FDA Flags Cardiac Perforation Risks During Leadless Pacemaker Implantation

Patrice Wendling

November 17, 2021

The US Food and Drug Administration (FDA) is reminding healthcare providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation.

Cardiac perforation is a rare complication and the overall risk associated with leadless pacemaker implantation appears similar to that with traditional transvenous pacemakers, the agency says. However, premarket clinical studies of the Micra leadless pacemaker (Medtronic) suggested major complications related to cardiac perforation appear to be more severe for those receiving a leadless pacemaker.

"Information from real-world use suggests that cardiac perforations associated with Micra leadless pacemakers are more likely to be associated with serious complications, such as cardiac tamponade or death, than with traditional pacemakers," the FDA said today in a letter to healthcare professionals.

"The FDA is bringing this information to your attention as a reminder and to encourage you to report leadless pacemaker cardiac perforations and complications related to perforation to the manufacturer and the FDA," it notes.

The Micra Transcatheter Pacing System in 2015 was the first leadless pacemaker approved in Europe, and was approved in the US the following year with a mandated postapproval study to help assess continued safety and efficacy. The Micra device is currently the only approved leadless pacemaker in the US.

The FDA continues to evaluate outcomes in patients who receive leadless pacing systems and recommends healthcare providers discuss the risks and benefits of available pacing system options with patients as part of shared clinical decision-making.

Providers are also advised to read and carefully follow the instructions for use (IFU) and training for Medtronic's Micra pacemaker.

Any adverse events or suspected adverse events related to the Micra Transcatheter Pacing System or any other pacemaker systems should be reported to the FDA through MedWatch, its adverse-event reporting program.

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