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Early Alert: Transcatheter Mitral Valve Delivery System Issue from Edwards Lifesciences
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
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.
Questions?
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.
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