Since the beginning of the summer, the Food and Drug Administration (FDA) has had to recall several medical devices that can cause serious injury or death for the general public. One of the most recent devices to be recalled was the HeartWare HVAD System distributed by the company Medtronic.
This recall comes as no surprise, as the company Medtronic issued an Urgent Medical Device Communication letter in June of this year urging health care providers to immediately stop the production and distribution of this device. As of the FDA’s publication notice, 4,620 devices have been recalled.
What is the HeartWare HVAD System?
The HeartWare Ventricular Assist Device (HVAD) is an internal pump that assists the heart in pumping blood throughout the rest of a patient’s body. This device is used by patients who are at risk of death as a result of end-stage heart failure (particularly, left ventricular heart failure), who are going through the process of heart tissue recovery, or who did not plan for heart transplants.
What are the reasons the device is being recalled?
The company Medtronic has stopped the distribution and sale of the HeartWare HVAD System for two main reasons. The first reason was that the company discovered an increased risk of patients suffering from neurological adverse events and mortality from using the pump. The second reason was that the pump had the possibility of immediately stopping, causing a delay in restarting or failing to restart altogether.
Both of these issues can create serious injury or death for the patients using the pumps. Some of the conditions that patients would have encountered as a result of a defect in the internal pump include stroke, heart attack, worsening heart failure, and additional treatments and hospitalizations.
Reports from Medtronic
Reports from Medtronic show not only statistical data that proves the impact of the device’s defect on patients, but complaints from patients that described the defect in the device. A collection of clinical comparisons showed a greater frequency of neurological adverse events and mortality in patients who used the HVAD System. The results were compared to patients who use other available and durable left ventricular assist devices (LVAD). Medtronic also received over 100 complaints about the internal pump, where patients complained about a delay or a failure to restart. Sadly, these medical product defects led to the deaths of 14 people and pump removal from 13 patients.
What are the recommendations for physicians?
On June 3, Medtronic notified health care providers through an Urgent Medical Device communication letter of the decision to recall the device. The letter recommended that physicians immediately stop the new implants of the HeartWare HVAD System, to continue normal use of peripherals, and contact Medtronic for replacement of the peripheral components. Physicians were also recommended to complete a Customer Confirmation form and email the form to a provided email.
What are the recommendations for patients using HVAD Support?
The letter also explained how health care providers can move forward with patients, depending on their situation. For patients that were currently on HVAD support at the time that the letter was issued, health care providers were advised not to remove HVAD devices that were already implanted in the patient. The risks that come with removing the device may outweigh the potential benefits.
Decisions surrounding the removal and exchange of the HVAD pump should be made based on each unique case. When and if healthcare providers make those decisions, factors such as the patient’s clinical condition and surgical risks will be taken into account.
Healthcare providers were also advised to continue following the instructions provided in the instructions for use (IFU) and rely on current best clinical practices. Some of the clinical practices recommended by the company include strict management of blood pressure and International Normalized Ratio (INR), and the use of system log files to assist with clinical decision making.
Patients were advised to continue using the HVAD System peripherals that were consistent with the IFU and were advised to contact their clinic if a replacement was needed. Patients were also warned to never disconnect the pump from two power sources at the same time, and to always have a back-up controller and fully charged spare batteries at their disposal.
Recommendations for patients in need of LVAD placement
Patients who are in need of LVAD placement were advised to use an alternative commercial LVAD. If the alternative commercial LVAD was not accessible for patients in urgent need, patients and their physicians were required to complete a Patient Information form to acknowledge the risks of the Medtronic HVAD implant. Medtronic also offered to collaborate with “HVAD only” centers to formulate a transition plan to an alternative LVAD. Part of that collaboration included the facilitation of training on an alternative device for “HVAD only” implanting centers.
What are the most recent updates?
On July 7, Medtronic issued a follow-up to the Urgent Medical Device Communication letter, providing instructions for returning some HVAD inventory. The company informed healthcare providers that peripherals and HVAD surgical tools should be kept and used to manage any patients that could still be on support. The items should also be returned if healthcare providers do not have patients on support. Clinical sites are to follow the instructions in the follow up letter and only return certain components of the HeartWare HVAD System.
The FDA also reported that, on August 10, Medtronic issued a letter to healthcare providers informing them a communication concerning the decision to Halt HVAD Distribution to all Medtronic HVAD patients would be issued separately. The FDA recommends that healthcare providers follow the instructions provided in Medtronic’s Communication Notification letter. The FDA also recommended the use of the alternative device Abbott HeartMate 3 LVAD instead of the HVAD System.
Have you been injured by a defective medical device? The Mississippi defective medical products attorneys at Merkel & Cocke, P.A. provide legal counsel for clients from Jackson, Clarksdale, Greenville, Oxford, Tupelo, and the Gulf Coast Region. Call us at 662-627-9641, or complete a contact form to schedule a consultation with a member of our team today.
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