FDA Update: Agency Warns of Complications Related to Cardiac Perforation During Leadless Pacing System Implantation

The U.S. Food and Drug Administration (FDA) on Nov. 17 issued a letter to providers warning about a risk of major complications if cardiac perforation occurs during implantation of the Medtronic Micra Transcatheter Pacing System. The Micra leadless pacemaker was approved by the FDA in 2016 and is the only approved and marketed leadless pacemaker in the U.S.

According to the letter, the overall risk of cardiac perforation is low, but real-world data suggests that patients who experience cardiac perforations with the Micra system are more likely to experience complications, such as cardiac tamponade or death, compared with patients who experience perforations with traditional pacemakers. Cardiac perforation can lead to complications or death.

The FDA has received more than 300 medical device reports for the Micra system since its approval in 2016, more than 90 of which described a perforation resulting in death. The agency is working with the manufacturer to evaluate information, including postmarket studies and real-world data. FDA recommended that providers discuss risks and benefits of available pacemaker systems with patients and encouraged providers to report any adverse or suspected adverse events to help the agency better understand the risks associated with the device.

Read the full FDA letter.

Clinical Topics: Pericardial Disease

Keywords: ACC Advocacy, Heart Injuries, Pacemaker, Artificial, United States Food and Drug Administration, Cardiac Tamponade

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