The agency wrote Abiomed up for failing to report problems with the heart pump and selling its Impella Connect System software and hardware without FDA authorization. The FDA issued the letter in September after inspecting Abiomed’s facility in Danvers, Massachusetts in March and April.
“We are working closely with the FDA to fully resolve the observations as quickly as possible,” Abiomed said in an emailed statement. “As we continue to integrate into Johnson & Johnson MedTech, we are implementing quality system process improvements related to the observations, and many of these corrective actions are already in process.”
“We are dedicated to the mission of providing safe and effective life-supporting heart pump technology to patients worldwide, and Impella heart pumps remain on the market and available for patients in need,” the company continued.
The Impella RP Flex with SmartAssist system is designed for patients with acute right heart failure after left ventricular assist device implantation. The device can be used for up to two weeks after placement via the internal jugular vein. The device supports the right chamber of the heart by pumping blood into the pulmonary artery.
Abiomed recalled at least 466 Impella 5.5 with SmartAssist devices after receiving complaints of purge fluid leaking from the purge sidearm of the pump. The company also recalled devices for potential contact with transcatheter aortic valve replacement (TAVR) implants.
FDA alleges violations in Abiomed warning letter
The FDA said Abiomed failed to identify actions needed to address problems with the Impelle heart pumps and failed to conduct health hazard evaluations or issue formal recall actions for the devices based on the health risks.
Abiomed also failed to verify or validate its corrective and preventative action (CAPA) to make sure that the fixes work and are safe, the agency said. In one case, Abiomet removed a burr on a rotor pump without verifying the process didn’t adversely affect the device. (The implement or process used to remove the burr was redacted in the public version of the warning letter.) In another situation, Abiomed updated software without validating its effectiveness, the FDA said.
In at least five cases, Abiomed failed to file a medical device report (MDR) for broken pumps within the required 30 days, the FDA said. The FDA said the company failed to file reports within 30 days of learning that its device may have caused or contributed to a death or serious injury, or that a known malfunction could cause that level of harm if it happened again.
The FDA also said that Abiomed initiated a medical device correction to reduce a health risk through technical bulletins and updates as far back as March 2016 without notifying the agency.
“The systemic failure to file reports of correction and removal when medical device corrections are made has not been addressed,” the FDA said in its warning letter.
The FDA also said Abiomed should have obtained premarket authorization for its Impella Connect System, which provides remote monitoring for pump performance and alarms.
Abiomed said in a response to the FDA that the system only provided non-device clinical decision support software functions and should not be regulated as a device, but the FDA disagreed, saying the system provides “patient-specific medical information to detect a life-threatening condition and generate time-critical alarms intended to notify a healthcare provider.”
The FDA directed Abiomed to submit the system for review.
The full warning letter (with redactions) is available at the FDA’s website.
