MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number	ONXACE-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/08/2024
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- formerly cryolife/jotec is accurate or has been confirmed by artivion.
Event or Problem Description
According to the initial report, "received an aortic implant registration card for a patient with an existing aortic implant." implant date (b)(6) 2022.Explant date (b)(6) 2024.
Additional Manufacturer Narrative
The manufacturing records 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.On (b)(6) 2024 an artivion employee in device tracking was notified on an implant for a patient with a previously registered aortic valve implant and an investigation was started.This investigation is regarding an onxace-23 implanted (b)(6) 2022 in a 46-year-old male.On (b)(6) 2024 an onxace-23 was explanted and an onxace-21 was implanted.According to information provided by the surgeon the valve was explanted for severe paravalvular aortic regurgitation due to two perivalvular jets and the new valve appears to be working well.The valve was not returned for inspection and no medical records were provided.The instructions for use for the on-x valve acknowledge paravalvular leak as a potential complication following prosthetic valve replacement, which may lead to reoperation as well as explantation [ifu].Historically, major paravalvular leak occurs at a rate of (b)(4) per patient-year for rigid heart substitutes [iso 5840-2:2021(e)].The surgeon identified pvl as the root cause necessitating the explant; however, the limited information available and absence of medical records hinder a definitive conclusion regarding the underlying cause of the pvl.The most common causes of pvl are suture dehiscence, annular calcification and/or friability, infection, and technical issues during surgery.Given the available information, it remains unclear what, if any, contribution the valve itself had to the development of the pvl that led to the explant.The risk management and usability engineering file was reviewed and found to be adequate.Given the available information, it remains unclear what, if any, contribution the valve itself had to the development of the pvl that led to the explant; thus, severity and occurrence is not evaluated.The reported event will continue to be monitored for trends.No updates to the rmf are needed in response to this complaint.Risk has been reduced as low as possible and overall residual risk is acceptable.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 PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• 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: 20570479
• Report Number: 1649833-2024-00054
• Device Sequence Number: 12892011
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 00851788001464
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2022
• 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: 48 YR
• Patient Sex: Male