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-25

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

Patient Problems Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 09/22/2023

Event Type  Injury  

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 Description

According to the initial report received via email on 26sept2023, "aap irc received for patient with an existing aap valve." additional information received: patient had endocarditis (b)(6) 2022, he also had a bicuspid valve.Therefore avr/asc.Completed iv abx.(b)(6) 2022 switched from warfarin to eliquis.(b)(6) 2023 pt presented with ischemic cva., echo noted thrombus v endocarditis.Pt transferred to (b)(6).Intra-op danter described thrombus on valve.Culture: negative for organisms.Fibrous tissue with adherent fibrin - chronic and acute inflammation.Id following off abx- all cultures negative to date.Patient still in post op ¿ not yet released as of today,(b)(6) 2023.".

Manufacturer Narrative

A sample evaluation could not be performed as the device was not returned.The manufacturing records for onxm-25 sn (b)(6) were reviewed.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.The available information was reviewed.An onxaap ¿ 25 sn (b)(6) was implanted on (b)(6) 2022 in a 29-year-old male patient with a documented medical history of bicuspid aortic valve and endocarditis.On (b)(6) 2023 an eirc was received for this patient for another onxaap implant: onxaap ¿ 27/29 sn (b)(6) implanted on (b)(6) 2023 and an investigation was opened.In (b)(6) 2023 (approximately 578 days post implant) the patient presented and was diagnosed with ischemic cva and underwent an explant/implant on (b)(6) 2023 with a new onxaap 27/29 sn (b)(6) implanted.The patient presented in (b)(6) 2022 with endocarditis and received an onxaap implant and completed antibiotics.In (b)(6) 2022 the patient was had an anticoagulation change and then in (b)(6) 2023 they presented and were diagnosed with ischemic cerebral vascular accident (cva).An echocardiogram was completed showing thrombus vs.Endocarditis and a reoperation was planned.During the reoperation the thrombus was described as fibrous tissue with adherent fibrin, chronic on acute inflammation.Cultures were taken and were negative, infectious disease is following the patient and they are off antibiotics, all cultures negative to date ((b)(6) 2023).With the provided information we are unable to conclusively determine if the onxaap is the sole cause of the valve thrombus or if the change to the patient¿s anticoagulation regimen in (b)(6) 2022 or history of endocarditis contributed to the event.There are no records available (e.G., coagulation/inr status and pharmaceutical treatment or compliance) to determine the cause of the thrombosis and the aap device was not returned to the manufacturer for evaluation.The device history record concluded that the aap device passed on-x acceptance criteria prior to initial release.The instructions for use [ifu] for the on-x ascending aortic prosthesis lists thrombosis as a potential adverse event for aortic valve graft recipients with the potential for reoperation and explantation.Though rare, it occurs at a historical rate of (b)(4) per patient-year for aortic mechanical valves in general [iso 5840-2:2021(e)].With the provided information we are unable to conclusively determine if the onxaap is the sole cause of the valve thrombus or if the change to the patient¿s anticoagulation regimen in (b)(6) 2022 or history of endocarditis contributed to the event.We do not have available published data to support the safety and efficacy of using factor xa inhibitors in place of the current standard of care [vka ¿ vitamin k antagonists] for aortic and mitral mechanical valves.No further action is required without further information.A review of the information was performed to compile a risk analysis.With the provided information we are unable to conclusively determine if the onxaap is the sole cause of the valve thrombus or if the change to the patient¿s anticoagulation regimen in (b)(6) 2022 or history of endocarditis contributed to the event.We do not have available published data to support the safety and efficacy of using factor xa inhibitors in place of the current standard of care [vka ¿ vitamin k antagonists] for aortic and mitral mechanical valves.A product failure mode cannot be identified; thus, severity and occurrence is not evaluated.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; 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: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• Type of Device: 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: 17834152
• MDR Text Key: 324477420
• Report Number: 1649833-2023-00034
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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 Operator: Lay User/Patient
• Device Expiration Date: 01/01/2024
• Device Model Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2021
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male