MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	12/05/2022
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, patient in this study experienced endocarditis with infection on (b)(6) 2022.Subsequently, this on-x valve was explanted on (b)(6) 2022.
Event or Problem Description
According to the initial report received, patient in this study experienced endocarditis with infection on (b)(6) 2022.Subsequently, this on-x valve was explanted on (b)(6) 2022.
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 found to be related to the complaint.On (b)(6) 2022, the patient underwent an aortic valve replacement with an onxaap-23 sn (b)(6).The provided medical records, after translation, give a post-operative diagnosis at the time of initial discharge of ¿endocarditis aortic about bentall mechanical, complicated with abscess¿, but no microbiology results or indication of source of infection was included.Then according to the adverse event case report form they were diagnosed with endocarditis on (b)(6) 2022 (68 days post-implant), and on (b)(6) 2022 (72 days post implant) underwent an explant surgery of the onxaap device.The explanted valve was not returned for examination, and the provided medical records with limited translation were the only records available for review.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 0.3 %/patient-year for mechanical aortic heart valves [iso 5840-2:2021].Endocarditis is the root cause for the explantation of the aortic valve.Because all on-x valves undergo validated terminal sterilization prior to distribution, the valve is unlikely to be the source of the infection.Each individual hazard is mitigated and reduced as far as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu (instructions for use).No new risks were identified during the course of the review.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.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• 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: 16351226
• Report Number: 1649833-2023-00005
• Device Sequence Number: 6823991
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 851788001525
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: 08/01/2023
• Device Model Number: ONXAAP-23
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2020
• 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: 57 YR
• Patient Sex: Unknown