MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number	ONXMC-25/33
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2025
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 ¿ formerly cryolife/jotec.
Event or Problem Description
An irc (implant registration card) for onxm-27/29 a0389008, implant date - (b)(6) 2025 was received from the user facility for a patient with a previous on-x mitral implant, onxmc-25/33 (b)(6), implant date (b)(6) 2023.This event is relegated to onxmc-25/33 (b)(6) for explant.
Additional Manufacturer Narrative
An implant registration card for onxm-27/29 a0389008, implant date (b)(6) 2025 was received from the user facility for a patient with a previous on-x mitral implant, onxmc-25/33 (b)(6), implant date (b)(6) 2023.This event is relegated to onxmc-25/33 (b)(6) for explant.Additional information received.According to the surgeon, explant was due to "medication non-adherence." the manufacturing records for the onxmc-25/33 (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.A review of the available information was performed.On (b)(6) 2023 an onxmc 25/33 sn (b)(6) was used in a case for a 51-year-old female in the mitral position.A second aortic on-x was reported to device tracking as implanted in the same position, same patient: (b)(6) 2025 onxm 27/29 sn (b)(6) (788 days or just over 2 years post-implant).This event is associated with onxmc-25/33 sn (b)(6).Review of manufacturing records show no processing issues.The valve was not returned to the manufacturer for examination.A response received from the implanting surgeon did not specify that a thrombosis necessitated the explant, however as they cited patient nonadherence to coumadin therapy as the reason for explant a thrombosis on the valve is a plausible explanation.A note from the artivion representative corroborated this, stating: ¿communicated w/ [surgeon] over the weekend; mitral re-do was due to patient non-compliance to taking coumadin.Patient got another on-x as she promised to take her medication properly this time around.No deleterious effects on patients; caught in time.No product deficiencies¿.Thrombosis is a rare, but a known potential complication of prosthetic valve replacement occurring at a historical rate of 0.2% per patient-year for mechanical mitral heart valves [iso 5840-2:2021 (e)].It is recognized as a potential adverse event for the on-x valve along with the potential for reoperation and explantation [ifu].The cause of the explantation was patient nonadherence to anticoagulation therapy (coumadin), that possibly caused a thrombosis to form on the valve.However, due to the lack of medical records or supporting lab data, this cannot be independently confirmed.As such, we are unable to determine whether the device itself contributed to the clinical outcome or the decision to explant.No further action is required without further information.A complaint and recall query was performed for onxmc-25/33 (b)(6) to identify previously reported complaints or recalls associated with this serial number.No complaints or recalls were identified for this serial number.Based on the available information, a definitive root cause for this event cannot be determined.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.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion, formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Artivion 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, formerly cryolife/jotec is accurate or has been confirmed by artivion, formerly cryolife/jotec.

• Brand Name: ONX MITRAL CONFORM 25/33
• 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: 22385967
• Report Number: 1649833-2025-00022
• Device Sequence Number: 17917413
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 00851788001303
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: ONXMC-25/33
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female