California Man Dies After Apparent Failure of Artificial Heart Compressor

“It is unfortunate, but that particular patient was on our device for over 500 days, and we extended the life of that patient, who was extremely ill and near death at the time of his artificial heart implant,” Garippa said.

Cedars-Sinai officials said they notified the FDA, SynCardia and the California Department of Public Health, which is also conducting an investigation.

The FDA has received several other complaints regarding SynCardia compressors in the last few months, according to the agency’s online database of adverse events. In one, a patient with a SynCardia artificial heart and portable driver reported collapsing and being rushed to the hospital.

“Failure of this can lead to my death,” the patient wrote in September. “Something needs to be done to improve quality of these devices.”

The public database does not contain the names of hospitals or patients.

Garippa said that in the past six months, patients have had to go back into hospitals about four different times because the alarms on their compressors were going off. That includes two occasions in which the patient either dropped or kicked the device and it later failed, Garippa said.

“There are all sorts of things that can happen,” Garippa said. “We are helping people live as full and as long a life as possible and occasionally things go wrong. The alternative used to be staying in the hospital tethered to a machine.”

In August, a San Diego man with the SynCardia artificial heart and the portable compressor died at a hospital in Poway after his driver stopped working, according to Victor Pretorius, surgical director of heart transplantation at UC San Diego Health. The man’s artificial heart was implanted at Cedars-Sinai, but he was being cared for at UCSD. It is unclear what may have caused the death.

Cedars-Sinai officials declined to discuss the case, citing patient confidentiality. A spokeswoman said the Oct. 2 death is the only one the hospital has reported in which the patient was suspected to have died from the possible failure of a SynCardia driver.

Garippa said he believes the San Diego man’s device may have alarmed after he collapsed onto the compressor and that his young son didn’t know how to switch to a backup.

SynCardia’s Total Artificial Heart is for people whose own hearts can’t pump enough blood to keep them alive. The device is implanted in the patient and replaces all four heart valves as well as the right and left ventricles. It is only used in the most severe cases of biventricular heart failure, and the patients are often very sick when they receive the hearts.

The one-year survival rate for people who had the artificial hearts implanted between 2006 and 2015 was 56 percent, according to data from the Interagency Registry for Mechanically Assisted Circulatory Support, which collects clinical data on devices.

If patients with the artificial heart are in the hospital, they are typically connected to one of two larger drivers, which come in two sizes, 40 and 400 pounds. Those who are clinically stable and have a full-time caregiver may be able to go home with the Freedom portable driver, which weighs less than 14 pounds.

Cedars-Sinai implants the most artificial hearts in the world, according to SynCardia. At the time of Trudell’s death, Cedars-Sinai had five other patients on the Freedom driver, according to the hospital. Those who were stable enough were switched to a larger, non-portable driver at the hospital, and the others are in intensive care for close monitoring, hospital officials said.