Leading medical device manufacturer Medtronic has issued its second recall in as many weeks involving recently developed technology. Coming off of the European recall of its MiniMed 640 insulin pump last week, which is scheduled for a Pre-Market Approval (PMA) review in the U.S. later this year, the company has recalled nearly 7,000 EnVeo R loading systems for its CoreValve Evolut R replacement heart valve. The recall comes after reports of particulates being found in some of the shipments. The Food and Drug Administration (FDA) has labeled the recall a Class I, meaning “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Medtronic issued a letter to customers affected by the recall as well as posting the letter on Germany’s Federal Institute for Drugs and Medical Devices web site. The letter, which contains the affected lot numbers, urges consumers to cease using the product and return the lading systems to Medtronic, as the company will help order replacements.
In the letter, Medtronic wrote that:
“The presence of particulate in the EnVeo R Loading System has the potential to be transferred to the Transcatheter Aortic Valve (TAV) and released into the patient’s vasculature after deploying the TAV. If this were to occur, potential harms may include embolism into the bloodstream. While Medtronic has received only 8 reports of particulate identified from the loading system, with no reports of adverse patient effects, bench testing has demonstrated a higher prevalence of particulate and the potential for its transfer to the TAV.”
The FDA only recently approved the device for use in the U.S. in June. Medtronic spokesperson, Wendy Dougherty wrote in an email that all of the affected devices have already been removed from the market and that none of the recalled devices were sold commercially in the U.S. The FDA notice states, however, that 540 of the devices are in use in the U.S., with the rest in use by customers in Europe and other countries where the devices had been approved months prior. In the email, Dougherty said that “The issue has already been resolved with the introduction of a process improvement in manufacturing.” Among the eight reports of particulate matter found, there have been no reported deaths or injuries related to the recall.
According to a company statement, “This issue does not affect other Medtronic devices or other components of the Evolut R TAV system.” The Evolut R is a device used by patients who have had a transaortic valve replacement (TAVR). It is designed for those patients who have severe aortic stenosis, which is when the aortic valve narrows, making surgery too risky. Medtronic representatives believe that their device is superior to that of its chief rival, the Sapien 3 from Edwards Lifesciences, which was also approved by the FDA in June, because its construction makes it more adjustable, preventing issues like paravalvular leak. Although Medtronic’s base is in Findlay Minnesota, it is actually an Irish company following a series of mergers and acquisitions. It is currently the third-largest medical device company in the world and the market leader for diabetes and pacemaker devices, among others.
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