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

Model Number	ONXANE-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, this valve was implanted on (b)(6) 2022 and replaced on (b)(6) 2023 due to endocarditis.
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 onxane-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.Onxane 21 sn: (b)(6) was implanted on (b)(6) 2022 in a 58 year old female with a medical history of bicuspid aortic valve and ascending aortic aneurysm in a concomitant procedure with a hemi-arch repair with a 24mm graft.According to a report made by the surgeon through a sale representative, this valve was explanted on (b)(6) 2023 (284 days post-implant) and replaced with onxaap-21.Information from the surgeon indicated that the valve had been removed due to endocarditis.No medical records or operative notes were provided to the manufacturer and the explanted valve was not returned for examination.A review of the original manufacturing records shows no abnormalities.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 [iso 5840-2:2021].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 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, this valve was implanted on (b)(6) 2022 and replaced on (b)(6) 2023 due to endocarditis.

• Brand Name: ONX AORTIC ANATOMIC 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: 17197483
• Report Number: 1649833-2023-00016
• Device Sequence Number: 5683887
• Product Code: LWQ
• UDI-Device Identifier: 00851788001419
• UDI-Public: 851788001419
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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
• Device Expiration Date: 08/19/2019
• Device Model Number: ONXANE-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: 05/27/2023
• Supplement Date Received by Manufacturer: 05/27/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female