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 identified no similar complaints reported from this lot.Based on available information, the cause of the reported knotted lock line was unable to be determined.The reported difficult to remove lock line was a cascading event of the reported knotted lock line.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation with grade 4.A mitraclip xtw was inserted and placed on the mitral valve.While attempting to deploy the clip, a knot was observed on the lock line and difficulty removing the lock line occurred.The lock line became stuck after removing 70% of the lock line.The clip delivery system was removed over the lock line, allowing for the lock line to be pulled out from the patient.The clip was successfully deployed, reducing the mr to grade 1-2.There was no clinically significant delay in the procedure.No additional information was provided.
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