This is filed to report the septum injury.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.The heart was enlarged, and the posterior leaflet was tethered.Imaging was challenging due to the echocardiogram equipment being old.The first clip was implanted without issue.To further reduce mr, a second mitraclip delivery system (cds) was advanced.Grasping the leaflets was unsuccessful, the leaflets would not remain captured.When attempting to reposition the clip, the clip got caught on chordae.The clip was inverted, the knobs were put on neutral and the clip was freed from chordae without causing injury.At this time, it was also observed that the steerable guide catheter (sgc) tore the septum.A closure device was implanted to treat the septum.A total of one clip was implanted, reducing mr to 3-4.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 this event.The reported patient effect of perforation as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.Based on available information, a cause of the reported perforation could not be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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