As reported in the on-x prosthetic heart valve anatomic suture ring post-market study, this patient experienced congestive heart failure, reoperation and death.This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and (b)(6) 2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.
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A review of the available information 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 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, this study patient, hospital universitari germans trias i pujol (hug), experienced congestive heart failure and death.The patient (as part of the on-x prosthetic heart valve anatomic suture ring postmarket registry), is a 63 year old male, degenerative calcific disease etiology, nyha iv, stenotic lesions, with a history of atrial fibrillation and surgical treatment of sinus of valsalva aneurysm (sva) in 07/01/2002 and 11/02/2007.By protocol, they are the recipient of an onxan or onxane model on-x valve in the aortic position.Postoperatively, the patient developed congestive heart failure (chf), underwent reoperation, and subsequently died.Crfs indicated 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.A pacer was not implanted non valve related chf in this case would most likely be related to comorbid conditions associated with multiple svas - although this cannot definitively be confirmed.There is no indication that the on-x valve contributed to the event.Although relatively rare, death is a recognized potential adverse event associated with heart valve replacement [instructions for use].Definitive root cause for the reported event is unknown.There is not enough information to indicate a cause for the chf noted to be non-valve related.There is no indication that the on-x valve contributed to the event.No further action is required at this time.
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As reported in the on-x prosthetic heart valve anatomic suture ring post-market study, this patient experienced congestive heart failure, reoperation and death.This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and (b)(6) 2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.
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