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.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
