This is filed to report material extrusion.It was reported this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 4.One xt clip was successfully deployed on the tricuspid valve.To further reduce tr, an additional xt clip was inserted and placed on the tricuspid valve.However, during deployment, after rotating the actuator knob eight times, the actuator knob was pulled but the mandrel retracted roughly 2-3 inches.The clip was deployed without further issues, reducing tr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported material separation (actuator knob) was determined to be a normal function of the device after clip deployment.The reported off-label use was due to the device being used on a tricuspid valve.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: code 2979 has been removed.
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