FDA Warns of Clip Lock Malfunctions With Abbott's MitraClip Heart Valve Devices

FDA Warns of Clip Lock Malfunctions With Abbott's MitraClip Heart Valve Devices
  • The FDA alerted healthcare providers about the potential for clip lock malfunctions with Abbott Laboratories ABT 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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