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 incidents reported from this lot.Based on the available information, the reported expulsion (complete clip detachment) appears to have been a result of challenging patient anatomy.The reported patient effects of heart failure, dyspnea, recurrent mitral regurgitation (mr) and foreign body in patient appear to have been cascading events of the reported expulsion (complete clip detachment).A cause for the reported poor imaging could not be determined.Additionally, the reported patient effects of heart failure, dyspnea, recurrent mr, and foreign body in patient as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional devices referenced are filed under separate medwatch report numbers.
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This is being filed to report the clip completely detached from both leaflets.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.Although imaging was difficult, one clip was successfully placed at a2p2.A second clip delivery system (cds) was advanced medial to the first clip.During grasping, it was noted the first clip had detached from the anterior leaflet (single leaflet device attachment (slda)).The second clip was deployed to stabilize the slda clip, reducing mr to 2.Per the physician, the slda was due to friable leaflets and difficult imaging.Approximately two weeks after the procedure was performed on (b)(6) 2020, the patient was readmitted for worsening heart failure and was experiencing dyspnea.X-ray was performed where it was noted the slda clip was no longer on the valve.The clip had completely detached and was in the hepatic vein.Additionally, the second clip implanted on (b)(6) 2020, could not be seen on the valve either.The mr had increased to 4.No additional information was provided.
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