HeartMate II LVAS Pocket System Controller Device May Fail During Backup Controller Exchange
The U.S. Food and Drug Administration (FDA) has announced a recall of the HeartMate II LVAS Pocket System Controller by device maker Abbott. The recall has been deemed a Class I by the agency, which is the most serious recall designation. Should a Class I-recalled device be used, a likelihood of serious injury or death may occur.
When the Abbott Thoratec-HeartMate II OVAS Pocket System controller is used, it is possible that patients may be injured or may die during the Backup Controller Exchange.
The recall specifically involves the HeartMate II Left Ventricular Assist (LVAS) Pocket System Controllers with model/item numbers 105109, 106015, 106762, and 107801. The device manufacturing dates are from July 2012 to December 2016 with distribution dates of July 2012 to March 2017. The devices were recalled in the United States and 28,882 devices were recalled nationwide.
The Pocket System Controller is a medical power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline), which is located under the skin. The controller assists in powering the LVAS system, which is a mechanical device that circulates blood through the body when the heart is too weak to adequately pump blood on its own. The controller is powered either by batteries or connected to a main power supply.
The HeartMate II LVAS Pocket System Controller is meant for use inside or outside of the hospital. Every patient receives a back-up system controller for use in the event of a device alarm or malfunction. Both instructions and training are given on how to switch from one system controller to the other controller.
On occasion, patients may need to change to their backup system controller during the course of ventricular assist therapy. This change must be accomplished rapidly and in the hospital, because the change may present a significant challenge to patients who are elderly and/or untrained. A slow or improper driveline changeover places these patients at risk for serious injury or death.
To date, Abbott-Thoratec has been associated with a total of 70 reports of incidents, which included 19 injuries and 26 deaths. Every death took place when patients attempted to exchange controllers when away from the hospital. To address the issue, Abbott-Thoratec is providing all users of the HeartMate II LVAS with Pocket Controller with new software and hardware updates to assist patients in correctly changing their pocket controller in emergency situations.
The agency indicates that those who may be affected include patients implanted with a HeartMate II LVAS Pocket System Controller and health care providers who are treating patients implanted with a left ventricular heart failure using the HeartMate II LVAS Pocket System Controller.
The defective device attorneys at Parker Waichman LLP have decades of experience in medical device litigation and continue to offer free legal consultations to individuals with questions about filing a defective Abbott-Thoratec HeartMate II OVAS Pocket System Controller medical device lawsuit.
On March 29, 2017, Abbott-Thoratec sent an “Urgent Medical Device Correction” letter to its impacted customers. In its letter, the device maker identified specific actions that have been, and will be, taken. The recall was initiated March 30, 2017 and the agency most recently deemed the recall a Class I:
- New HeartMate II LVAS Pocket System Controller patients will receive upgraded hardware and software (to include a fully upgraded system controller that will include new yellow alignment markings and new lead/driveline) from their ventricular assist device (VAD) coordinator.
- Existing HeartMate II LVAS Pocket System Controller patients will receive updated device software and alarm guides for their primary and back-up controllers.
- Should an existing patient require a controller be replaced due to damage or if the patient is in possession of an old model controller, Abbott-Thoratec will replace the controller at no cost; however, the device maker will not cover the patient’s implanted driveline to have matching yellow markings.
- Abbott-Thoratec indicated that it would contact all impacted health care providers to coordinate office visits, receipt of software updates, and updated labeling. Each office visit should include software updates on both the primary and backup System Controllers and, with support from authorized Abbott representatives, an explanation of the latest software update to be provided to the patient and his or her caregiver(s).
- The alarm notification system was updated to remove advisory alerts on the patient’s System Controller—advisory alerts are noncritical alerts that a physician sees on the System Monitor when the patient is seen for his or her next routine appointment—; to include a patient reminder to contact the patient’s VAD coordinator in the event an alarm appears on the patient’s System Controller; and to reinforce that System Controller exchanges are to be performed by a VAD Coordinator in the hospital.
- Customers are to sign and return the “Acknowledgement Form” attached to the “Urgent Medical Device Correction” letter.
Prior Thoratec Class I Recall
A prior Class I recall was initiated in early 2014 for Thoratec Corporation’ HeartMate II LVAS Pocket System Controller over insufficient labeling and training for patients who were switched from the prior EPC Controller.
The HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller recall included specific devices: Specific HeartMate II LVAS Implant Kit with Pocket Controller, HeartMate II LVAS Pocket System Controller, HeartMate II LVAD Pump and Pocket Controller Kit, and Pocket System Controller removed from packaging. These items were distributed from August 2012 to June 2014.
At the time of the recall, Thoratec had received five reports of serious injury and four reports of death tied to difficulty when changing from the primary system controller to a back-up system controller. All reports involved 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.
Design differences between the EPC System Controller and the Pocket System Controller mandated a different approach to the way in which the device is connected. If the controller is not properly connected, the device does not function.
On March 4, 2014, Thoratec Corporation sent an “Urgent Medical Device Correction” letter by email to all affected customers that identified the product, problem, and actions to be taken. Thoratec indicated that it intended to update labeling and training materials for the device to provide better instruction on connecting the driveline to the Pocket System Controller.
Filing a Defective Abbott-Thoratec HeartMate II OVAS Pocket System Controller Medical Device Lawsuit
If you or someone you know suffered injuries related to the use of Abbott Thoratec’s HeartMate II OVAS Pocket System controller medical device, you may have valuable legal rights. Our medical device lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).