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

Model Number	ONXANE-23
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
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, an aortic eirc was received for a patient with an existing aortic valve.Additional information was received indicating this device was explanted due to paravalvular leak.This device was discarded at the facility.The current status of this patient is currently unknown.
Event or Problem Description
According to the initial report, an aortic eirc was received for a patient with an existing aortic valve.Additional information was received indicating this device was explanted due to paravalvular leak.This device was discarded at the facility.The current status of this patient is currently unknown.
Additional Manufacturer Narrative
The manufacturing records for onxane-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.On (b)(6) 2023 an artivion employee was notified on an explant of an aortic mechanical valve.This complaint is regarding onxane ¿ 23 sn (b)(6) implanted on (b)(6) 2022 in a 50 year old male.On (b)(6) 2022 onxane 23 sn (b)(6) was implanted and on (b)(6) 2023 it was explanted and replaced with onxane 21 sn (b)(6) (516 days post implant).During communication with the hospital, we received the following information : that the patient is no longer in the hospital, so a current status is not available and according to a chart review the valve was replaced for a paravalvular leak.In addition, the valve is no longer available for return and no medical records or further information will be 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 0.3% per patient-year for rigid heart substitutes [iso 5840-2:2021(e)].With the information that a pvl [paravalvular leak] was identified by the hospital as the reason for explant and as the usual cause of pvl is related to surgical technique, we can conclude that there was no issue with the valve, and it did not contribute to the decision to explant.No further action necessary without further information.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: ONX AORTIC ANATOMIC EXT 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 boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17783535
• Report Number: 1649833-2023-00033
• Device Sequence Number: 6059734
• Product Code: LWQ
• UDI-Device Identifier: 00851788001662
• UDI-Public: 851788001662
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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 Model Number: ONXANE-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: 08/22/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male