MitraClip Manufacturer Issues Safety Notice on Proper Deployment
Abbott has voluntarily released a safety notice about the MitraClip, its transcatheter mitral valve repair device, the US Food and Drug Administration noted in an alert issued late last week.
The safety notice concerns the deployment process for Commercial Clip Delivery Systems with lot numbers of 50714U1 or greater, the FDA stated.
Thus far, the company has received nine reports of malfunction. According to the FDA, “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 [MitraClip] from detaching.”
The incidence of malfunction amounts to 0.17%, the FDA says. All cases required surgery to remove the delivery system or replace the mitral valve, the agency reports, adding, “There was one patient death in these cases as a result of severe comorbidities following surgery.”
Currently there are 3,534 MitraClip devices on the market, with approximately one-third located in the United States. While Abbott is not recalling the product, the company is requiring all implanting physicians to undergo training about the issue and incorporating the proper deployment sequence into the MitraClip’s instructions for use.
The FDA is encouraging clinicians to report any adverse reactions and/or quality problems to Abbott and to MedWatch.
Food and Drug Administration: Abbott issues voluntary safety notice on MitraClip delivery system deployment process. http://www.fda.gov/Safety/Recalls/ucm488133.htm. Published on: February 26, 2016. Accessed on: February 29, 2016.