This is being filed to report an atrial percutaneous intervention and a drop in oxygen saturation.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3+.Imaging was noted to be difficult due to shadowing.The clip delivery system (cds) was advanced and grasping was difficult due to patient anatomy, as there was a large coaptation gap.The clip was able to be implanted; however, after deployment, the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).An additional clip was implanted to stabilize the sdla clip.The mr was reduced to 2+.After the steerable guide catheter (sgc) was removed, an atrial septal defect (asd) was noted.An asd closure device was used for treatment; however, the patient was difficult to stabilize and the oxygen had dropped.The patient continued to be monitored and was extubated later.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.Based on available information, the cause of the reported perforation could not be determined.Moreover, the cause of the reported hypoxia could not be determined.The reported perforation as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was the 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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