The U.S. Food and Drug Administration (FDA) is reminding providers about the risk of major complications if cardiac perforation occurs during leadless pacemaker implantation. Cardiac perforation is a rare complication of any pacemaker system implant. Cardiac perforation can lead to major complications or even death.
The overall risk of cardiac perforation associated with leadless pacemaker implantation appears similar to the risk associated with traditional transvenous pacing systems. However, the Medtronic Micra leadless pacemaker premarket clinical studies suggested major complications related to cardiac perforation appeared to be more severe for patients who received a leadless pacing system compared to patients who received a transvenous pacemaker, according to an FDA press release. The agency continues to evaluate outcomes in patients who receive leadless pacing systems. 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 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. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. The FDA is working with the manufacturer to evaluate information from all available sources, including post market studies and real-world data, to provide additional information on this issue.
The FDA recommends that healthcare providers:
Discuss the risks and benefits of available pacemaker system options with patients as part of shared clinical decision-making.
The benefit-risk profile of leadless pacing systems compared to transvenous systems or alternative treatment options should be considered for each patient.
Be aware that although cardiac perforation is a rare complication following pacemaker system implant procedures, the risk of major complications following cardiac perforation may be higher in patients who receive leadless pacing systems vs. traditional transvenous pacemakers.
Implanting physicians should be prepared to emergently manage patients experiencing perforation during leadless pacemaker implantation. In some cases, urgent cardiac surgical intervention may be necessary.
Read and carefully follow the Instructions for Use (IFU) and training for the Medtronic leadless Micra Transcatheter Pacing System, which include recommendations about implant location at the right ventricle septum, delivery system steering, repositioning the device, patient selection to minimize perforation risk, stand-by availability of cardiothoracic surgery, and immediate access to echocardiography equipment.
Report any adverse events or suspected adverse events experienced with the Micra Transcatheter Pacing System or other pacemaker systems. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
The FDA is working with the manufacturer to evaluate outcomes after cardiac perforation following implantation of leadless pacemaker systems to identify potential contributing factors and mitigation measures, and to ensure the product labeling adequately addresses the issue. The FDA will continue to monitor reports of adverse events and other sources of postmarket data associated with leadless pacemaker systems and will update the public if new or additional information becomes available.
