the bleeding and A died. When the surgeon had tried to remove one of the leads, a tear had been created in one of the major veins around the heart. C complained that the surgery had not been carried out to a reasonable standard.

We took independent advice from a consultant cardiologist (a doctor that specialises in diseases and abnormalities of the heart). A's pacemaker, at several years old, would be well embedded in scar tissue. There was infection at the site, and the device was pushing through the front wall of A's chest. There were other options for treating this, but laser lead extraction was the best option for a long-term recovery. The operation appeared to have been carried out reasonably, with staff taking prompt and appropriate action when A's blood pressure dropped. There was nothing more the staff could have done to save A's life once the bleed occurred.

We did raise concerns about the consent process. We noted that A had signed a consent form on the day and the risk of major bleeding was noted. However, the board should have used a more detailed consent form with other fields, including alternative treatment options, and that consent should have been obtained prior to the day of surgery as well as the day of it. On balance, we did not uphold the complaint as the evidence indicated that the standard of A's surgery was reasonable.