MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X MITRAL VALVE UNKNOWN CONFIGURATION; HEART VALVE, MECHANICAL

Model Number ONXM UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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 artivion is accurate or has been confirmed by artivion.

Event Description

This patient had post-op echo which indicated a functioning on-x mitral valve with a grade 1 valvular regurgitation (functioning wnl).The surgeon shared that the mitral annulus was very calcified and was debrided as was possible.The patient¿s daughter reports that at a later time (undetermined length of time) the patient¿s valve pulled apart/away leading to an eventual grade 3 to 4 leak.The patient¿s daughter also reported a possible endocarditis.In this case it is speculated to be potentially an endocarditis or calcific process leading to a major pvl, ultimately ending with this patient death.This incident was not initiated as a complaint by this patient¿s daughter, but her call was for information only regarding what she described as the normal leakage of the on-x mitral valve.

Manufacturer Narrative

According to the initial notification, "this patient¿s daughter was directed to me via phone call this morning.Her mother received an on-x conform-x mitral valve recently (date of implant not obtained).Information from pt¿s daughter (adult female) as the source for this report.This patient had post-op echo which indicated a functioning on-x mitral valve with a grade 1 valvular regurgitation (functioning wnl).The surgeon shared that the mitral annulus was very calcified and was debrided as was possible.The daughter reports that at a later time (undetermined length of time) the patient¿s valve pulled apart/away leading to an eventual grade 3 to 4 leak.I interpreted this description to indicate a valvular dehiscence from the pt mitral annulus leading to a perivalvular leak (pvl).The daughter also reported a possible endocarditis while we were discussing the situation.In this case it seems to be potentially an endocarditis or calcific process leading to a major pvl.Ultimately ending with this patient death.On (b)(6) 2024: additional information received via phone conversation with patient's daughter: "this event took place 4 years ago.The patient ultimately passed due to infective endocarditis.The surgeon stated at an unknown time that calcification was present, and there was not an intervention performed to specifically address it.With the increased regurgitation levels, a plug was placed during another surgery.Now if the higher regurgitation levels, say 4 to 5 were taken after the plug is unknown.Ana stated that the endocarditis was not ¿noticed¿ soon enough so her mother went into sepsis." no additional information forthcoming.A review of manufacturing records could not be completed, as the lot number was unknown.The available information was reviewed.On (b)(6) 2024, an artivion employee spoke with the adult daughter of a patient and the following information was relayed ; ¿her mother received an on-x conform-x mitral valve recently (date of implant not obtained).This patient had post-op echo which indicated a functioning on-x mitral valve with a grade 1 valvular regurgitation (functioning wnl).The surgeon shared that the mitral annulus was very calcified and was debrided as was possible.Ana reports that at a later time (undetermined length of time) the patient¿s valve pulled apart/away leading to an eventual grade 3 to 4 leak.I interpreted this description to indicate a valvular dehiscence from the pt mitral annulus leading to a perivalvular leak (pvl).Ana also reported a possible endocarditis while we were discussing the situation.In this case it seems to be potentially an endocarditis or calcific process leading to a major pvl.Ultimately ending with this patient death." a field assurance investigation was started additional information obtained as follows: "this event took place 4 years ago.The patient ultimately passed due to infective endocarditis.The surgeon stated at an unknown time that calcification was present, and there was not an intervention performed to specifically address it.With the increased regurgitation levels, a plug was placed during another surgery.Now if the higher regurgitation levels, say 4 to 5 were taken after the plug is unknown.Ana stated that the endocarditis was not ¿noticed¿ soon enough so her mother went into sepsis." we do not have the date of implant or sn and were provided two pages of medical records that were in spanish with results from an echocardiogram performed on an unknown date.Once translated the conclusion on the echo report was ¿mechanical prosthesis in mitral position with transvalvular gradients within normality and no evidence of significant pathological leak.¿ with the information provided by the daughter we cannot conclude that the cause of the patient¿s death was linked to the mitral valve, the pvl and/or endocarditis.If the patient suffered from endocarditis, it is likely that the root cause of the pvl is valvular dehiscence from friable tissue around the annulus caused by endocarditis.In addition, with the information available, the source of the endocarditis is also unknown.However, because the on-x valve manufacturing process includes validated terminal sterilization prior to distribution the valve is unlikely to be the source of infection.The instructions for use (ifu) for the on-x valve states that reoperation and death may result from a complication, in this case, endocarditis, a known potential event acknowledged in the ifu.Though rare, historically, endocarditis occurs at a rate of (b)(4) patient-year for mechanical mitral heart valves [iso 5840-2:2021].With the limited information provided we are unable to conclude that the cause of the patient¿s death is linked to the mitral valve, the pvl and/or endocarditis.If the patient suffered from endocarditis, it is likely that the root cause of the pvl is valvular dehiscence from the friable tissue around the annulus caused by endocarditis.However, because the on-x valve manufacturing process includes validated terminal sterilization prior to distribution the valve is unlikely to be the source of infection.No further action is required without additional information.A review of the information was performed to compile a risk analysis.With the limited information provided we are unable to conclude that the cause of the patient¿s death is linked to the mitral valve, the pvl and/or endocarditis.If the patient suffered from endocarditis, it is likely that the root cause of the pvl is valvular dehiscence from the friable tissue around the annulus caused by endocarditis.However, because the on-x valve manufacturing process includes validated terminal sterilization prior to distribution the valve is unlikely to be the source of infection.A product failure mode cannot be identified; thus, severity and occurrence is not evaluated.There is no indication that an error or deficiency occurred at artivion formerly cryolife and all risks identified have been mitigated as far as possible and residual risk is acceptable.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are 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 artivion is accurate or has been confirmed by artivion.

Manufacturer Narrative

02/07/2024: additional information received via phone conversation with patient's daughter: "this event took place 4 years ago.The patient ultimately passed due to infective endocarditis.The surgeon stated at an unknown time that calcification was present, and there was not an intervention performed to specifically address it.With the increased regurgitation levels, a plug was placed during another surgery.Now if the higher regurgitation levels, say 4 to 5 were taken after the plug is unknown.Ana stated that the endocarditis was not ¿noticed¿ soon enough so her mother went into sepsis." this investigation is currently ongoing.Any additional information will be provided in the follow-up report.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 artivion is accurate or has been confirmed by artivion.

• Brand Name: ON-X MITRAL VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; building b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; building b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard, nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18606359
• MDR Text Key: 334097228
• Report Number: 1649833-2024-00016
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXM UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death