This is filed to report difficult to close, single leaflet device attachment and gripper line break.It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.It was noted the valve had barlow¿s disease, posterior prolapse and flail, large atrium, and annulus dilatation.An xtw clip was inserted and placed at a2/p2 to treat the p2 prolapse and flail.It was observed that due to patient anatomy, the clip was unable to close to 20 degrees.Establishing final arm angle (efaa) was successfully performed.However, it observed in fluoroscopy that a little thread was pointing out of the device.It was assumed this thread was a broken gripper line.Since the anterior leaflet was captured by the gripper, the physician decided to deploy the clip.Shortly after deployment, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).To stabilize the clip, two additional clips were implanted, reducing mr to a grade of <1.There was no clinically significant delay in the procedure.No additional information was provided.
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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 the reported event.A review of the complaint history identified no other complaints from the lot.Based on the information reviewed and without the device to analyze, a cause for the reported gripper line break cannot be determined.The reported unable to close the clip resulting in single leaflet device attachment (slda) appears to be related to patient conditions.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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