Attempts to obtain additional information regarding the reported event were unsuccessful and included phone calls on 10/17/2016, 10/19/2016, and 10/20/2016 as well as a letter on 10/20/2016.Should additional information become available it will be evaluated and the complaint will be reopened.The manufacturing records for the onxace-23, sn (b)(4), were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The onxace-23, sn (b)(4), was implanted (b)(6) 2014 and replaced with another onxace-23 on (b)(6) 2016 by the same surgeon.Information received came from irc and contained no other details.There is no information available to indicate reason for explant and whether or not there is any relationship to the valve.However, reoperation and explant are listed in the instructions for use (ifu) as recognized risks associated with aortic valve replacement.A root cause cannot be determined for the reported event.The on-x 614 heart valve design fmea thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.A root cause for the reported event is unavailable.However, the ifu lists adverse events potentially leading to the reoperation and explant of a prosthetic heart valve.This event does not identify additional hazards or modify the probability and severity of existing hazards.
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