During a tavr procedure using a 26mm sapien 3 valve via transfemoral approach, during inflation of the commander balloon, the valve jumped into the aorta due to loss of pacing.The valve was pulled and implanted in the thoracic aorta.A second valve was implanted in aortic position.There was no consequence for patient.Patient demographics were not able to be obtained.The operators attested that this incident was not due to edwards device quality issue.No other information will be available for this event per reporter.
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The 26mm sapien 3 valve was not returned for evaluation.Without the return of the device for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u and procedural training manual.Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter valve replacement (thv) procedure.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint for valve embolization was unable to be confirmed as no imagery/medical record was provided for evaluation.There was no allegation or indication a device malfunction contributed to this adverse event.A review of ifu/training materials revealed no deficiencies.As reported, "during inflation of the commander balloon, the valve jumped into the aorta due to loss of pacing.The valve was pulled and implanted in the thoracic aorta".In this case, the loss of pacing capture could cause the valve to jump into the aorta.Per the training manual, loss of pacing capture during valve deployment could lead to "sudden movement during deployment" resulting in the valve embolized into the aorta as reported.Available information suggests that procedural factors (loss of pacing capture) may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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