NEWS ALERT: US_FDA is alerting HCPs about the potential for clip lock malfunctions with Abbott's MitraClip's delivery system.
" to providers today, Abbott reports a recent increase in reports of the clips failing to"establish final arm angle " and of"clip opening while locked " events.
COWL describes when the clip arm angle increases post-deployment."In these cases, users observe a slippage in the lock, resulting in an Arm angle greater than 10 degrees from the angle observed at deployment," which can be identified through fluoroscopy, Abbott says. Despite the increase in reports, the acute procedural success rate remains consistent with historical data, according to Abbott."Further, EFAA failure or COWL most often results in no adverse patient outcomes. COWL may lead to less MR reduction, which is often treated with the use of one or more additional clips."
"In any case where significant residual MR is observed after Clip deployment, a second Clip should be considered and implanted in accordance with the IFU [instructions for use]," it advises.
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