Abbott Laboratories issued a safety alert to customers regarding safety risks to cardiac patients that could arise from improper use of its MitraClip heart-valve repair device, as reported in Morningstar.
The company said that since 2008 it received reports of four incidents, including one death in the UK, in which physicians turned a knob on the device's delivery system the wrong way, resulting in complications.
Abbott indicated that incorrect usage of the device may require additional medical intervention or surgery, which could lead to complications "including post-procedural death."
The product has been on the market in Europe since 2008, and is also available in parts of Asia and Latin America. Abbott is also seeking approval to market MitraClip in the US, but an FDA advisory committee this week expressed doubts about the device's efficacy.
Company spokesman Jonathan Hamilton said three of the four patients had successful outcomes after surgical intervention following problems with the MitraClip knob, and said Abbott did not expect the issue to affect the FDA's review of the product.
The alert has no impact on patients who have been successfully treated with the MitraClip system, Hamilton noted. More than 8,000 patients have been treated with MitraClip to date.