Abbott-Thoratec’s HeartMate II Left Ventricle Assist (LVAS) Pocket System Controller has been the center of multiple recalls since the device injured thousands of people.
The Michael Brady Lynch Firm offers case evaluations at no cost or obligation to you. You should call us today at (877) 513-9517 or contact us online to learn more about what we can do to help you and your family.
About HeartMate II LVAS
The Abbott-Thoratec’s HeartMate II LVAS is a heart pump device to help patients awaiting heart transplants. The $100,000 system enables blood delivery from the dysfunctional left ventricle of the patient’s heart to the body. It helps generate blood flows up to 10 liters per minute. Doctors implant the device in the abdomen, and a connector brings blood from the pump to the aorta.
In an earlier version of the device, the manufacturer attached the bend relief and outflow graft to the pump. However, early last year, Abbott-Thoratec released the new version. It now comes with a detachable release to help surgeons to more easily remove air from the graft. Currently, HeartMate is the only product on the market for heart-failure patients.
Multiple Class I Recalls
Thousands of people depend on this system to save their lives. Unfortunately, it can lead to a multitude of injuries and complications. When the FDA issues a Class I recall, this means a medical device is defective, and it could lead to serious harm or death. A Class I Recall is the most severe.
2015 Class I Recall
The first Class I recall Abbott-Thoratec’s HeartMate II LVAS received was two years ago. Regulators were concerned about a blood flow problem involving a defect in the device. The device’s bend relief can detach from its intended position. This can cause the graft to kink or deform, which leads to decreased blood flow causing pump thrombosis.
Then, the FDA received reports and information from a variety of sources indicating an increase in the rate of pump thrombosis. Their information showed an increase in this side effect even earlier than in the initial clinical trials. These trials were instrumental in 2008 and 2010 FDA approval. For example, two analyses in the scientific literature reported the confirmed pump thrombosis rate as high as 8.4% of implanted devices at 3 months (Starling et al, 2013) and 6% of implanted devices at 6 months (Kirklin et al, 2014). This is compared to 1.6% of implanted devices at one year during the BTT clinical trial and 3.8% of implanted devices at 2 years during the DT clinical trial.
Pump thrombosis is a serious complication that can require a repeat surgery to replace the pump or can lead to death. The FDA received 30 reports of the heart pump not being connected correctly. In five cases, patients needed additional surgery, and one patient died.
The FDA acknowledged the severity of increased pump thrombosis, however, decided to keep the device on the market. Instead, they asked for new device instructions stating what actions to take to ensure the bend relief is fully engaged with the sealed outflow graft when implanted. A warning will also be included to caution doctors about the bend possibility.
2017 Class I Recall
Recently, the FDA issued another Class I Recall. This time it involved the HeartMate II LVAS’s backup system. Patients may sometimes need to change to their backup system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death. Abbott-Thoratec has received 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths.
To address this issue, Abbott-Thoratec is providing all HeartMate II LVAS with Pocket Controller users with new software and hardware updates to assist patients in successfully changing their pocket controller.
The model numbers affected are:
Furthermore, the manufacturing dates in question are between July 2012 and December 2016 and were on the market between July 2012 and March 2017. There are an estimated almost 30,000 devices involved in the recall.
If Your Device was Recalled
On March 29, 2017, Abbott-Thoratec sent an “Urgent Medical Device Correction” letter to affected customers.
The letter identified the following actions:
- New HeartMate II LVAS Pocket System Controller patients will receive upgraded hardware and software (to include a fully upgraded system controller with new yellow alignment markings and new lead/driveline).
- Existing HeartMate II LVAS Pocket System Controller patients will receive updated device software and alarm guides for both their primary and backup controllers.
- If existing patients need their controller replaced (if damaged or an old model controller), Abbott-Thoratec will replace the controller at no cost. However, the patient’s implanted driveline will not be changed to have matching yellow markings.
- In addition, Abbott-Thoratec will contact all affected health care providers to coordinate office visits. Each office visit should include:
- Software updates on the primary and backup devices.
- Explanation of the latest software update to the patient and caregiver(s).
- The alarm notification system has been updated to remove advisory alerts on the patient’s device. These are noncritical alerts that will be seen by the physician on the System Monitor when the patient goes in for the next routine appointment.
- Also, there is a reminder to patients to contact their VAD coordinator in the event an alarm appears on their device.
HeartMate II LVAS Injuries
Thousands of people depend on this system to save their lives. Unfortunately, it can lead to a multitude of injuries and complications. Patients may sometimes need to change to their backup system controller during the course of ventricular assist therapy. A hospital should perform the change quickly. This is because of challenges to elderly patients or the untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death.
As a result, Abbott-Thoratec has received 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths.
Therefore, to address this issue Abbott-Thoratec is providing all HeartMate II LVAS with Pocket Controller users with new software and hardware updates to assist patients in successfully changing their pocket controller in emergency situations.
This isn’t the first issue. The FDA issued a previous recall after nearly 30 reports of the heart pump not being connected correctly. In five cases, patients needed additional surgery, and one patient died.
Speak to an Attorney Today
Therefore, if Abbott-Thoratec’s HeartMate II Left Ventricle Assist System injured you, you need a law firm with decades of experience going against large corporations. The Michael Brady Lynch Firm will take whatever legal measures are necessary when fighting for your rights to damages.
How We Can Help
When you experience side effects from a dangerous device, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a drug company in manufacturing and selling the device is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed complications after using Abbott-Thoratec’s HeartMate II Left Ventricle Assist System, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.
FDA Recalls around 30,000 Abbott-Thoratec’s HeartMate II LVAS Devices