Government health officials have issued a Class I medical device recall for certain heart surgery delivery systems used to treat dysfunction in the mitral valve, after at last nine reports of problems where the device malfunctioned, including at least one death and instances where emergency open heart surgery was required to retrieve the delivery system.
The Abbott Vascular MitraClip Delivery System recall received the FDA’s highest threat classification on March 15, following indicating that the product defect has a probability of causing serious injury or death.
If the heart surgery delivery system fails to detach from the Clip due to a malfunction of the device, immediate open heart surgery is often necessary to retrieve the system. To date, there have been at least nine adverse health consequences resulting from the device, including one death.
The Vascular MitraClip Delivery System is designed to treat patients with degenerative mitral regurgitation, which is a condition that causes a dysfunction in the heart’s mitral valve. The device consists of a delivery catheter, steerable sleeve, and an implantable clip.
To prevent reverse blood flow into the patient’s heart, the implantable clip is threaded through the steerable sleeve and the delivery catheter into the left atrium of the heart. The implantable clip is then positioned and closed between the leaflets that separate the left atrium and the left ventricle. The clips positioning helps prevent degenerative mitral regurgitation.
Reports indicate that the Clip Delivery System sometimes does not properly detach from the clip that was placed in between the leaflets. Abbott Vascular’s recall notice indicated that their investigation determined 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.
The recall includes an estimated 3,535 Abbott Vascular MitraClip Delivery Systems, including 1,288 in the United States and 2,246 outside the United States. The systems were manufactured by Abbott Vascular from July 14, 2015 to August 11, 2015. The devices were distributed for sale to healthcare physicians and medical centers across the U.S. and Puerto Rico from August 28, 2015 to February 3, 2016. The recall notice linked above contains a full list of the recalled MitraClip Delivery System Lot numbers.
On February 4, 2016, Abbott Vascular issued a Safety Notice directing all physicians to stop using the recalled MitraClip Delivery Systems, to carefully read the revised deployment sequence instructions and to participate in new training sessions with an Abbott Vascular representative. Physicians are being encouraged to share the recall and new protocol information with other pertinent staff members.
The FDA labeled the MitraClip Delivery System recall with “Class I” status this week, representing the most serious type of recall.
Customers with concerns regarding the recall may contact Abbott Vascular Customer Support at 1-800-227-9902. Patients about to undergo a mitral regurgitation procedure should consult with their physicians about the type of delivery system being used.