MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL

Model Number ONXACE-21

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/11/2023

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 this is subject 331 from the on-x aortic post-approval study.The subject was hospitalized due to valve thrombosis.The medical record received relayed that a transthoracic echocardiogram was performed.The report stated "mechanical avr in situ appears well-seated, no obvious signs of dehiscence.No obvious mobile structures see attached to the prosthetic valve." no additional information forthcoming.This investigation is relegated to onxace-21 serial number: (b)(6).

Manufacturer Narrative

The manufacturing records for onxace-21 sn (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 found.Document change orders (b)(6) were issued for leaflet tuning as a part of the standard manufacturing process.Per the provided medical records the following sequence of events occurred: the subject was seen in the clinic on (b)(6) 2023 for complaints of soboe [shortness of breath on exertion] and dysphagia, a bedside echocardiogram was performed in office showing high gradients and possible valve dysfunction.Due to the results of this echocardiogram the subject was admitted to the hospital for further testing to include a toe [transesophageal echocardiogram] and ekg.Inr at the time of admission was 1.1 and the subject was started on cleaxne [a low molecular weight heparin] 132mg daily and resumed their home dose of coumadin [9mg daily].The tee performed on (b)(6) 2023 showed an aortic valve thrombus.Subsequent tests are as follows: tee [transthoracic echocardiogram] performed on (b)(6) 2023 with the following findings ¿mechanical aortic valve replacement (23mm on- x) appears well-seated.No obvious mobile structures seen attached to the prosthetic valve.Severely increased transvalvular velocities.Peak velocity of 4.4 m/s and a mean pressure gradient of 48.82 mmhg.There are two paravalvular leaks - one arising from 9 - 11 o ' c lock and one from 1 ¿ 4 o'clock from the psax view - overall mild to moderate/moderate at most aortic regurgitation.¿ a repeat tte on (b)(6) 2023 showed improved peak velocity.A ctca [cardiac angiogram ct] performed on (b)(6) 2023 with the following findings ¿ well seated mechanical bi-leaflet av prosthesis.Likely restricted motion of the anterior leaflets with focal 9mm thrombus in situ.Minimal low-density change, likely connected to the thrombus, also noted above valve rim to the left.No left atrial appendage thrombus.Intact inter-atrial septum.Bi-atrial dilatation.Unchanged mild dilatation of the ascending aorta (41 x 38mm), given background bicuspid aortic valve pre -operatively.¿ subject was discharged for outpatient follow up with the recommended inr range of 3-4.Thrombosis is a rare, but a known potential complication of prosthetic valve replacement occurring at a historical rate of 0.1% per patient-year for mechanical aortic 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].It is suspected that the root cause of the thromboembolism is a subtherapeutic inr of 1.1, as in many such cases the subtherapeutic inr is the cause of the formation of thromboembolism.The patient was enrolled in the on-x aortic post approval study; thus, severity and occurrence is not evaluated.The suspected cause of the described event is subtherapeutic inr.Thrombosis is a rare, but a known potential complication of prosthetic valve replacement occurring at a historical rate of 0.1% per patient-year for mechanical aortic 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].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.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.

Event Description

According to the initial report received via email on 02oct2023, "this is subject 331 from the on-x aortic post-approval study.The subject was hospitalized due to valve thrombosis." the medical record received relayed that a transthoracic echocardiogram was performed.The report stated "mechanical avr in situ appears well-seated, no obvious signs of dehiscence.No obvious mobile structures see attached to the prosthetic valve." based on the adjudication form completed this event is unrelated to the valve.Additional information received from artivion clinical trial manager, "this event for 331 was looked into further and was reclassified as valve thrombosis." no additional information forthcoming.This investigation is relegated to onxace-21, serial number: (b)(6).

• Brand Name: ON-X AORTIC CONFORM EXT 21
• 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: 18256038
• MDR Text Key: 329600669
• Report Number: 1649833-2023-00043
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2018
• 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
• Treatment: ANTICOAGULANT THERAPY: WARFARIN, CLEAXNE; ANTICOAGULANT THERAPY: WARFARIN, CLEAXNE
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 39 YR
• Patient Sex: Female