Safety Notice Issued on Abbott's MitraClip Delivery System

Megan Brooks

Disclosures

March 02, 2016

Abbott has issued a voluntary safety notice to "reinforce the proper procedures used to operate and deploy" the company's MitraClip Delivery System.

The company said it has received a small number of reports involving MitraClip Delivery Systems in which the operator was unable to separate the implantable clip from the delivery system. Abbott has received nine medical device reports of malfunction, according to a company statement posted February 29 on the US Food and Drug Administration (FDA) website.

Abbott said their investigation into the matter found that the delivery system's arm positioner was not returned to the required neutral position by the operator during the deployment sequence, which prevented 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," the company said. One patient died as a result of severe comorbidities after surgery.

Abbott said it will require 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."

The MitraClip Delivery System is a minimally invasive device used to treat people with degenerative mitral regurgitation. Currently, there are 3534 devices on the market — 1288 in the United States and 2246 outside the United States — according to the company.

Abbott said MitraClip delivery systems with lot numbers 50714U1 and greater are affected by this action. Patients who have already had the device implanted are not affected by this action.

The FDA has classified this safety notice as a class 1 recall, although Abbott is not removing the product from commercial distribution.

Physicians with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.

To report any problems with these devices, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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