番茄社区

The FDA warned Monday of operator errors deploying the MitraClip mitral valve repair device that are prompting mandatory retraining for physicians using it.

Abbott Vascular initiated the voluntary safety notice based on nine cases (a 0.17% incidence rate) in which the MitraClip was . The company determined that operators failed to make a key maneuver -- returning the delivery system's arm positioner back to neutral -- during the deployment process, causing the mandrel component to fracture and the clip itself to remain attached to the delivery system.

The botched procedures required surgery to replace the mitral valve or remove the delivery system. One patient with severe comorbidities died following surgery, according to the company.

, of University of California Davis Medical Center, told 番茄社区 that these adverse events can be "rectified through a simple modification in how we release the clip," adding that such a change eliminates "any chance of malfunction."

Abbott Vascular revised the instructions for use and is requiring physicians to receive retraining. A field safety notice has been advising operators to review the correct steps for MitraClip implantation with a company representative before signing a training form.

There are 3,534 MitraClip devices on the market, of which one-third are in the U.S.

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