The FDA and Abbott are alerting healthcare providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems, a heart valve repair device manufactured by Abbott.
Abbott issued an urgent medical device correction on Sept. 8 about the clip lock malfunction. The malfunction has been observed before and after clip deployment with all device models and occurs in approximately 1.3 percent of MitraClip procedures.
The FDA stated the probable benefits continue to outweigh the probable risks associated with MitraClip. No adverse patient outcomes have been reported; however, some risks include:
- Ineffective treatment of mitral regurgitation.
- Potential need for additional procedures, which come with risks such as bleeding, complications with implanting additional clips and longer procedural times.