As reported by an edwards affiliate in (b)(4), during a transfemoral tavr, a frozen leaflet was observed post valve deployment.A 23mm sapien 3 valve was deployed with -1ml contrast solution than nominal volume due to narrow st junction.Then the balloon was moved to the left ventricular (lv) side and post-dilation was performed with nominal volume.Tee showed a central leak, the aortic regurgitation was determined moderate.The guidewire was removed from the lv but the condition did not change.Further examination revealed that one of the leaflets was pulled into the lv during the diastolic phase.Color doppler showed the ¿drop¿ area coincided with the central leak.The physician determined that it was an aortic insufficiency (ai) caused by ¿frozen leaflet¿ and a valve-in-valve was performed.The physician speculated that the leaflet might have been caught by the delivery system balloon during the post-dilation but the exact cause was unknown.
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The valve remains implanted in the patient; therefore, it cannot be returned for evaluation.No device photographs, videos or imagery relevant to the reported events were provided with the complaint.A device history review (dhr) was performed and the relevant work orders did not reveal any manufacturing non-conformance issues that would have contributed to the complaint events.A lot history review did not reveal any additional complaints related to ¿valve ¿ regurgitation-central leak¿, ¿leaflet ¿ motion restricted ¿ in patient¿ or ¿leaflet ¿ inadequate coaptation-in patient¿.A review of complaint history revealed that the complaint occurrence rates did not exceed the july 2018 control limits for trend categories ¿leaflet motion restricted (in patient)¿ and ¿regurgitation¿.No instructions for use (ifu) or training deficiencies were identified.Manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.Due to the device and/or relevant imagery/video not being returned for evaluation, the complaints for ¿leaflet ¿ motion restricted-in patient¿ and ¿valve ¿ regurgitation-central leak¿ were unable to be confirmed.A review of the dhr, lot history, and complaint history revealed no indication that a manufacturing non-conformance contributed to the complaint.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is unlikely that a manufacturing defect or device malfunction contributed to the events.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.There are several potential patient and procedural factors that alone or in combination can contribute to a report of a restricted or nonfunctioning leaflet.Based on historical review of complaints, these events are typically a result of native leaflet overhang due to ventricular valve movement post deployment, leaflet damage due to post-dilatation, leaflet impingement in a calcified valve, or slow recovery of adequate ventricular flow post valve deployment and rapid pacing.This can result in a temporary decrease in the pressure gradient between the ventricle and the aorta, resulting in an inadequate pressure change to close the leaflets.In many instances, this can be overcome with trouble shooting, which includes blood pressure recovery or support.As the native valve was moderately calcified, it is possible a thv leaflet was impinged by calcification resulting in a central leak.Per the ifu, valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve implant (tavi) procedure.The aforementioned patient and/or procedural factors can all contribute to suboptimal coaptation of the sapien 3 valve leaflets and cause central aortic regurgitation.As reported, after the initial deployment, ¿the balloon was moved to the left ventricular (lv) side and post-dilation was performed with nominal volume.¿ additionally, ¿the physician speculated that the leaflet might have been caught by the delivery system balloon during the post-dilation.¿ training materials state, ¿risks of post-dilatation include central ar.¿ therefore, the leaflet could have been damaged during the post dilatation process, resulting into central ar.It was noted that the ¿valve was deployed with -1ml contrast solution than nominal volume due to narrow st junction¿.Per training manual, a narrow stj leading to thv ventricular movement can affect the characteristics of a deployed thv.Although it unable to be confirmed without imagery, the valve may have migrated into the left ventricular due to the narrow stj during post dilatation, resulting in native leaflet overhang, and subsequently cause central ar.Available information suggests that patient (calcified native valve/narrow stj) and/or procedural (post dilation) factors may have contributed to the complaint events.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 complaints for ¿leaflet ¿ motion restricted-in patient¿ and ¿valve ¿ regurgitationcentral leak¿ were unable to be confirmed.Available information suggested that patient (calcified native valve/narrow stj) and/or procedural (post dilation) factors may have contributed to the complaint events.Since no manufacturing non-conformances were identified, no labeling or ifu/training inadequacies were identified, and review of the complaint history revealed that the occurrence rate did not exceed the (b)(6) 2018 control limit for the applicable trend category, neither a pra nor corrective or preventative action was required.
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