The product was not returned; therefore, a no product return investigation was completed.As a device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.Review of the work orders above did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed using the valve serial numbers from related work order and revealed no other complaints relating to the relevant complaint codes.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The commander delivery system with s3/ s3u ifu was reviewed.Valve stenosis is a known potential adverse event.Noted under potential adverse events, 'valve stenosis.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 was confirmed from medical record.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.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 highly unlikely that a manufacturing defect or device malfunction contributed to the event.Per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.Per the valve academic research consortium (varc), valve stenosis can result from several factors, including calcification, support structure deformation (out-of-round configuration), trauma (cardio-pulmonary resuscitation, blunt chest trauma), and native leaflet prolapse impeding prosthetic leaflet motion.Similarly, pannus or host-fibrotic tissue growth overtime, a cause of nonstructural dysfunction, may interfere with the functionality of the device leading to valve stenosis.Stenosis of an implanted valve may be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.Svd may be mild and not require any intervention or it may be moderate to severe.It can cause the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.As reported, '1 year, 2 months post-implant of a 29 mm sapien 3 valve in the valve-in-valve mitral position, both valves required explant.The reason for explant was stated in the medical records as mitral stenosis and lvot obstruction'.Due to limited information, a definitive root cause was unable to be determined at this time.Since no device problem was identified affecting distributed product, no pra or capas are required.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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