Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the valve did not have any evidence of impingement.Using a blue actuator to test leaflet movement, the leaflets moved without difficulty and both were intact with no evidence of damage.Both inflow and outflow valve hinge mechanisms were intact.The inflow and outflow orifices were intact with no evidence of damage.The valve was rinsed under tap water and it was verified that the carbon subassembly rotated in the sewing ring.If information is provided in the future, a supplemental report will be issued.
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