A review of the available information of the on-x prosthetic heart valve anatomic suture ring post-market study was performed.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 (b)(6)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.As reported in the post-market study, the patient is a 53 year old white female.By protocol, she is 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.Within 14 days postoperatively, she is reported to have experienced a minor cardiac bleeding event.No other information is available following this observation as the protocol limits adverse event reporting to 14 days postop.We have no additional information on the nature of the bleed; neither its source nor its outcome.Consequently, there is not enough information to say what, if any, relationship this event has to the valve.Nevertheless, the instructions for use lists bleeding as a potential complication following aortic valve replacement [ifu].Bleeding is a known potential complication following aortic valve replacement surgery, but information describing a suspected source of the bleed is not provided and so we do not have enough information to know what, if any, relationship it has to the 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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