The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
This is filed for clip caught in the chordae, requiring surgical intervention. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The clip delivery system (cds) was prepared for use and no issues were noted. The cds was advanced into the patient anatomy. The clip arms were opened to position over the valve. The clip arms were then closed and the cds was advanced below the valve. An attempt was made to open the clip arms, but the clip would not open. Standard troubleshooting was performed and the clip opened. The clip was able to grasp the leaflets; however, the decision was made to re-grasp at another leaflet location. The clip would not open and standard troubleshooting was performed. The clip opened, but became caught in the chordae. It was noted that the lock line was disconnected inside the clip delivery system handle. Troubleshooting was performed; however, the clip could not be removed from the chordae and the decision was made to deploy the clip where it was caught. The clip was deployed on the chordae only. The patient was then sent to surgery for a mitral valve replacement procedure. Post surgical procedure, the patient was in stable condition. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5