The maker of the first self-contained artificial heart has sent three executives to a Kentucky hospital to investigate the first death attributed to a malfunction in one of the devices.
Don Graham died Sunday, about five months after becoming the 13th patient to receive the life-extending heart. The death was the result of an unspecified malfunction in the device, AbioMed spokeswoman Andrea tenBroek said.
A doctor who sits on an independent advisory panel overseeing a clinical trial of the AbioCor heart suggested Tuesday that the death may justify holding off on plans to implant the device into a final patient in the nearly completed trial.
But Dr. Valluvan Jeevanandam said the next step depends on what experts from AbioMed and Jewish Hospital in Louisville find out about Graham’s death and the malfunction. The company hopes to begin marketing the heart on a limited basis next year.
“If there is an identifiable problem with the device, and if this is a manufacturing defect or a particular type of wear involving this device that we can repair, perhaps they should wait until they repair it before they implant it again,” said Jeevanandam, chief of cardiac surgery at the University of Chicago Hospitals.
The AbioCor, under development for 22 years, is a softball-sized, implantable pump powered by batteries. Unlike earlier mechanical hearts, the AbioCor has no wires or tubes sticking through the skin and is not attached to machinery outside the body.
The device has been able to extend for as long as 17 months the lives of patients at high risk of death from heart failure.
The deaths of 12 patients in the more than 3-year-old trial have been attributed to natural causes related to their illnesses.
But Graham’s death was unexpected, tenBroek said. He had recently been well enough to entertain friends and family at a birthday party at the hospital and to take trips outside the building.
The trial’s 14th patient, who received the AbioCor about three weeks after Graham, remains in intensive care at Jewish Hospital and is the lone survivor with the device.
FDA spokeswoman Sharon Snider declined to comment Tuesday on Graham’s death, citing agency policy against publicly discussing ongoing clinical trials.
