Abbott 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 where the user was unable to separate the implantable Clip from the delivery system. 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.
Abbott'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 following surgery.
The U.S. Food and Drug Administration (FDA) has classified this safety notice as a Class I Recall. Abbott is not removing product from commercial distribution. Abbott 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.
Commercial Clip 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.
Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.
The MitraClip Delivery System is a minimally invasive device used to treat people with degenerative mitral regurgitation (DMR) a condition involving a dysfunction of the heart's mitral valve.
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 atwww.fda.gov/medwatch.
The above post is reprinted from materials provided by U.S. Food and Drug Administration. Note: Materials may be edited for content and length.
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