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Impella Heart Pump Lawsuit 2024 Update: Death Risk Revealed?

The U.S. Food and Drug Administration (FDA) is warning that left-sided Impella heart pumps made by Johnson & Johnson MedTech’s Abiomed have been linked to over 100 serious injuries, including nearly 50 deaths. The new FDA warning alerts customers about a risk of heart perforation “due to operator handling.”
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What is the Impella Heart Pump?

According to a 2022 research by the Medical News, the Impella Heart Pump is marketed as a minimally invasive solution that healthcare professionals can deploy without resorting to heart surgery [1]. The pump is designed to maintain optimal blood flow in patients suffering from coronary artery disease (CAD), recuperating from cardiogenic shock, or awaiting heart transplantation.

Doctors call the Impella a percutaneous ventricular assist device. It keeps the heart working in two situations: during percutaneous coronary interventions (PCI) and following cardiogenic shock. Cardiogenic shock is a life threatening event when the heart cannot pump enough blood to the body.

What’s the Problem?

According to an FDA warning published on March 21, 2024 [2], a slew of recent studies have raised concerns regarding the safety of Impella heart devices, indicating an elevated risk of mortality among patients with unstable medical conditions.

Despite these troubling revelations, Abiomed, the manufacturer of the Impella device, has invested substantial resources in promoting its product, doling out generous consulting payments to cardiologists and grants to hospitals.

Since Abiomed’s initial acknowledgment of Impella Heart Pump complications in October 2021, the FDA has received an additional 21 reports detailing heart-wall tears associated with patient fatalities.

This prompted the FDA to issue an alert categorized as the most severe type of action for a product that poses the potential for death or serious injury, falling just short of mandating its removal from the market.

However, the alert still permits the continued use of the device, albeit with a stipulation for an update on the risks outlined in the 243-page instruction manual accompanying the pump.

Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. During operations, the Impella device could cut through the wall of the left ventricle,  FDA said. The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. There have been 129 reported serious injuries, including 49 reports of death.

Presently, there are approximately 66,000 Impella pumps in circulation within the United States, with an additional 26,000 devices deployed across various countries including Australia, Canada, France, and India, among others.

Impella Heart Pump Injuries

  • Heart perforation
  • Left ventricle perforation
  • Free wall rupture
  • Hypertension
  • Lack of blood flow
  • Death
  • And more

FDA Issues Highest-Level Alert for Heart Pump Linked to 49 Deaths: TODAY News Video

Status of Abiomed Impella Heart Pump Recalls

The Abiomed Impella heart pump recall, categorized as a Class 1 recall, was initiated on June 14, 2023. Class 1 recalls are issued when defective medical devices pose the potential for serious injuries or fatalities. This recall encompasses over 7,895 units of the pump distributed from May 1, 2021, up to the present date.

Recall Timeline for Impella Heart Pump:

  • June 29, 2023: Recall of the Impella RP Flex with SmartAssist, distributed from November 1, 2022, onwards.
  • June 14, 2023: Recall of Abiomed’s Impella left-sided blood pumps, with ongoing lawsuits from affected patients and their families.
  • April 17, 2023: Recall of Impella 5.5 with SmartAssist devices distributed between September 28, 2021, and March 6, 2023.

Abiomed advises healthcare providers against using the specified device in any procedure unless no alternative options are available. In such instances, the company provides guidance on steps to mitigate the risk of the pump causing harm or fatalities.

Per the FDA recall notification’s instructions for customers, the pump is “not being removed from the field and does not need to be returned.”

FDA Says Impella Heart Wall Tears caused by “Operator Handling”

According to the New York Times, the company has attributed incidents of heart-wall tears to “operator handling,” emphasizing the importance of utilizing imaging tools alongside the device to mitigate the risk of puncturing delicate heart tissue [3]. The FDA has highlighted that older adults, women, and individuals with pre-existing heart conditions are particularly vulnerable to such complications.

The pumps are temporary implants, tailored to the right or left heart chamber with different levels of pumping power. They are often used after a patient has had a major heart attack and the heart loses its ability to move blood through the body. The devices tend to be used on very ill patients, many with a mortality risk of about 40 to 50 percent, Dr. Boback Ziaeian stated.

However, if a heart wall is torn by the device, it constitutes a surgical emergency with exceedingly low survival rates, as noted by Dr. Boback Ziaeian, a cardiologist and assistant professor of medicine at the University of California, Los Angeles.

The FDA’s recent alert follows a comprehensive inspection conducted at Abiomed’s Massachusetts headquarters last year, culminating in a warning letter issued in September. During the inspection, regulators uncovered numerous complaints that should have been reported, along with the discovery of a bulletin dated October 2021 addressing the tearing risk.

The bulletin, which Abiomed purportedly published on its website and app, outlined heart-wall perforations as a “rare complication” initially identified in January 2018. According to the FDA spokeswoman, Ms. Harrison, Abiomed was obligated to file a report of correction or removal to the FDA within 10 days of this notice.

Do I Qualify to File an Impella Heart Pump Lawsuit?

Individuals who have suffered severe injuries due to the Abiomed Impella heart pump, as well as those who have lost a loved one or witnessed severe injury caused by the defective device, have the option to pursue legal action through a lawsuit. Seeking guidance from an experienced product liability or wrongful death attorney is crucial to assessing the specifics of your case and determining eligibility.

Key criteria for filing a lawsuit may include:

  • Undergoing heart valve replacement surgery wherein the doctor reported pump failure or damage during the procedure.
  • Suffering from brain damage or another serious injury due to lack of blood flow, or experiencing the loss of a loved one.
  • Undergoing an operation during a heart attack or cardiogenic shock that involved the use of a temporary blood pump.

In wrongful death claims citing product liability, it is essential to demonstrate that the heart pump was defective, whether due to manufacturing issues, design flaws, or insufficient warnings in the instructions.

Moreover, the claim must establish a direct link between the defect and the patient’s death. The primary defect associated with the Abiomed Impella heart pump is a damaged purge sidearm, heightening the risk of purge fluid leakage.

Heart Failure Mortality Statistics

  • OPTIMIZE-HF, IMPACT-HF, EFFECT, and the EuroHeart Failure Survey have demonstrated no significant difference in mortality or rehospitalization between patients with reduced and pEF.
  • OPTIMIZE-HF reported mortality rates of 37.5%, 35.1%, and 35.6% at 1 year for patients with reduced, mid-range, and pEF in patients in the USA.
  • EFFECT demonstrated similar numbers for 1-year mortality for patients with reduced and pEF (25.5% and 22.2%) in the Canadian population.
  • The EuroHeart Failure Survey noted an estimated 1-year mortality rate of 23.6% for acute heart failure and 6.4% for chronic heart failure.
  • The Swedish Heart Failure Registry utilized 12 years of data to compare mortality between patients with reduced and pEF and found no significant difference.
  • One-year all-cause mortality for heart failure patients in Spain was 14% but found that those patients with recent hospitalization faced an increased likelihood (24%)

According to the Annals of Translational Medicine [4].

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