It was reported this was an off-label mitraclip procedure to treat tricuspid regurgitation (tr) with a grade of 5 and a rotated heart.It was noted imaging was difficult throughout the procedure.One xt clip was inserted and successfully implanted.A second xt clip (31002a2082) was inserted and deployed on the tricuspid valve.To further reduce tr, a third xt clip (31002a2063) was inserted and advanced under the tricuspid valve.However, during placement of the third clip, it became caught in the chordae and resulted in the second implanted clip detaching from the septal leaflet and remaining attached to the posterior leaflet (single leaflet device attachment/slda).The third clip was able to be removed from the chordae and was deployed to stabilize the slda.However, after deployment, tissue damage was observed.To further stabilize the slda, an additional forth xt clip was implanted, reducing tr to a grade of 1.There was no clinically significant delay in the procedure.
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated the reported image resolution poor was related to procedural conditions as imaging was difficult throughout the procedure.A cause for the reported difficult to remove the clip from the anatomy could not be determined.The reported off-label use of the device was associated with the mitraclip device being used to treat tricuspid regurgitation (tr).Unspecified tissue injury appears to be due to procedural conditions associated with difficulty removing the clip from the anatomy.Tissue damage is a known possible complication associated with mitraclip procedures.Serious injury/ illness/ impairment was a result of case-specific circumstances as no treatment was provided for the tissue injury.There is no indication of a product issue with respect to manufacture, design or labeling.
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