Abbott Vascular (NYSE:ABT) warned physicians about the slight risk that its MitraClip heart valve implant could be damaged if the device is misapplied during implantation.
The Temecula, Calif.-based medical device company said in a field safety notice that it’s received 4 reports since 2008 in which the MitraClip mitral valve repair system’s "actuator knob" was turned in the wrong direction, damaging the clip and preventing deployment."
"This situation may require additional medical intervention or conversion to surgery, which could lead to complications including post-procedural death," according to the notice.
Abbott Vascular spokesman Jonathon Hamilton told MassDevice.com in an email that "MitraClip has been implanted in more than 8,000 patients in 30 countries since 2008," meaning that the 4 reported cases represent only 0.05% of implantations. The advisory notice went to all physicians using the MitraClip device in the U.S. and internationally, Hamilton told us.
The company "completed the corrective actions to add a directional arrow on the actuator knob of newly manufactured devices to aid in proper clip deployment," according to the advisory, which noted that current MitraClip inventories are safe as long as the directions are followed. Successful implants are not affected, Abbott said.
Hamilton said last week that 3 of the 4 patients involved had successful outcomes after further interventions, but couldn’t supply additional details, Dow Jones newswire reported.