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 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.As reported in the post-market study, the patient, a 62 year old male, calcific disease etiology, nyha iv [new york heart association ¿ classification of heart failure], stenotic lesions, with prior cabg, by protocol are the recipient of an onxan or onxane model on-x valve in the aortic position.Postoperatively, the patient developed congestive heart failure (chf).Case report forms (crfs) indicate that the chf was not valve related.No other information is available following these observations as the protocol limits adverse event reporting to 14 days postop.It was noted that the patient did not receive a pacer postop.Non valve related chf would likely indicate an association with either cardiac muscle failure or conduction failure, but no definitive information is available.There is no indication that the on-x valve contributed to the event.The ifu [instructions for use] lists potential complications occurring with the use of the on-x valve.No further action is required at this time.The root cause of the event is unknown.The event is noted as non-valve related.The ifu provides instruction about the potential adverse events associated with the use of prosthetic heart valves which may lead to explantation, reoperation, permanent disability, or death.No action necessary.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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