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, a 76 year old male, by protocol, the patient is the recipient of an onxan or onxane model on-x valve in the aortic position.Postoperatively, he was in sinus rhythm and nyha iii.He had no prior cardiac surgery but at this one he also had coronary artery bypass graft.Sometime after the on-x valve surgery, he was the recipient of a permanent pacemaker (ppm), and since the observational window is 14 days postoperatively, it would be classified as a major adverse valve-related event per the aats/sts (american association for thoracic surgery/society of thoracic surgeons) criteria [akins 2008].No other information is available after this observation and so we have no further indications supporting the decision to implant the ppm.In any case, the instructions for use recognize arrhythmia and the possibility of subsequent reoperation as potential adverse events following aortic valve replacement [ifu].References: akins cw, et al.Guidelines for reporting mortality and morbidity after cardiac valve interventions, j thorac cardiovasc surg 2008; 135: 732-738.On-x instructions for use including aortic valve inr 1.5-2.0 update.Http//www.Onxlti.Com/ifu.Arrhythmia and reoperation are recognized potential complications following aortic valve replacement surgery, but there is not enough detailed information to establish a root cause.However, per aats/sts guidelines, this is classified as a major valve-related adverse event.No further action is required at this time.The cause of ppm implant is unknown.The ifu provides instruction about the potential adverse events associated with the use of prosthetic heart valves which may lead to explantation, reoperation, disability, or death.The on-x heart valve risk management file 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.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.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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