The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. The reported patient effect of mitral valve injury (tissue damage), as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures. Based on the information reviewed, the tissue damage was reported to be due to the fragile leaflets and therefore related to patient morphology/pathology. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
This is filed to report tissue damage. It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr), with an mr grade of 4. Echo imaging was challenging. Two clips were implanted reducing mr to 2. To further reduce mr, a third clip (9113u259) was advanced to the mitral valve and the leaflets were grasped. When preparing to remove the lock line, it was noticed that mr increased to 2-3. The lock lever cap was placed back on, securing the lock line in place, unlocking, and removing the clip. A leaflet tear was suspected, due to the fragile leaflets. Another clip, was advanced, but leaflet capture was not successful due to short posterior leaflet and deteriorating echo image. The clip was not implanted and was removed. A total of two clips were implanted, reducing mr to 3. The patient was converted to open heart surgery for mitral replacement. The patient remained stable. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5