Increased Mortality Rates for the Abiomed Impella RP

February 19, 2019
KBA Attorneys
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The KBA Impella attorney continues focusing on the Impella heart pump, including the Impella RP. Abiomed designed the Impella RP System to assist patients undergoing open chest surgery to maintain stable heart function. Patients treated using the Abiomed Impella RP System may experience a higher mortality rate than previous rates per clinical studies. This data is a result of the FDA evaluating a recent interim post-approval study (PAS).

We will fight for justice for your family if they died from an Impella device. If you are wondering what happened with respect to the Impella device, stay tuned to learn more on our page. Also search for Impella on the site for comprehensive information covering the various iterations of the Impella recall.

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Abiomed Impella RP Linked to Increased Mortality Rates?

The manufacturer designed the Abiomed Impella RP system to support patients experiencing right heart failure. Some allege it is linked to higher-than-expected mortality rates. Patients and their families may be unaware of the serious risks, including device malfunctions, blood clot formation, and fatal complications.

If you or a loved one suffered serious Impella complications—or if you lost a family member due to Impella RP failure—you may be entitled to compensation through a defective medical device lawsuit. Our experienced medical device attorneys are investigating claims related to the dangerous side effects and high fatality rates of this system.

These are complex cases. Obviously anyone using Impella likely had pre-existing conditions. They can make proving the Impella implant was the culprit very difficult. Our analysis starts with the medical records.

If you or a loved one suffered severe complications or death due to the Abiomed Impella RP System, you may have legal options. Call us today at 855-KBA-LAWS (522-5297) for a FREE consultation or fill out our online form to find out if you qualify for a lawsuit. No fees unless we obtain a financial recovery for you, and then we recoup fees and expenses.

Frequently Asked Questions about the Impella RP

1. What are the risks of the Abiomed Impella RP System?

The Abiomed Impella RP System is a medical device. Its makers designed it to provide temporary right-sided heart support for patients with right heart failure. However, some report and allege serious risks including:

Device malfunction or failure, leading to inadequate blood flow
Blood clot formation (thrombosis), increasing stroke risk
Internal bleeding or organ damage
Infections caused by the implantation process
Fatal complications, with some reports indicating higher-than-expected mortality rates

If you or a loved one experienced complications, you may have legal options.

2. Why is the Impella RP System allegedly causing higher mortality rates?

According to FDA reports and to studies, the Abiomed Impella RP System may be associated with increased mortality rates. This may be particularly true in patients who do not meet the exact FDA-approved usage criteria. The post-market data suggests that:

Patients who do not meet the strict inclusion criteria are at higher risk of death
Some devices may fail to deliver adequate blood flow, leading to organ failure
The system’s effectiveness declines over time, resulting in fatal complications

3. Can I file a lawsuit if a loved one died due to Impella RP failure?

Yes. If an Impella RP injured you, you could be eligible for compensation. If a loved one passed away due to complications the Abiomed Impella RP System caused, you may be able to file a wrongful death lawsuit. If an Impella RP injured you, you could be eligible for compensation for:

Funeral and burial costs
Medical expenses related to the device failure
Pain and suffering endured by the victim before passing
Loss of financial support (if the deceased was a provider)
Punitive damages (if the manufacturer is found to have been negligent)

An experienced defective medical device lawyer can help determine if you qualify for a claim.

4. Has the FDA issued a recall for the Impella RP System?

Yes, there are a few FDA notices concerning Impella RP System related recalls. The Agency issued safety communications and warnings about its risks, particularly the higher-than-expected mortality rates. Some key updates include:

FDA safety alert warning about Impella RP failure rates
Increased post-market surveillance due to concerns over patient outcomes
Legal investigations into whether Abiomed failed to disclose known risks

Don’t take our word for it, see for yourself. Here are some FDA Impella recall details:

If you or a loved one experienced serious harm or death due to this device, legal action may be an option.

Benefits Outweigh Risks?

Do the benefits outweigh the risks for the Impella device? We have a concern about the high mortality rate identified in the interim PAS noted above in the FDA notice. Some believe the Impella RP system is best for patients appropriately approved. In this case, the benefits presented by the device may significantly outweigh its risks. For others, the risks may outweigh the benefits. Trained doctors must make that clinical decision.

After an injury, an Impella attorney or wrongful death attorney would retain an expert to evaluate the patient’s clinical history to determine if, more likely than not, the Impella device caused the patient’s death. These are difficult cases because of the patients’ medical history. They require skilled medical device lawyers and experts.

History

Following is some history about the Impella device. FDA approved the Impella RP System September 20, 2017, per our research in the applicable FDA database. The approval order required post-approval studies.

Doctors used it to help patients who need temporary emergency support of their right ventricular function. Surgeons implanted the device via peripheral access and placed centrally. Patients could remain in the hospital for up to 14 days after using the device. More precisely, “The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2 , who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.”

Impella RP Adverse Events

Within the Impella heart device’s labeling, the company disclosed specific adverse events. Specifically, Impella presents the following potential adverse events or complications:

Impella adverse events/Impella complications per PMA labeling

Clinical Studies

Strict exclusion and inclusion criteria were used in premarket clinical studies. During this time, approximately 44 of 60 patients survived. This means 73.3 percent of patients survived for 30 days after their hospital discharge. It also includes those who survived at the start of the next term of therapy. These are individuals who had the implantation of the surgical right ventricular assist device (RVAD) as well as those who had a heart transplant.

Additional Analyses

The high mortality rate seen in the PAS prompted the FDA to require additional analysis from Abiomed. Results show premarket clinical patients have usually been in cardiogenic shock for over 48 hours when the device was used. Some were treated with an intra-aortic balloon pump while others were treated using other in-hospital cardiac arrest procedures. The FDA’s evaluation is ongoing. The root cause of the high mortality rate remains unknown.

Data about the Impella Heart Pump

FDA should continue to review data from the continuing PAS. Abiomed will likely continue to work with the FDA to make certain the PAS interim results continue. New or additional information should be publicly available.

It seems possible for this device to hurt individuals. Legal professionals at KBA Attorneys have experience with the FDA and medical device manufacturers. We know how to evaluate a potential case and what is the best way to proceed. Fill out our online application by contacting KBA Attorneys today for a case evaluation.