Understanding the Impella Device and Its Potential Dangers

The Impella is a small, minimally invasive heart pump designed to assist patients with heart conditions. Particularly during high-risk procedures like angioplasties or in cases of severe heart failure.

The device is manufactured by Abiomed. It helps the heart pump blood when it is unable to do so effectively on its own. While the Impella has provided lifesaving support to many, it is not without risks. As more patients receive this device, reports of severe complications have surfaced, leading to concerns about its safety.

If you or a loved one has been implanted with the Impella device, it’s important to understand the potential dangers and the legal options available for seeking compensation if complications arise.

What is the Impella Device?

The Impella is a percutaneous ventricular assist device (pVAD) that is inserted through a catheter in the femoral artery or directly into the heart. Once positioned, it helps pump blood from the left ventricle into the aorta, reducing the workload on the heart. This is particularly useful for patients undergoing high-risk cardiac procedures or those in cardiogenic shock, where the heart is too weak to maintain proper blood circulation.

Potential Dangers of the Impella Device

While the device has been a breakthrough in cardiovascular treatment, several risks have been associated with its use. Complications can range from minor to life-threatening, and in some cases, patients may require additional surgeries or medical interventions due to device-related injuries.

Below are some of the most common risks associated with the Impella device:

Vascular Injury

The insertion of the Impella device through the femoral artery can lead to damage of blood vessels, including arterial tears, bleeding, and hematoma formation. Vascular injury can result in severe complications requiring immediate medical attention or additional surgeries.

Strokes

The device can increase the risk of blood clots forming, which may travel to the brain, causing a stroke. Patients who experience neurological symptoms after Impella implantation should seek urgent medical care.

Bleeding

The device can cause significant bleeding at the site of insertion, within the heart, or elsewhere in the body. The need for anticoagulants during Impella use further increases the risk of bleeding complications.

Device Malfunction

Like any medical device, the Impella can malfunction. A malfunction can result in inadequate blood circulation, leading to further heart complications, organ failure, or death.

Infection

Anytime a foreign object is introduced into the body, there is a risk of infection. In some cases, patients have developed severe infections following the device implantation, leading to further health deterioration.

Cardiac Injury

In certain situations, the Impella device may cause damage to the heart itself. This can include perforation of the heart muscle, damage to the valves, or disruption of blood flow within the heart chambers.

Renal Failure

Some patients have experienced kidney failure after Impella implantation, possibly due to reduced blood flow to the kidneys or complications from anticoagulant use.

FDA Warnings and Adverse Event Reports

In recent years, the FDA has received increasing numbers of adverse event reports related to the Impella device. These reports include incidents of stroke, vascular injuries, bleeding, and even death. While the Impella can be a life-saving device when used properly, these risks highlight the importance of careful monitoring and risk assessment when considering its use.

The FDA has issued safety communications urging healthcare providers to be cautious when using the device, particularly in patients with pre-existing conditions that may heighten the risk of complications.

What Should You Do if You’ve Experienced Impella Complications?

If you’ve been implanted with an Impella device and experienced complications, it’s essential to seek medical attention immediately. Even if you’re not currently experiencing issues, understanding the risks and monitoring your health closely can help you catch complications early.

How KBA Attorneys Can Help Impella Patients

If you or a loved one has suffered injuries or complications from the Impella device, you’re not alone. At KBA Attorney, we help patients who have been harmed by defective or dangerous medical devices, including the Impella. Here’s how we can assist you:

1. Free Consultation: Our experienced legal team offers a free consultation to evaluate your case. We can determine whether you have a claim against the manufacturer or healthcare providers involved in your Impella procedure.

2. Comprehensive Case Evaluation: We will thoroughly review your medical records and work with medical experts. This way, we can assess the link between the Impella device and your injuries. This helps us build a strong case on your behalf.

3. Holding Manufacturers Accountable: If the Impella device caused your injuries due to a defect, design flaw, or lack of adequate warnings, we will hold the manufacturer accountable. Our attorneys have extensive experience in product liability cases and know how to take on large medical device companies.

4. Pursuing Compensation: Patients injured by the Impella device may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. We will fight to ensure you receive the compensation you deserve for the harm caused by the device.

5. No Fees Unless We Win: At KBA Attorneys, we operate on a contingency fee basis, which means you won’t pay any fees unless we recover compensation on your behalf.

Protect Your Health and Legal Rights

The Impella device can provide crucial support to many patients with heart conditions. However, it also comes with significant risks. If you’ve experienced complications from the device or another defective medical device, it’s essential to seek medical care and understand your legal rights.

KBA Attorneys is here to help you navigate the legal process and hold those responsible for your injuries accountable. Contact us today for a free consultation and take the first step toward seeking justice.