Abbott Laboratories is recalling a device used to implant clips into the mitral valve of the heart because a number of surgeons were unable to detach the device from the clip during surgery.
The Abbott Park, Ill.-based company's vascular division says it will retrain surgeons after nine devices malfunctioned, resulting in one death. Providers told Abbott that they were unable to detach the clip from the catheter used to implant it. They were therefore forced to perform open-heart surgery to retrieve the delivery device or replace the mitral valve.
The company issued a voluntary safety notice in February explaining that surgeons were not correctly returning the device's “arm positioner” to a “required neutral position,” which prevented the clip from detaching. Abbot is continuing to ask providers to carefully read the device's instructions and participate in a training with a company representative.
The death related to the Class 1 recall was the result of severe comorbidities after surgery. It's thought that surgery would be required to resolve the issue in any similar incidents in the future, according to the Food and Drug Administration. Class I recalls are the most serious, indicating that use of the device can cause serious injuries or death.
There are 3,534 MitraClip devices on the market. The FDA approved the MitraClip in October 2013, and it is the only device of its kind on the market.
The MitraClip is used to clip together a portion of the mitral valve leaflets to reduce mitral regurgitation, which refers to the backflow of blood caused by a failure of the valve to properly close. For patients whose risk factors prevent them from having open-heart surgery to repair or replace the valve, MitraClip may be their best hope, doctors say.
When the MitraClip was initially introduced, providers were concerned that the CMS was not reimbursing them enough to cover the longer length of stay and higher costs that come with implementation of the device, which sold for about $30,000 at the time. Hospitals say they were being underpaid by as much as $17,000.
The CMS declined to change its codes as interventional cardiologists requested but did offer a new technology add-on payment that resulted in an estimated $27 million in additional payments for fiscal 2015. Medicare only covers the device if the heart team and hospital involved in the procedure are participating in a registry that follows patients for at least one year and tracks patient outcomes.