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Investigation and inquest
On 17.5.19 I commenced an investigation into the death of Andrew Cook, age 53. The investigation concluded at the end of the inquest on 16.6.21. The Medical Cause of Death was: 1a) Anaphylaxis reaction during percutaneous coronary intervention for ischaemic heart disease.
The narrative conclusion was: Died of anaphylaxis during a medical procedure.
Circumstances of the death
On 31 March 2019 Andrew Cook underwent percutaneous coronary intervention at Kettering General Hospital following a myocardial infarction. During the procedure he suffered anaphylaxis leading to cardiac arrest and attempts at resuscitation were unsuccessful.
Mr Cook had a previous diagnosis of allergy to PEG (polyethylene glycol) and some of the equipment used during the procedure was coated with PEG to act as a lubricant. Although it was not possible to draw a conclusion on the balance of probabilities, the evidence at the inquest suggests that it might have been exposure to this PEG which caused the anaphylaxis.
Coroner’s concerns
(1) PEG allergy is rare but may be under-reported. PEGs are ubiquitous and more research into their effect as allergens is required.
(2) Whether the existence, dose and molecular weight of PEG should be made clear on medical product information (such as the Instructions For Use, data sheets, packaging and marketing information).
The existence of PEG in the equipment (in this case, the Sion and Sion Blue guidewires manufactured by Asahi Intecc) was not apparent from the packaging or product information available to the clinicians.
PEGs are available in various molecular weights. There was expert evidence that reaction to PEG may depend on the dose and exact molecular weight to which an individual is exposed.
It was acknowledged that labelling can have negative effects and therefore needs to be considered with care. Labelling also requires coordination with other national regulators.
(3) There is inconsistency and potential confusion in nomenclature. For example, PEG can be referred to as “Macrogol”, “polyethylene oxide” (PEO) or “polyoxyethylene” (POE). Nomenclature may also vary between countries. There was evidence that clinicians reviewing product information in urgent situations are not aware of the various synonyms.
Information checked against the published report and official responses