FDA issues reminder of cardiac perforation risk during leadless pacemaker implantation
In an advisory letter, the FDA reminded clinicians of the risk for major complications should cardiac perforation occur during leadless pacemaker implantation and highlighted the importance of reporting adverse events and complications.
Real-world data indicated that cardiac perforations associated with Medtronic’s leadless pacemakers (Micra) are associated with more severe complications, such as cardiac tamponade or death, compared with traditional pacemakers, according to the letter.
According to the letter, cardiac perforation is rare of any pacemaker system implant but can lead to major complications or death.
The FDA encouraged clinicians to report cardiac perforations associated with leadless pacemaker implantation to the manufacturer and the FDA.
The FDA provided the following recommends for clinicians:
- Discuss risks/benefits of pacemaker options with patients as part of shared decision-making.
- For each patient, consider the risk/benefit profile of the leadless pacemaker option compared with transvenous systems or alternative treatment options.
- Although cardiac perforation is rare, the risk for major complications in the occurrence of perforation may be higher in leadless pacemaker implantation compared with traditional transvenous pacemakers.
- Implanting physicians should be prepared to emergently manage patients experiencing perforation during leadless pacemaker implantation.
- Read and carefully follow the instructions for use and training for the Medtronic leadless pacing system.
- Report any adverse events or suspected adverse events experienced with the Medtronic leadless pacing system or other pacemaker systems.
According to the letter, the FDA is working with the manufacturer to identify contributing factors to cardiac perforation following leadless pacemaker implantation, mitigation measures and to ensure the product labeling adequately addresses the issue.