Editor's note: This story has been updated from the original story to include comments from Abiomed.
A report published through FDA's medical product safety network (MedSun) database describes two issues that involve Abiomed's Impella heart pumps. However, the company told MD+DI that the information in the MedSun report is inaccurate.
According to the report, which is located here on FDA's website, one Impella pump reportedly had an unknown "material" inside the pump, causing it to have flows "less than expected," and another pump's housing/outlet cage and impeller were somehow crushed and the device did not start.
Abiomed claims that the pumps did not malfunction.
"The first pump worked exactly as it was supposed to – a clot was detected in the patient’s bloodstream and a safety mechanism triggered, shutting down the pump, so the clot did not go to the patient’s brain. The second pump was damaged during the insertion process," said Tom Langford, director of communications and public relations at Abiomed.
MedSun is an adverse event reporting program launched in 2002 by FDA's Center for Devices and Radiological Health (CDRH). The way the program works is participants use an Internet-based system that is designed to serve as an easy and secure way to report adverse medical device events. The agency says the primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices. Once a problem is identified, MedSun researchers work with each clinical facility's representatives to clarify and understand the problem, according to FDA.
The MedSun report in question noted that the devices used in the reported case "may have caused or contributed to death" although no further details were disclosed. Langford said neither incident contributed to any patient's death. He said Abiomed tracks and reviews "almost every case" as part of the company's commitment to continuously improve patient outcomes.
"The review determined the use of Impella was unrelated to the final outcome of the case, in which the patient sadly passed away after an IABP [intra-aortic balloon pump] was used," Langford said.
He also noted that medical device companies don't make reports into MedSun, and that information entered into the database "is not checked for accuracy or verified before it is posted."
MD+DI has reached out to FDA for comment and this story will be updated if and when the agency responds.
Abiomed's Impella heart pumps are used to treat heart-attack or cardiomyopathy patients in cardiogenic shock and are designed to enable native heart recovery, allowing patients to return home with their own heart.
The Danvers, MA-based company has been busy the past couple years and was among MD+DI's 2017 Company of the Year finalists. In April Abiomed received FDA approval for its Impella CP heart pump with SmartAssist using an optical sensor. The sensor is one component of the SmartAssist technology, which also includes a software update enabling informational displays of left ventricular pressure, end-diastolic pressure, and cardiac power output data on the Impella Console.