CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Edwards Lifesciences has issued a letter to affected customers recommending certain delivery systems used for SAPIEN M3 transcatheter mitral valve replacement be removed from where they are used or sold. Affected devices:
- Commander M delivery systems (for SAPIEN M3 Transcatheter Mitral Valve Replacement System)
- Lots: 67718561, 67804014, 67887043, and 67887044
What to Do
Do not use the identified affected products listed above. Units with other lot numbers are not impacted by this recall and can continue to be used.
On October 5, Edwards Lifesciences sent all affected customers a letter recommending the following actions:
- Share this notice with appropriate clinical staff at your site.
- Search your inventory for and remove the affected product.
- Work with your Edwards Representative to return any impacted product to Edwards.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Edwards Lifesciences stated it has received three reports of balloons bursting during inflation. Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath, which may require additional intervention, including surgery. Because this patient population is deemed unsuitable for surgery, these interventions carry a high risk of serious adverse health consequences including death.
As of October 5, Edwards Lifesciences has reported one death and one serious injury associated with this issue.
Device Use
The Commander M delivery systems are used to deliver a replacement mitral heart valve to a patient’s heart through their blood vessels, without requiring open chest surgery.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Edwards Lifesciences at 1-800-424-3278 or CustomerServ_TMTT@edwards.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
