Parker Waichman LLP is investigating potential lawsuits involving the HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller. The HeartMate II LVAS is a device that helps pump blood throughout the body when the heart is too weak to do it on its own. The HeartMate II LVAS pump comes with a controller and patients are also given a back-up controller. In 2017, the HeartMate II LVAS Pocket System Controller was recalled because 26 patients died and 19 were injured while exchanging their backup controllers. The deaths occurred when patients tried to exchange controllers outside of the hospital. The U.S. Food and Drug Administration (FDA) gave its most serious Class I designation on the recall.
If you or someone you know is interested in filing a lawsuit over the HeartMate II LVAS Pocket System Controller recall, please contact one of our experienced product liability attorneys today. Parker Waichman LLP offers free, no-obligation case evaluations.
26 Patients Die, 19 Injured After Exchanging Controller
The HeartMate II LVAS is a blood pump that helps circulate blood throughout the body when the heart is too weak to pump blood on its own. The pump is connected to the Pocket System Controller through a lead, also referred to as a driveline, that is implanted under the skin. The controller may be used both inside a hospital and at home. Each patient also receives a back-up system controller in case the device malfunctions or an alarm sounds. Patients are given instructions on how to switch controllers.
Sometimes, patients need to change their back-up controller. The FDA notes that, “The change should be done quickly and in the hospital, because it can present a significant challenge to patients that (sic) are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death.” In 2017, a recall was issued because patients became injured and died while trying to exchange controllers on their own.
According to an FDA recall notice, Abbott-Thoratec informed customers about the issue in a March 29, 2017 “Urgent Medical Device Correction” letter.
In May 2017, the FDA labeled the recall as Class I, the most-serious recall status. Class I recalls indicate that exposure to the recalled device presents a reasonable risk of serious injury or death.
The recall affects model/item numbers: 105109, 106015, 106762, and 107801. According to the recall notice, 28,882 units are affected in the United States. The recalled products were manufactured between July 2012 and December 2016 and distributed between July 2012 and March 2017.
According to the recall alert, 70 incident reports were submitted to Abbott-Thoratec regarding the issue. These reports include 19 injuries and 26 deaths. Fatalities all occurred when patients exchanged controllers outside of the hospital. Abbott says it is updating software and hardware in response. “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,” the alert indicates.
In its letters to customers, Abbott-Thoratec disclosed the issue and provided recommendations. Among other things, the company wrote that new patients will receive upgraded hardware and software. This includes a fully upgraded system controller with new yellow alignment markings and a new lead/driveline.
Existing patients will receive updated device software and alarm guides for both primary and back-up controllers. The device maker notes that “If existing patients need their controller replaced (if damaged or an old model controller), Abbott-Thoratec will replace the controller at no cost, but the patient’s implanted drive line will not be changed to have matching yellow markings.”
According to the letter, Abbott-Thoratec will inform all affected health care providers of the issue. The company indicates that it will coordinate office visits in which Abbott representatives will install updates on primary and backup System Controllers and explain the updates. The recall announcement notes that, “The alarm notification system has been updated to remove advisory alerts on the patient’s System Controller. 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.”
Patients are advised to contact their VAD coordinator if an alarm appears on their System Controllers. The exchanges must be performed by their VAD Coordinators in the hospital.
“Despite past efforts to improve training and education, we are aware of patients experiencing a very low level of adverse events as a result of unnecessary patient controller exchanges,” an Abbott spokesman said to the Star Tribune. “We are updating its alert guides, conducting a software upgrade and adding controller alignment markings for the HeartMate II System Controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations.”
Class I Recall Issued for HeartMate II LVAS Due to Controller Issue
Parker Waichman notes that this is not the first time a Class I recall was issued for the HeartMate II LVAS Pocket System Controller. The device was previously recalled in March 2014 because patients had trouble switching from the older EPC System controller to the newer Pocket System Controller.
The recall affected the following catalog numbers:
- 106015 and 106016: HeartMate II LVAS Implant Kit with Pocket Controller
- 106762 and 106017: HeartMate II LVAS Pocket System Controller
- 107801: HeartMate II LVAD Pump and Pocket Controller Kit
- 105109: Pocket System Controller removed from packaging
According to a recall alert posted on the FDA website, Thoratec received five reports of serious injury and four reports of death related to the controller issue. In all cases, patients were switching from the EPC System controller to the Pocket System Controller; however, patients were not properly trained on how to connect the new controller. The pump connected to the Pocket System Controller is not the same as when the pump is connected to the EPC System Controller.
The affected devices were distributed between August 2012 and June 2014.
“All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller,” the recall alert indicated. “The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected. If the controller is not properly connected, the device cannot function. The use of this product may cause serious adverse health consequences, including death.”
Thoratec sent an “Urgent Medical Device Correction” letter to customers affected by the recall. The letter included actions to be taken; doctors were instructed to review the updated labeling and training materials. This material should be reviewed with clinical personnel, Thoratec indicated.
The letter also instructs patients and caregivers to be retrained if they are using the Pocket System Controller.
Filing an Abbott-Thoratec HeartMate II LVAS Lawsuit
If you or someone you know experienced injury or death related to the HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller recall, please contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
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