Voluntary Safety Notice Issued for Abbott Vascular's MitraClip Delivery System Deployment Process

February 29, 2016—Abbott Vascular announced it has initiated a voluntary safety notice regarding the MitraClip delivery system to reinforce the proper procedures used to operate and deploy the device. The company received a small number of reports involving MitraClip delivery systems in which the user was unable to separate the implantable clip from the delivery system. Commercial MitraClip delivery systems with lot numbers 50714U1 and greater are within the scope of this action. Individuals who have already had the device implanted are not affected by this action.

The MitraClip delivery system is a minimally invasive device used for the treatment of degenerative mitral regurgitation. Presently, there are 3,534 devices on the market (1,288 in the United States and 2,246 outside the United States). Abbott has received nine Medical Device Reports of malfunction.

According to Abbott Vascular, the company's investigation determined that the delivery system's “arm positioner” was not returned to the required neutral position by the operator during the deployment sequence, subsequently preventing the clip from detaching. All of these cases (0.17% incidence) resulted in surgical interventions to remove the delivery system or replace the mitral valve, and it is expected that any future similar incidents would also require surgery to correct the problem. There was one patient death in these cases as a result of severe comorbidities after surgery, advised the company.
 
The US Food and Drug Administration (FDA) has classified this safety notice as a class I recall. The company is not removing the product from commercial distribution. 

Abbott Vascular is requiring training of all MitraClip implanting physicians on the safety notice to ensure continued safe use of the device and is incorporating the safety notice's deployment sequence in its instructions for use.

Additionally, the company stated that customers with questions or concerns should contact their Abbott Vascular representative or call the company at 1-800-227-9902. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to Abbott and to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch website at www.fda.gov/medwatch.