The U.S. Food and Drug Administration (FDA) has announced a Class I Recall of Abbott’s MitraClip Delivery System following the company’s voluntary release of a safety notice warning of the device’s failure in 9 reported surgical cases. In these cases, surgeons were unable to separate the clip implant from the delivery system. All 9 patients required emergency open-heart surgery because of the botched non-surgical mitral heart valve repair procedures; 1 died.
The FDA defines a “Class I Recall” as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Abbott Vascular has not recalled the medical device, claiming that the MitraClip system failed due to user error in returning the ‘arm positioner’ to a required neutral position rather than to technical defects in the product itself. Instead, it is now requiring formal training of physicians who implant the clip, as well as revising the text of the product’s “Instructions for Use.”
What You Should Know About Abbott’s MitraClip Technology
- Abbott’s MitraClip Delivery System, a transcatheter which allows surgeons to treat patients with degenerative mitral regurgitation (a leaky heart valve) who are too high-risk for surgery, was only approved by the FDA for use in the United State in 2013; it is currently the only FDA-approved transcatheter mitral valve repair device, generating more than $250 million per year for Abbott Vascular (2).
- Prior to FDA approval in the U.S., the MitraClip system was utilized fairly extensively in western Europe – of the 3,543 MitraClips currently marketed by Abbott, 2,246 are targeted to markets outside of the U.S. (2).
- Significantly, between March and April 2013, officials in the United Kingdom reported a separate issue with the Clip Delivery System where the Actuator Knob, when turned in the wrong direction, prevented successful deployment of the clip, requiring emergency open-heart surgical repair of the very patients who were undergoing the procedure because traditional mitral valve surgery was considered too life-threatening for them (3).
- The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) investigated four [4] reports of device failure; in one case, a U.K. patient died of renal complications a week following the surgery. After being alerted by MHRA to the device failure, Abbott responded in almost the same fashion as it is currently addressing the present ‘arm positioner’ issue: it issued a Field Safety Notice (FSN) to medical practitioners. In this case, it also marked newer devices with a blue turn arrow and promised to make design changes over the next two years that would make it impossible to turn the knob in the wrong direction (3).
Is Abbott Responsible For Injuries from the MitraClip Delivery System?
If you or a loved one required unanticipated, high-risk open heart surgery as a result of MitraClip failure, please contact our law firm using our free consultation form to see if you have the right and the grounds to sue for compensation for personal injury or wrongful death.
Sources:
1) Web Page. “Safety: Backgrounds and Definitions.” U.S. Food and Drug Administration. Web. 24 Jun. 2009.
2) Saxena, Varun. “FDA warns of dangerous errors made during implantation of Abbott’s MitraClip.” FierceMedicalDevices. Web. 1 Mar. 2016.
3) Press Release. “MitraClip Clip Delivery System – risk of death or serious harm.” Medicines and Healthcare Products Regulatory Agency. 19 Mar. 2013.
