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

Model Number ONXAAP-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 10/17/2023

Event Type  Injury  

Event Description

According to the medwatch report mw5148519 received via email on 12/18/2023 from the fda,"it was learned that a patient with a non-edwards 23mm on-x mechanical valve developed large lvot pseudoaneurysm approximately 1 year post implant and had extensive testing, but no clear etiology/mechanism for the mechanical valve failure and presumed culture negative endocarditis.She underwent redo bio bentall (b)(6) 2023) and the mechanical valve was replaced with a 25mm edwards aortic valved-conduit.This report reflects information received by fda in the form of a notification per 803.22 (b)(2)." additional information taken from the medwatch form indicated a on-x aap 23mm valve was explanted.

Manufacturer Narrative

According to the medwatch report mw5148519 received via email on 12/18/2023 from the fda,"it was learned that a patient with a non-edwards 23mm on-x mechanical valve developed large lvot pseudoaneurysm approximately 1 year post implant and had extensive testing, but no clear etiology/mechanism for the mechanical valve failure and presumed culture negative endocarditis.She underwent redo bio bentall (b)(6) 2023) and the mechanical valve was replaced with a 25mm edwards aortic valved-conduit.This report reflects information received by fda in the form of a notification per 803.22 (b)(2)." additional information taken from the medwatch form indicated a on-x aap 23mm valve was explanted.A review of the information was performed.A medwatch report was received via email on 18dec2023 regarding an explant of an 23mm on-x aortic mechanical valve, serial number unknown.According to the report approximately 1 year after implant in a patient of unknown gender and age the valve was explanted on (b)(6) 2023 for large lvot pseudoaneurysm and presumed culture negative endocarditis, despite extensive testing a clear etiology/mechanism was not found.The valve was replaced with an 25mm edwards aortic valved conduit.No medical records, operative notes or other information was provided to the manufacturer and the explanted valve was not returned for examination.Without this information a serial number could not be identified and thus the investigation was limited to information provided in the medwatch report.With the limited information available, the source of the endocarditis is unknown and non-bacterial thrombotic endocarditis (nbte) cannot be ruled out as the patient¿s coagulation status and history is unknown.However, because the on-x valve manufacturing process includes validated terminal sterilization prior to distribution, the valve is unlikely to be the source for an infectious endocarditis.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 0.3 %/patient-year for mechanical aortic heart valves [iso 5840-2:2021].Presumed culture negative endocarditis and the subsequent development of a pseudoaneurysm are the potential root causes for the explantation of the aortic on-x valve, in addition nbte cannot be ruled out as a potential root cause for the explantation due to the limited available information provided.Because all on-x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source for an infectious endocarditis.Root cause for the product failure mode cannot be determined; thus, severity and occurrence is not evaluated.No further action is required without additional information.The complaint has been reviewed for a capa evaluation.A definitive root cause is unknown.There is no indication that an error or deficiency occurred at artivion formerly cryolife and all risks identified have been mitigated as far as possible and residual risk is acceptable; therefore, a capa evaluation by capa department is not warranted at this time.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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 ASCENDING AORTIC 23
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX
• 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: 18518879
• MDR Text Key: 332936083
• Report Number: 1649833-2024-00003
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 00851788001525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/16/2024

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: ONXAAP-23
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening