A review was performed of the available information of the on-x prosthetic heart valve anatomic suture ring post-market study.The purpose of the study is to assess the rate of occurrence of permanent pacemaker implantation within 14 days of surgery with on-x prosthetic heart valve with anatomic sewing ring when used to replace diseased aortic valves in human subjects through the use of a retrospective registry.The protocol for this study is as follows: this study is multicenter and retrospective.All centers will follow a common protocol in which eligible patients will be entered into the registry after the 14th postoperative day.No procedures will be done and only retrospective data covering the preoperative, operative and the first 2 weeks postop will be collected.The valve safety primary endpoint is "occurrence of permanent pacemaker implantation within 14 days of surgery as a valve-related adverse event per the definitions of the american association for thoracic surgery/society of thoracic surgeons (aats/sts) guidelines." the valve safety secondary endpoint is "occurrence of other valve-related adverse events within 14 days of surgery per the definitions of the aats/sts guidelines." per the information available to us, this study began in 2013.The study was closed out 04/30/2018 and we are now becoming aware of the primary and secondary endpoints reported by all of the centers.For each event, the date of implant, date of event, and valve-identifying information is unknown.Patient 12 is described as a 26 year old female of american indian/native alaskan ethnicity.By protocol, she would be the recipient of an onxan or onxane model on-x valve in the aortic position.She was in sinus rhythm preoperatively with no prior history of cardiac surgery reported.Postoperatively, she was diagnosed with valve thrombosis, but no inr at the time of the event was provided.No other information is available after this observation, including an outcome, as the protocol limits adverse event reporting to 14 days postop.Objective performance criteria report an historical thrombosis incidence of 0.8% per valve-year for all rigid prosthetic valves.The instructions for use list thrombosis as a recognized potential complication following aortic valve replacement surgery, but we do not have enough information to know what, if any, relationship this particular diagnosis has to the on-x valve.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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