It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.During preparation, while unpacking the clip out of the box, a mitraclip xt was observed to be inverted.The clip was prepped without issues and was inserted.However, after deployment, the clip opened from closed to greater than 10 degrees.It was noted that the clip remained stable on the leaflets.An additional clip was deployed, 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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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 clip open while locked and no apparent adverse event (inverted clip during unpacking) were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Imaging review: one (1) fluoroscopic still image was provided.In the image, two fully deployed clips can be visualized indicating the image was taken post deployment of the second clip (no reported issue).The two clips are overlayed in the image such that the clip arms of each clip can be discerned based on the relative location of the threaded studs.One clip appears to have an arm angle of ~35° (reported device) and the other clip ~25° (second clip, no reported issue).Presumably, the clip with the larger observed clip arm angle is the first implanted clip reported for post deployment cowl.While the angles stated in this evaluation are estimations based on visual assessment with the naked eye and are not confirmed, the estimated arm angle of ~35° for the reported clip is near the high end of the typical range of clips implanted per the instructions for use (10 - 30°).This suggests a potential change in arm angle.However, no pre-deployment cine of the reported clip was provided; as such, no assessment or comment can be made regarding the pre-deployment state of the clip (clip arm angle prior to dc detachment), if and/or by how much the clip opened prior to mechanical separation.There are no other observations based on the image provided.
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