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

Model Number	ONXAAP-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Insufficient Information (4580)
Date of Event	06/24/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
According to the initial report, "received an aortic implant registration sn (b)(6) onxaap-23 for a patient with an existing aortic implant.Please notify me if this is actually an explant.
Additional Manufacturer Narrative
The manufacturing records for onxmc-25/33 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.An onxaap-23 serial number: (b)(6) was implanted on (b)(6) 2020 in a 58 year old female and 1,102 days post-implant it was explanted and replaced with another onxaap-23.Information from the surgeon indicated that the valve had been removed due to endocarditis and that the patient was doing fine.The explanted valve was not returned to the manufacturer for examination.No further information was provided, and no medical records were available for review.A review of the original manufacturing records shows no abnormalities.With the information provided, the source of the endocarditis is unknown.However, because all on x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the 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)(6) / patient-year for mechanical aortic heart valves [iso 5840-2:2021].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, "received an aortic implant registration sn: (b)(6) onxaap-23 for a patient with an existing aortic implant.Please notify me if this is actually an explant.".

• Brand Name: ONX ASCENDING AORTIC 23
• Common Device Name: 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., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17505447
• Report Number: 1649833-2023-00028
• Device Sequence Number: 6149736
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 851788001525
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 03/01/2022
• Device Model Number: ONXAAP-23
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2017
• 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: 60 YR
• Patient Sex: Unknown