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An Italian toddler has tragically died after receiving a 'frostbitten' heart in a transplant, the family's lawyer has said.
Two-year-old Domenico had been on life support for two months, but passed away on Saturday morning after suffering an 'irreversible worsening of his clinical condition'.
Prosecutors have launched an investigation, with six medics under formal scrutiny, amid suspicions the donor organ was mistakenly transported in dry ice, causing serious tissue damage.
Lawyer Francesco Petruzzi told reporters: 'It's over. Domenico is gone,' and that a foundation would be set up in his name.
Domenico was born with cardiomyopathy - a degenerative disease that thickens the wall of the heart until it no longer pumps blood effectively.
After a desperate wait on the waiting list, a donor heart was found in December from a four-year-old boy, who had drowned in a swimming pool in Bolzano in the Italian Alps.
It was delivered to Monaldi Hospital in Naples and transplanted into Domenico on December 23, but it failed to ever function properly.
Patrizia Mercolino, his mother, previously told The Times: 'They called me after the operation to say, "There is a problem — the heart does not start". I didn't ask too many questions.'
Patrizia Mercolino, mother of Domenico, leaving Monaldi Hospital in Naples after his death on Saturday
Ms Mercolino had previously pleaded with the Pope to help source another heart for her son
Lawyer Francesco Petruzzi outside Monaldi Hospital last week. He has since said a foundation would be set up in the toddler's name
Suspicion mounted that the heart had been transported in dry ice, at -80C, which would have significantly damaged the tissue, rather than regular ice.
Petruzzi has said the organ arrived 'burned by frostbite' after being transported over 490 miles from Bolzano to Naples.
It was also reported to have been packed in an ordinary plastic box without a thermostat to alert the medical team to its temperature.
After Domenico had to be hooked up to life support, his mother, Patrizia Mercolino, made an agonising plea to the Pope to help find him a new heart.
She told Italian TV: 'My life is now dominated by pain and the desire to have my baby back home. I appeal to the Pope to help find a new heart for my son. That's all I want.'
Ms Mercolino also implored her lawyer to contact hospitals across Europe in search of a second heart.
On Wednesday, a panel of paediatric specialists concluded Domenico's condition was 'not compatible' with another transplant.
Doctors had warned prolonged use of the life support system might have compromised his lungs, liver and kidneys.
Domenico's donor heart was transported to Monaldi Hospital (pictured) in -80C dry ice, it is suspected
Ms Mercolino had been holding out hope that doctors were wrong, and her son still stood a chance if a new heart could be sourced
Tragically, their prognosis was proven correct, and Domenico lost his battle on Saturday.
The grieving mother has not spoken out since the news of Domenico's death, but her lawyer said the foundation would be for 'all children who cannot have a transplant and to help all victims of malpractice and medical negligence'.
Italian Prime Minister Giorgia Meloni said the 'whole of Italy mourns the loss of little Domenico, a warrior who will never be forgotten'.
She wrote on X: 'On behalf of myself and the government, I offer my sincerest condolences and deepest sympathy to his mother Patrizia, his father Antonio and all his loved ones.
'I am certain that the competent authorities will shed full light on this terrible incident.'
Italy's Health Minister Orazio Schillaci said earlier this week that 'we must absolutely clarify what happened'.
He said: 'We owe it to the child, to the family, but also to all Italians.
'We have an excellent national health service, which has been able to handle and almost always resolve complex situations. So, I believe citizens should not lose faith.'