Note: (b)(6).Additional information received from the nurse stated that the indication for re-intervention/explant was ¿dehiscence of the aortic root¿ but an etiology was not specified.The procedure was successfully completed but no other details were provided.The manufacturing records for the onxaap-27/29, 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.A review of the available information was performed.The onxaap-27/29, sn (b)(4), was implanted (b)(6) 2014 and explanted/replaced with another onxaap-27/29 on (b)(6) 2016 (2 years 89 days postop).Reports from the explanting site state the reasons for explant were "revision/upgrade" and "dehiscence of the aortic root." the first reason doesn't tell us anything useful but the second suggests that the valve cuff was separating from the aortic annular tissue.How this was diagnosed or what symptoms led to the decision to replace, actual location of the separation and its severity, are not given, nor is there any indication of the precipitating cause of the separation.No mention is made of tissue viability or of suture/cuff integrity.The replacement procedure, nevertheless, was successfully completed.There is not enough detailed information to indicate what, if any, relationship the dehiscence has to the valve.The precipitating cause, in particular, remains unknown.This event does not identify additional hazards or modify the probability and severity of existing hazards.
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