Update: Includes statement from Abiomed
The Impella devices were used in a last-attempt effort to save an elderly patient undergoing open heart surgery, Abiomed CEO Mike Minogue said in a statement sent to MassDevice.com
“This was a very sick elderly patient who had poor heart function. The patient was having trouble coming off a heart and lung machine during open heart surgery. Impella was used as a last resort to try to save the patient,” Minogue wrote in the statement. “We closely track our cases, reviewed this case when it happened, and it was determined Impella was not related to the outcome.”
The first pump detected a clot in the patient’s blood stream and stopped functioning to prevent the clot from entering the patient’s brain, Minogue said in the statement, while the second pump was likely bent during the insertion process.
“We’re saddened to hear of any patient’s death from heart disease, and this only increases our commitment to our mission of recovering hearts and saving lives,” Minogue wrote in the statement.
The Danvers, Mass.-based company initially reported issues with two Impella pumps in a posting to the federal watchdog’s Medsun database last month.
The issues were investigated by engineers who found material in the first pump that reduced flow, and that the pump housing/outlet cage and impeller were crushed in the second.