Another Medtronic HVAD Recall: Driveline Cover May Stick, Delaying Vital Patient Care
Adding to a growing list of design defects associated with the Medtronic HeartWare Ventricular Assist Device (HVAD), another recall has been announced by the manufacturer, this time linked to a driveline cover that may become stuck in place, delaying important patient care.
Medtronic issued an urgent medical device communication (PDF) on November 29, following reports of the driveline cover, which covers the driveline connector that must be detached in order to change the device’s controller, becoming hardened and stuck in place, which could prevent the controller from being changed in a timely manner.
The Medtronic HVAD was previously used for individuals at risk of death from end-stage left ventricular heart failure, involving an implanted medical device intended to help pump blood from the heart to the rest of the body. Typically the pump has been used while individuals are waiting for a heart transplant, but the HVAD has been plagued with problems.
While there are many life-saving benefits of Medtronic’s HVAD mobility, the devices have been subject to at least 17 Class I recalls over defective components since they were approved by the FDA in November 2012, and the agency removed the HVAD from the market in June 2021, after identifying more than 3,000 report involving patient deaths. However, federal health officials do not recommend doctors remove the HVAD, unless an individual is experiencing problems. Therefore, many individuals face continuing risks from the device.
According to this latest warning, which is being considered a recall by the FDA, Medtronic has received 33 complaints of driveline covers becoming stuck. While no serious injuries or deaths have been linked to the problem, Medtronic warns the driveline cover hardening and becoming stuck in place could lead to delays in changing the controllers and potentially other problems.
However, it comes less than two months after Medtronic released modified software for backup controllers, due to problems with the HVAD failing to restart after due to controller problems, which has resulted in a number of patient injuries and deaths.
The new algorithm for the backup controllers could potentially address these problems and help get the system restarted, but if the driveline connector is stuck and the controller cannot be changed, this could negate the potential benefits of the software update.
Medtronic indicates the problem is due to plasticizer loss, which may be accelerated by environmental factors, which leads to the driveline cover, which should be soft and malleable, becoming hard, stiff and difficult to remove.
“Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector,” Medtronic’s letter warns. “Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed.”
Medtronic recommends that when this hardening is observed, a Medtronic field representative should be contacted for further assessment and servicing, if needed.
The manufacturer also recommends healthcare professionals check to ensure the driveline cover is not stuck or hardened and can be pulled back from the driveline connector before exchanging a controller. The company also recommends the driveline cover be checked during routine clinic visits, to make sure it is not stuck or hardened.
The urgent medical device correction letter calls for healthcare providers to complete a Customer Confirmation form to acknowledge they received the notification, and urges them to share the notice with all healthcare professionals who need to be aware of it in their organization. Adverse events linked to this problem should be reported to the FDA’s MedWatch adverse event reporting program.
Medtronic HVAD Problems
Last summer, the FDA announced Medtronic was removing its HVAD systems from the market, due to an unreasonable risk of neurological events and increased death rates among patients. However, many individuals still had the device implanted, and the FDA did not recommend they have the Medtronic HVAD removed at the time, if there were no problems detected.
According to an August 2021 investigation by ProPublica, FDA inspectors began voicing concerns about Medtronic HVAD systems as early as January 2014, following a HeartWare recall in late December 2013, which was issued because the device could fail and stop pumping, leading to serious injury and death.
FDA investigators issued a warning letter a month later, after identifying a number of deficiencies at the HeartWare manufacturing facility in Miami Lakes, Florida, particularly involving the process for making sure that some corrections made to the HVAD actually work.
The ProPublica investigation lay the blame at the FDA’s feet, saying the agency allowed more than 19,000 patients to be implanted with the heart pump, most of whom received their implants after the FDA had determined the HVAD did not meet federal safety standards.
When the devices were removed from the market in June 2021, the FDA indicated it had received more than 3,000 reports of patient deaths by the end of 2020, all linked to HeartWare implant problems.
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