(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
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On (b)(6) 2009, this (b)(6) study patient underwent an aortic valve replacement and this 25 mm sjm trifecta valve was implanted.In (b)(6) 2016, the patient presented with severe ai.Echo revealed one leaflet appeared stiffened which may have prevented complete coaptation of the leaflets.Per report, leaflet thickening or pannus may have contributed to the severe ai.On (b)(6) 2016, a valve-in-valve procedure was performed successfully with a tavi valve from another manufacturer.The patient was reported to be recovering and doing well and discharged on (b)(6) 2016.((b)(6)).
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