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

Model Number	ONXMC-25/33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Shock (2072); Thrombosis/Thrombus (4440)
Type of Reportable Event	Death
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
During the oct 2025 annual literature search for on-x heart valves (aortic and mitral) for sustaining mdr reporting we discovered the following publication by honganur et al ¿shock after redo surgery for mechanical mitral valve thrombosis¿.This is a case report of an: 74-year-old female with history of on-x #25/33 mm mechanical mitral valve replacement (mvr) secondary to rheumatic heart disease presented with 2 day history of worsening dyspnea and hemoptysis.Inr was 2.2.Tee: restricted motion of medial prosthetic disk due to large thrombus & free motion of lateral disk.Color doppler: mild mr.Following 2 weeks of anticoagulation with heparin and warfarin her symptoms persisted and lhc revealed ongoing obstruction of medial disk and moderate lad and diagonal disease.Heart team recommended against thrombolysis or catheter-based therapies due to large thrombus burden.She was deemed high, not prohibitive, risk for redo mvr; she was agreeable.She underwent two vessel bypass surgery and mvr with a bioprosthesis.Surgery was complicated by shock and incessant ventricular arrhythmia.Post-surgery, shock worsened and she was transitioned to comfort care.This investigation is relegated to onxmc-25/33 serial number: unknown with allegation of thrombosis and death.
Additional Manufacturer Narrative
Attempts to obtain additional information have gone unmet.No additional information forthcoming.This investigation is relegated to onxmc-25/33 serial number: unknown with allegation of thrombosis and death.The publication "shock after redo surgery for mechanical mitral valve thrombosis" by honganur et al., presented in jacc (supplement a) on (b)(6) 2025, is reviewed here.This case involves a 74-year-old female with an on-x #25/33 mm mechanical mitral valve who presented with worsening dyspnea and hemoptysis.The inr was 2.2.Transesophageal echocardiography (tee) demonstrated restricted motion of the medial prosthetic disk due to a large thrombus with free motion of the lateral disk, and color doppler showed mild mitral regurgitation.After two weeks of anticoagulation with heparin and warfarin, symptoms persisted; angiography revealed ongoing obstruction of the medial disk and moderate lad and diagonal disease.The heart team recommended against thrombolysis or catheter-based therapies due to large thrombus burden.The patient underwent two-vessel coronary artery bypass surgery and redo mitral valve replacement with a bioprosthetic valve.Surgery was complicated by shock and incessant ventricular arrhythmia, and the patient was transitioned to comfort care.The authors conclude that expedited evaluation is crucial in the management of suspected mechanical valve thrombus; while thrombolytics or interventional techniques may be options for small thrombus, redo surgery may be required for heavy thrombus burden to mitigate stroke risk despite elevated operative risk.Although there is no evidence of valve involvement, the instructions for use for the on-x valve lists death as a possible complication of mechanical heart valve replacement [ifu].Published data estimate an operative mortality rate of (b)(4) following mitral valve replacement surgery (bowdish et al.).Thrombosis, thromboembolism, explant and death are recognized adverse events associated with mechanical heart valves and are listed in the device's instructions for use (ifu).The investigation is limited by the lack of medical records and supporting clinical data.While thrombosis/thromboembolism are recognized risks, we are unable to determine whether the device, patient condition, anticoagulation management, or a combination of these factors contributed to the event.Although there is no evidence of valve involvement, death is listed as a possible complication in the device ifu, and published data estimate an operative mortality rate of (b)(4) following mitral valve replacement surgery (bowdish et al.).The investigation is limited by the lack of medical records and supporting clinical data.While thrombosis/thromboembolism are recognized risks, we are unable to determine whether the device, patient condition, anticoagulation management, or a combination of these factors contributed to the event.Thus, severity and occurrence are not evaluated.A root cause is unknown.The investigation is limited by the lack of medical records and supporting clinical data.While thrombosis/thromboembolism are recognized risks, we are unable to determine whether the device, patient condition, anticoagulation management, or a combination of these factors contributed to the event.Although there is no evidence of valve involvement, death is listed as a possible complication in the device ifu, and published data estimate an operative mortality rate of (b)(4) following mitral valve replacement surgery (bowdish et al.).There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.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 MITRAL CONFORM 25/33
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFEW 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 blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 23522888
• Report Number: 1649833-2025-00041
• Device Sequence Number: 21265651
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 00851788001303
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Sex: Female