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

Model Number	ONXAE-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received, an on-x valve implanted in 2017 was explanted and replaced due to pannus growth.
Additional Manufacturer Narrative
The manufacturing records for onxae-19, serial number (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.During the investigation no non-conformances or deviations were noted.On (b)(6) 2017 an onxae-19 sn (b)(6) was used in a case for an unidentified patient in the mitral position.This valve was explanted and replaced on (b)(6) 2022 (1,178 days post implant) by an unknown valve type and size.As per the surgeon, the subject ¿had a 19 onyx mitral valve in 2017, back in surgery today, found pannus formation.¿ one photograph was provided and reviewed, but no other records or information were made available.Multiple attempts were made to contact the surgeon for further information, and we were not able to obtain anything further.The valve was not returned to the manufacturer for evaluation; however, manufacturing records for this valve show a product meeting all requirements and acceptable for distribution.Pannus formation resulted in explant 4 years and 10 months postop.The instructions for use (ifu) identify explantation as a risk factor due to adverse events including pannus [instructions for use].The frequency of occurrence for pannus is not established and has been reported for the on-x valve only anecdotally (see, for example, han 2015 for an aortic case and abad 2016 for a tricuspid case).However, bonnichsen et al.Reiterate the claim by vitale et al.That thrombosis and pannus are both present in as many as 45% of cases of obstructed mechanical valves (on-x was not evaluated in this particular study) [bonnichsen 2015, vitale 1997].Pannus formation is a known risk factor for foreign body implants such as on-x valves per our instructions for use [ifu].The on-x heart valve risk management file was reviewed and found to thoroughly identify the process and product hazards for indications.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.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.References: abad c, et al.Dysfunction of an on-x heart valve by pannus, j heart valve dis 2016 sep;25(5):634-637.Bonnichsen cr & pellikka pa, prosthetic valve thrombus versus pannus ¿ progress with imaging, circ cardiovasc imaging 2015;8: doi: 10.1161/circimaging.115.004283.Han k, et al.Subprosthetic pannus after aortic valve replacement surgery: cardiac ct findings and clinical features, radiology 2015;v276n3:724-731.On-x instructions for use including aortic valve inr 1.5-2.0 update.Http://www.Onxlti.Com/ifu.Vitale n, et al.Obstruction of mechanical mitral prostheses: analysis of pathologic findings, ann thorac surg 1997;63:1101-1106.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH STANDARD 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: 15066693
• Report Number: 1649833-2022-00041
• Device Sequence Number: 20197546
• Product Code: LWQ
• UDI-Device Identifier: 00851788001389
• UDI-Public: 851788001389
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: ONXAE-19
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown