Impella Pump Heart Perforation Problems Were Not Adequately Disclosed to FDA: Report

FDA recently warned about a serious risk of heart perforations from Impella pumps, due to faulty instructions that may have resulted in more than 100 injuries and nearly 50 deaths

Amid continuing concerns about problems with Impella heart pumps in recent years, it now appears that the device manufacturer may have failed to report a number of malfunction-related deaths and injuries to the U.S. Food and Drug Administration (FDA), including heart perforations and other severe complications experienced by users.

The Abiomed Impella pump is a cardiac support system, which is designed to assist patients with severe heart conditions. Specifically, the pencil-sized Impella blood pumps are inserted into the heart’s left ventricle, through a minimally invasive incision in the femoral artery, and work by drawing blood from the left ventricle and expelling it into the ascending aorta to maintain circulation of oxygen-rich blood throughout the body.

The devices are commonly implanted in individuals undergoing cardiac procedures, or in situations where the heart needs support to maintain adequate blood flow through the body, such as during high-risk percutaneous coronary interventions (PCI) or in the treatment of cardiogenic shock, which occurs when the heart suddenly can’t pump enough blood to meet the body’s needs.

While Abiomed’s Impella pumps have been widely adopted by cardiologists and hospitals for treatment of patients with severe heart conditions since 2008, the devices have been subject to multiple FDA recalls and warnings in recent years, and there is now new evidence that suggests the manufacturer may have failed to report a number of fatalities and injuries while updating the safety information for their product.

History of Impella Heart Pump Recalls and Warnings

The Impella Heart Pump has been linked to a series of problems outlined in FDA warnings and recalls in recent years, with one of the first and most notable issued in May 2019, when the FDA highlighted an increased increased mortality rate with Abiomed Impella RP Heart Pumps.

In the Impella pump warning, officials stated that while initial clinical trials reported a 73% survival rate among patients, real-world interim results from 2019 showed only a 28% survival rate among Impella patients transitioning to long-term therapy. The warning indicated that only 12 out of 42 patients enrolled in a post-approval study survived to the 30-day hospital discharge mark.

Issues arose again in June 2023, when Abiomed responded to multiple complaints regarding the Impella 5.5 with Smart Assist pumps potentially leaking purge fluid, which could lead to device failures and adverse patient outcomes. Rather than removing the devices from the market, Abiomed updated the instructions for use (IFU), seeking to mitigate risks associated with treating patients post-TAVR procedure and the potential for the Impella motor housing to damage heart valves.

The FDA subsequently escalated the IFU announcement to an Impella Blood Pump Class I recall, warning that nearly 8,000 Abiomed Impella Left Sided Blood Pumps may suffer motor damage when used in patients who have undergone transcatheter aortic valve replacement (TAVR).

In August 2023, Abiomed initiated another Impella pump catheter recall due to blood clot risks that were not properly addressed in the devices’ instructions for use. This recall was focused on the catheter system’s instructions and labeling inadequacies, following at least 12 reported injuries.

In the most recent regulatory action, the FDA announced a Class I recall for the Impella Left Sided Blood Pump on March 21, following numerous reports of the pump catheters piercing the wall of the left ventricle in the heart, which may cause serious and life-threatening health effects.

Officials indicated the manufacturer was aware of at least 129 reports of serious injuries, including 49 reports of death from Impella pump heart perforations.

The recall included approximately 66,390 Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD models distributed nationwide from October 10, 2021, to October 10, 2023. Roughly 25,000 additional units were sold internationally in countries including Australia, Canada, France, and India.

Abiomed Failed to Report Impella Pump Heart Perforations and Deaths

As the series of Impella heart pump problems continued, Abiomed’s method of addressing heart perforation risks linked to the devices has come under FDA scrutiny after an in-depth review revealed that some potential safety issues were not properly reported.

In an FDA warning letter to Abiomed late last year, the agency identified multiple examples of Abiomed’s failure to submit timely MDR reports, including;

• Patient Deaths: Abiomed failed to report two patient deaths within 30 days of becoming aware of the incidents.
• Malfunctioning Devices: Abiomed failed to report several incidents involving malfunctioning Impella devices that led to serious patient injuries, including a cracked and leaking purge sidearm, a pump stoppage, and hemolysis.

During the FDA inspection, it was discovered that Abiomed had issued a bulletin on its website and app in October 2021, disclosing a risk of heart tearing associated with Impella devices; a complication known to the company since January 2018. Abiomed labeled this risk as a “rare complication.”

The FDA warning letter states that Abiomed was expected to file a formal notice about this issue within 10 days, but chose to communicate it differently, avoiding a direct disclosure of such heart tearing events to the FDA. The manufacturer’s actions have been seen as an attempt to downplay the severity of the issues and avoid a costly market withdrawal of the Impella devices.

In a recent New York Times report published on March 29, 2024, it was revealed that Abiomed was aware of at least 21 additional heart-wall tears with Impella pumps that may have resulted in patient’s deaths since October 2021, when the company first issued the bulletin on its website.

Abiomed Impella Heart Pump Lawsuits

Given the growing evidence regarding deaths and injuries that may have been avoided, lawyers are now investigating potential Impella heart pump perforation lawsuits over potential defective designs and the manufacturer’s apparent failure to warn about problems that may have been known since January 2018, but were not disclosed until several years later.

This delay, and the company’s choice to label the issues as “rare” on its website and app, instead of directly informing the FDA promptly, has potentially kept patients and doctors from making fully informed decisions about the pumps’ safety, which may have directly resulted in additional injuries and deaths.