MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXACE-23

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

Patient Problems Endocarditis (1834); Stenosis (2263)

Event Date 11/16/2023

Event Type  Injury  

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

According to the initial notification received via on 19jan2024, onxace-23 was explanted on (b)(6) 2023.Receipt of additional information from the surgeon: the on-x explant was for infection unrelated to the valve.Information from the operative notes: implant of on-x ace 23 performed on (b)(6) 2021 due to prosthetic valve stenosis and insufficiency.The on-x ace 23 was explanted on (b)(6) 2023 due to aortic valve dehiscence.Suspected endocarditis, and all cultures have been negative.

Manufacturer Narrative

The manufacturing records for onxace 23 sn (b)(6) were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.Document change orders (b)(4) and (b)(4) was issued for leaflet tuning as a part of the standard manufacturing process.Onxace 23 sn (b)(6) was implanted (b)(6) 2021 in a 63-year-old female with an medical history of aortic valve replacement with trifecta tissue valve in 2014, chf, htn, dual chamber pacemaker and suspected endocarditis.A second aortic on-x was reported to device tracking as implanted in the same position, same patient : on (b)(6) 2023 onxane-25 sn (b)(6) ( 945 days post implant).Information from the surgeon indicated that the valve had been removed due to endocarditis unrelated to the valve.In the provided medical records: ¿ the valve had dehisced at the region of the noncoronary sinus with the pledgeted sutures intact on the sewing ring of the aortic valve, but they had torn through the aortic anulus.There seemed to be a healed abscess underneath the left main coronary artery which displaced the valve inferiorly into the lvot somewhat.The valve was resected and sent off to microbiology.In addition, we sent off samples from the aortic anulus pledgets that were sitting in the aortic anulus and any graft material that we removed from the aorta.After debriding the pannus and the aortic anulus of the pledgets, the tissue itself looked robust.There did not seem to be any active infection going on, and all this appears to be a healed endocarditis and a healed over abscess.¿ the final diagnosis was listed as: ¿suspected endocarditis may be healed infection, and all cultures have been negative¿.With the information available, the source of the endocarditis is unknown.However, because the on-x valve manufacturing process includes validated terminal sterilization prior to distribution¿verified by a review of manufacturing records unique to this valve¿the valve is unlikely to be the source of infection.The instructions for use (ifu) for the on-x valve states that reoperation, including explantation, 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 aortic heart valves (b)(4).Endocarditis is the root cause for the explantation of the aortic on-x valve.Because all on-x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the infection.With the information available, the source of the endocarditis is unknown.However, because the on-x valve manufacturing process includes validated terminal sterilization prior to distribution¿verified by a review of manufacturing records unique to this valve¿the valve is unlikely to be the source of infection.Receipt of additional information from the surgeon: the on-x explant was for infection unrelated to the valve.The instructions for use (ifu) for the on-x valve states that reoperation, including explantation, 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 aortic heart valves (b)(4).Endocarditis is the root cause for the explantation of the aortic on-x valve.Because all on-x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the infection.Receipt of additional information from the surgeon documents that the on-x explant was for infection unrelated to the valve.A product failure mode cannot be identified; thus, severity and occurrence is not evaluated.Endocarditis is the root cause for the explantation of the aortic on-x valve.Because all on-x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the infection.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.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.

Event Description

According to the initial notification received via email on (b)(6) 2024, onxace-23 was explanted on (b)(6) 2023*.Receipt of additional information from the surgeon: the on-x explant was for infection unrelated to the valve.Information from the operative notes: implant of on-x ace 23 performed on (b)(6) 2021 due to prosthetic valve stenosis and insufficiency.The on-x ace 23 was explanted on (b)(6) 2023 due to aortic valve dehiscence.Suspected endocarditis, and all cultures have been negative.See attachment titled: operative notes for details.The explant date was reported in error.The correct explant date is on (b)(6) 2023.No additional information forthcoming.This event is relegated to onxace-23 serial number: (b)(6).

• Brand Name: ONX AORTIC CONFORM EXT 23
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18608038
• MDR Text Key: 334109887
• Report Number: 1649833-2024-00017
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 00851788001464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 03/21/2024
• Date Device Manufactured: 01/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female