The FDA alerted healthcare providers about the potential for clip lock malfunctions with Abbott LaboratoriesABT MitraClip’s delivery system to stop heart valve leakage.
“These events appear to occur in approximately 1.3% of MitraClip procedures and have been observed with all device models,” the FDA said in a letter.
The MitraClip device was approved in 2013 for patients with symptomatic, degenerative mitral regurgitation (MR) deemed high risk for mitral-valve surgery.
In its own “urgent medical device correction letter” to providers today, Abbott reports a recent increase in reports of the clips failing to “establish final arm angle (EFAA)” and of “clip opening while locked (COWL)” events.
During device preparation and before clip deployment, the operator intentionally attempts to open a locked clip to verify that the locking mechanism is engaged.
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,” Abbott says this can be identified through fluoroscopy.
From February 2021 to January 2022, the EFAA failure rate was 0.51% and the COWL rate 0.28%, increasing to 0.80% and 0.50%, respectively, from February 2022 to July 2022, according to Abbott.
According to Abbott, despite the increase in reports, the acute procedural success rate remains consistent with historical data.
Most reported clip lock malfunction events have not been associated with adverse patient outcomes.
Price Action: ABT shares traded 0.12% higher at $107.12 during pre-market trading on Friday.
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