Abbott cautions on potential issue with MitraClip heart implant

Abbott (NYSE:ABT) warned surgeons earlier this month about a potential issue with its MitraClip after receiving 9 reports of problems that led to surgical interventions.

In a Feb. 4 urgent field safety notice, Abbott Vascular said the reports indicated that the delivery system for the MitraClip device, which is designed to repair the heart’s mitral valve, malfunctioned during implantation procedures. In 1 of the cases the patient died after the procedure due to “severe comorbidities,” according to the notice.

Surgeons should make sure that an internal component of the delivery system called a mandrel is not under tension before deploying the clip, Abbott said. Although the current indications for use require that the tension be set to neutral before deployment, Abbott Vascular said it’s revising the IFU “to provide additional assurance that tension is completely eliminated prior to deploying the Clip. Abbott Vascular will train all MitraClip implanters on the revised instructions.”

Abbot received FDA approval for the MitraClip in 2013 after some contention within the FDA over its efficacy. Evidence from the Everest II clinical trial in 2014 showed positive results after a year of monitoring the device’s use in patients, showing an 84% reduction in mitral regurgitation after treatment.

Last year at the annual Heart Rhythm Society meeting, researchers reported results from a study of patients with implanted cardiac rhythm devices showing a 50% overall reduction in ventricular tachyarrhythmias.

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