FDA Early Alert: Edwards Mitral Valve Delivery System Balloons Burst During Inflation; One Death, One Serious Injury Reported, Four Lots Pulled
The U.S. Food and Drug Administration on October 15 issued an Early Alert saying that certain Commander M delivery systems made by Edwards Lifesciences for use with the SAPIEN M3 transcatheter mitral valve replacement system present a potentially high-risk issue. The Center for Devices and Radiological Health issued the alert, and the FDA said it is reviewing information about the problem.
According to the FDA, Edwards has written to affected customers recommending that the delivery systems be removed from where they are used or sold. The affected Commander M systems cover four lots: 67718561, 67804014, 67887043 and 67887044. Units with other lot numbers are not impacted and can continue to be used.
On October 5 the company sent the letter to all affected customers, asking them to share the notice with appropriate clinical staff, search inventory for the affected product, remove it, and work with their Edwards representative to return it.
Edwards has received three reports of balloons bursting during inflation, the FDA said. A balloon burst can cause embolism or leave the device unable to be retrieved through the guide sheath, which may require additional intervention, including surgery — interventions that carry a high risk for this patient population, which is deemed unsuitable for surgery. As of October 5, the company had reported one death and one serious injury associated with the issue.
The FDA said it will keep the public informed and update its alert as significant new information becomes available.
Published by GSM · USA (original Chinese edition)
Photo: 心导管实验室介入手术资料画面（非涉事器械）· 美国海军医学 摄，公共领域（维基共享资源）
