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.The investigation was unable to determine a cause for the reported gripper actuation issue (posterior gripper was no functioning as intended).There is no indication of a product 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 (mr) with a grade of 4.A mitraclip xtw was inserted without issues.However, while in the valve, while testing the grippers, it was observed that the posterior gripper was not functioning as intended.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.While outside the patient, the clip was tested, and both of the grippers were working properly.The procedure was completed with one clip implanted, reducing the mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.
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