FDA Warns About Widely Used Heart Pumps Linked to Deaths and Serious Injuries

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The U.S. Food and Drug Administration issued a warning for commonly used heart pumps that may cause damage to the heart.

The Impella pumps manufactured by Abiomed have been associated with 129 serious injuries and 49 deaths, according to the FDA.

The Role of Impella Pump

The Impella left-sided blood pump provides short-term support to assist the heart chambers in pumping blood during high-risk surgeries involving catheters. It is used in cases where a patient experiences cardiogenic shock within 48 hours of a severe heart attack, open-heart surgery, or due to cardiomyopathy.

The pump’s function is to reduce the workload on the heart’s ventricles, allowing the heart to recover.

However, the FDA has noted potential serious health consequences associated with the pump itself. These issues include perforation of the left ventricle wall, free wall rupture, hypertension, decreased blood flow, and even death.

After an inspection by the FDA and a warning letter to Abiomed from September 2023, the company issued warnings to customers, surgeons, and medical professionals in December, urging them to adhere to new and revised warnings, including instructions for placement during surgery.

Abiomed’s Recall Problems Continue

The current warning affects six models of Impella pumps and is the latest in a series for Abiomed.

Since 2021, over 66,000 devices have been recalled in the U.S. alone. In June 2023, the company recalled certain Impella RP Flex pumps due to reports of higher-than-expected rates of blood clots.

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Abiomed cautioned about potential interactions between the Impella heart pump and transcatheter aortic valve replacement stents, citing 30 complaints, including 26 injuries and four deaths related to the June recall, according to an FDA announcement.
In April 2023, an additional recall was issued due to a higher rate of purge leaks in the Impella 5.5 pump with Smart Assist.

Previous investigations

Prior to these issues, the FDA investigated Abiomed’s manufacturing facility and issued numerous violations to the company.

These violations included a lack of an approved application for premarket approval for their Impella Connect System. The Impella Connect System is part of the pump system that provides temporary ventricular support to assist in pumping blood during critical care.
Other violations encompassed inadequate facilities for storage that did not conform to the FDA’s regulations for quality system management, a burr on a rotor pump, a systemic software issue in many of the Impella pumps, and failure to report adverse events to the FDA within the required time frame.

For instance, in December 2020, a patient’s pump stopped for five minutes and could not be restarted because the purge side arm of the pump broke. Abiomed did not report this malfunction to the FDA within the 30-day requirement based on the company’s awareness of the issue.

The Impella RP System received premarket approval from the FDA in September 2017. Premarket clinical studies showed that 73.3 percent of patients survived 30 days after the device was implanted and were able to proceed to the next phase of long-term therapy, including heart transplant or implantation of a surgical right ventricular assist device, which is the main purpose of receiving the heart pump.

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