MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL

Model Number	ONXACE-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report an aortic implant registration card was received for a onxace-21 that is for a patient with an existing aortic implant.The onxace-21 sn: (b)(6) was implanted on (b)(6) 2023.It was then explanted on (b)(6) 2023.Additional information provided from the surgeon is as follows "i explanted the valve so i could do a redo avr/mvr for mitral valve endocarditis (culture negative).I put another on-x back in the aortic position and put an on-x mechanical in the mitral.The old dehisced valve was a st.Jude.There was nothing wrong with the on-x aortic valve.I just took it out for exposure purposes and i could not say that it was not infected.It looked perfect and it was functioning perfectly too.Valve was not saved.Patient is doing great." no additional information forthcoming.
Additional 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.
Additional Manufacturer Narrative
The manufacturing records for the onxace-21 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.During the investigation no non-conformances or deviations were noted.Change order(s) for leaflet tuning are performed as a part of the standard manufacturing process.On (b)(6) 2023 an onxace-21 sn (b)(6) was used in a case for a 63-year-old female in the aortic position.A second aortic on-x was reported to device tracking on (b)(6) 2023 as implanted in the same position, same patient: (b)(6) 2023 onxace-21 sn (b)(6) (150 days post-implant).Additional information was obtained from the surgeon; however, the valve was not returned for inspection.The statement from the surgeon is as follows "i explanted the valve so i could do a redo avr/mvr for mitral valve endocarditis (culture negative).I put another on-x back in the aortic position and put an on-x mechanical in the mitral.The old dehisced valve was a st.Jude.There was nothing wrong with the on-x aortic valve.I just took it out for exposure purposes, and i could not say that it was not infected.It looked perfect and it was functioning perfectly too.Valve was not saved.Patient is doing great." review of manufacturing records show no processing issues with the original valve and with the statement from the surgeon we can say that the on-x aortic valve itself did not contribute to the explantation.The valve was explanted during an avr/mvr redo secondary to mitral valve endocarditis and the surgeon could not definitively state there was no infection of the aortic valve when it was removed to facilitate the replacement of the infected mitral valve.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 or Problem Description
According to the initial report an aortic implant registration card was received for a onxace-21 that is for a patient with an existing aortic implant.The onxace-21 sn: (b)(6) was implanted on (b)(6) 2023.It was then explanted on (b)(6) 2023.Additional information provided from the surgeon is as follows "i explanted the valve so i could do a redo avr/mvr for mitral valve endocarditis (culture negative).I put another on-x back in the aortic position and put an on-x mechanical in the mitral.The old dehisced valve was a st.Jude.There was nothing wrong with the on-x aortic valve.I just took it out for exposure purposes and i could not say that it was not infected.It looked perfect and it was functioning perfectly too.Valve was not saved.Patient is doing great." no additional information forthcoming.

• Brand Name: ONX AORTIC CONFORM EXT 21
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17558987
• Report Number: 1649833-2023-00029
• Device Sequence Number: 3435101
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 851788001457
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female