The company distanced itself from the death, with chief exec Stephanie Piat stating that the artificial heart was not involved and that the last 3 implantations of the device functioned normally, according to Reuters.
The French regulatory body requested further information from Carmat following the death of the patient, who was implanted with the heart at the end of August.
The patient was the 1st of 20 scheduled to receive the hearts in a clinical trial of the devices as the company seeks regulatory approval, according to Reuters. Other patients in the trial are slated to receive their hearts in the coming weeks.
Shares in Carmat have dropped 17.7% this year, with the compay valued at approximately $211.7 million (EU €2 million).
In August, the company launched a pivotal trial of its bioprosthetic artificial heart, hoping to use the data to win CE Mark approval in the European Union.
Carmat’s 1st transplant patient, a 76-year-old man, died in March 2014, 2½ months after his operation. A 2nd patient died in May 2015, 9 months after receiving the transplant. Carmat said his death was due to a technical problem with the controls of the motor. A 3rd patient was fitted with the device in April 2015.
“The 4th patient will undergo surgery once everything has been analyzed and the engineers are able to tell me, ‘Go ahead, we’ve checked everything, everything’s fixed, the new device won’t [encounter] the same issues as the previous ones,’” Dr. Alain Carpentier, who invented the device, said at the time.
Material from Reuters was used in this report