(b)(4).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 this event.Additionally, a review of the complaint history did not identify a lot specific quality issue.All available information was investigated and without the device to analyze, a definitive cause for the reported unintended movement (clip open ¿ efaa, clip open ¿ locked) could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other two mitraclip devices referenced are filed under a separate medwatch report number.
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This is filed to report the clip opened during the final arm angle test and after clip deployment.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.The first clip delivery system (cds 90926u451) was advanced to the mitral valve.The final arm angle (efaa) test failed, the clip opened to 50-60 degrees.The sixth efaa attempt was successful; however, the decision was made to not implant the clip and the cds was removed.A second cds (90926u452) was advanced and the clip was placed.However, during the efaa test the clip slightly opened 20-25 degrees.Leaflet insertion was still very good, therefore the clip was implanted.After deployment, the clip opened more than prior to deployment, but remained secure on the leaflets.A third clip (90926u496) was advanced to further reduce mr; after the leaflets were grasped, the posterior leaflet tore.The clip was implanted; mr was reduced to 3-4.The patient was hemodynamically stable and was extubated without any problems.No additional information was provided.
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