Abiomed heart pumps linked to 49 deaths

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MONDAY, April 1, 2024 (HealthDay News) — A new warning has been issued about a heart pump whose use could puncture the heart.

The device has already been linked to more than 100 injuries and 49 deaths.

These left-sided Impella heart pumps are manufactured by Abiomed, a subsidiary of Johnson & Johnson MedTech. Abiomed posted the new warning about the devices on the U.S. Food and Drug Administration (FDA) website.

“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices can cause serious injury or death,” the statement says, although it adds that “this recall is a correction, not a disposal of the product”.

The notice informs those implanting Impella devices of the revised instructions for use, which include “carefully positioning the pump catheter during surgical procedures.”

These Impella pumps resemble a long straw inserted into the heart. They are used during high-risk cardiac procedures (for example, during certain types of heart attack), to help maintain adequate blood flow from the heart to the body.

The pump is introduced through the main cardiac vessels and reaches the left ventricle of the heart, the main pumping chamber of the organ.

“Abiomed is recalling its Impella left-sided blood pumps because the pump’s catheter can puncture [cortar] the wall of the left ventricle in the heart,” the company warned in its statement. “During operations, the Impella device could sever the wall of the left ventricle.”

“Use of the affected Impella pumps can cause serious adverse health consequences, including left ventricular perforation or free wall rupture, hypertension, lack of blood flow, and death,” the warning added.

So far, 129 patients have reported serious injuries related to the devices, and 49 patients have died.

The issue was first revealed in a technical bulletin to doctors in October 2021, but the FDA was not informed at the time. An FDA spokesperson told CNN that failing to do so violated the agency’s protocols.

The FDA conducted an inspection of Abiomed’s facilities in September 2023 and issued its own warning letter to the company shortly afterward.

According to Abiomed’s latest advisory, anyone undergoing a procedure with Impella left-sided blood pumps should be aware of the new instructions for use, especially people with heart disease, the elderly, and women.

But Public Citizen, a consumer advocacy group, issued a statement calling for a complete ban on the devices.

Despite dozens of serious injuries and deaths, “the FDA has allowed them to remain in use,” the group said. “In addition, there are serious and continuing concerns about whether there are clinically significant survival benefits that outweigh the risks of these left ventricular assist devices.”

Dr. Robert Steinbrook heads Public Citizen’s Health Research Group.

“Given the continued safety concerns about Impella left ventricular assist devices and this new recall, it is woefully inadequate to review an instruction manual and tell cardiologists to be more careful,” Steinbrook said in a statement. “The use of these left ventricular assist devices must be stopped.”

“Better treatments are urgently needed,” Steinbrook added, and “in the future, these devices should only be used in patients enrolled in a randomized, controlled trial comparing the devices to medical management.” [de fármacos]”.

More information

Learn more about heart attacks and their treatment at the Cleveland Clinic.

SOURCES: Abiomed, statement, March 21, 2024, and technical bulletin, October 2021; US Food and Drug Administration, warning letter, October 10, 2023; Public Citizen, statement, March 29, 2024; cnn