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 the reported event.A review of the complaint history identified no similar complaints from the lot.Based on the information reviewed, while the difficulty removing the lock line (physical resistance/sticking) appears to be the result of the knot (material deformation), a cause for how the knot formed could not be determined.There is no indication of product issue with respect to manufacture, design or labeling.Na.
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It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An mitraclip nt was inserted and placed on the mitral valve.While attempting to deploy the clip, a knot was observed on the lock line (ll).The ll was removed without issues.The clip was successfully deployed, reducing mr to trace.There was no clinically significant delay in the procedure.
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