Edwards received notification from our affiliate in (b)(6).As reported, this was an implant of a 26mm sapien 3 ultra valve, by transfemoral approach.During commander delivery system preparation, no issues were observed.During valve deployment, incomplete expansion of the valve was observed.A new commander delivery system was used for complete expansion of the valve with perfect results and no consequence for the patient.After the procedure, it was a balloon pinhole leak was observed on the balloon.
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The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this event.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 provided video by the site showed the delivery system after use.During the inflation of the balloon, a leak can be noted on the proximal portion of the inflation balloon.The complaint of balloon leak was confirmed per imagery provided.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.Additionally, a review of the dhr, lot history and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Per the complaint description, 'during the commander delivery system preparation no issues were observed.During the deployment phase, an incomplete expansion of the valve was observed with totally inflation of the inflation device'.Also, during the inflation, it was noted a leak, after procedure a balloon pinhole was observed'.The delivery system was able to be de aired when prepping', which suggests a balloon was damaged after deployment.Patient information was not provided it is possible that the interaction with calcification during the valve deployment balloon was punctured and leaked.Available information suggests that patient factors (calcification) may have contributed to the complaint events.However, a definitive root cause was unable to be determined.Since no product non-conformances, labeling or ifu/training manual deficiencies were identified, neither corrective/preventative actions nor product risk assessment (pra) are required at this time.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.
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