The event is captured by edwards lifesciences under complaint #: (b)(4).Based on the image evaluation findings this device was also contributory to the event- leading to high residual tr.The device was removed.This mdr is linked to a previous one under mfr report number 2015691-2023-15051 which is for the same patient.Also, this is an initial + final combined mdr report.The complaint for reduced therapeutic efficacy over time / incorrect implant position was confirmed with objective evidence.No manufacturing non-conformities were identified from the imaging evaluation.Based on the imaging evaluation, residual tr post-procedure is semi-quantitatively severe after the implantation of two pascal ace devices with an untreated central valve regurgitation.Possible contributing factors to the high residual tr include procedural related issues and positioning of the ace devices leaving the largest central tr jet untreated.Available information suggests that patient conditions including a large flail segment may have contributed to the reported event.It should be noted, the device was implanted in the tricuspid position.At this time, the pascal precision transcatheter valve repair system is only indicated for the native mitral valve, addressing degenerative mitral regurgitation.Therefore, deployment in the tricuspid position is considered off-label.
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