We don’t know whether the FDA has its pen hovering over the tick box for MitraClip or not, but the advice of its circulatory devices panel was to approve the thing. We also don’t know whether a warning letter issued to European users, of a potential device malfunction, might colour the decision. It probably won’t, but it’s not great timing.
Abbott Vascular has issued a warning letter over its clever Mitral valve clip, the eponymous MitraClip. It seems that if the operating cardiologist turns the deployment knob the wrong way (clockwise vs anti-clockwise), this can adversely affect the deployment of the clip on the other end of the apparatus.
The device was launched in Europe in 2008 and to date there have been only four such reported incidences, but nonetheless the company is having to issue a warning notice to all users because of the serious consequences of this malfunction. Remember the device is largely being used selectively on patients for whom conventional valve surgery is not an option due to their serious disease condition. A misfiring MitraClip may well require reversion to the very open surgery it was conceived to avoid, which introduces the patient to potentially life-threatening risks.
It’s important to say that Abbott is not recalling the MitraClip device, judging that by issuing a warning, cardiologists should be adequately alerted to the risk. Indeed the instructions for use already direct the operator to turn the actuator anti-clockwise and emphasise that turning it the wrong way could result in a failure to deploy. The company is now to add a directional arrow to the device itself, but considers the current product out there to be safe to use with the additional warning.
Warning letter here.
Source: Abbott Vascular