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

Model Number ONXAE-21

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/19/2023

Event Type  Injury  

Event Description

According to initial reports patient is undergoing reoperation for pvl (paravalvular leak) and hemolytic anemia.Date of implant - (b)(6)2022.Date of explant - (b)(6)2023.This investigation is relegated to onxae-21, serial number (b)(6).

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.

Manufacturer Narrative

According to initial reports, a patient undergoing reoperation for pvl (paravalvular leak) and hemolytic anemia.Date of implant - (b)(6) 2022.Date of explant - (b)(6) 2023.This investigation is relegated to onxae-21, sn (b)(6).Additional information for both implant/explant surgeries received.The device/product was returned, and an evaluation was performed.Testing and examination showed that there was no device deficiency.The cause behind the dehiscence that resulted in paravalvular leakage and reoperation is unclear.The manufacturing records for the onxae-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.A review of the available information was performed.After a careful review of the patient¿s medical records consisting of both her initial implant and re-implant and associated hospital stays the following information was collected.On (b)(6) 2023 onxae-21, sn (b)(6) was implanted with a concomitant procedure of a y-type annular enlargement with a hemashield patch.Per the tee [transthoracic echocardiogram] performed just after implant in the operating room the prosthetic avr [aortic valve replacement] functioned well and there was no evidence of pvl [ paravalvular leak].The patient was then discharged home and unknown days later she was readmitted for a re-do avr on (b)(6) 2023.A progress note written on (b)(6) 2023 reviewed a tee showing moderate to severe pvl and states that the evaluation by the hematologist concluded that there is no evidence for hemolysis, and they will plan for a re-do avr [aortic valve replacement] with repair of the pvl [paravalvular leak].During the re-do procedure the operative findings were extensive pericardial adhesions, and that the prosthetic aortic valve has partially dehisced at the non-coronary portion on the hemashield patch.Per the notes this was the region where they reconstructed the fibrous trigone.The decision was made to explant the entire valve and replace it with a smaller on-x 19mm aortic valve.The instructions for use for the on-x valve acknowledge paravalvular leak as a potential complication following prosthetic valve replacement, which may lead to reoperation as well as explantation [ifu].Historically, major paravalvular leak occurs at a rate of 0.3% per patient-year for rigid heart substitutes [iso 5840-2:2021(e)].With the available information, the cause of the pvl was identified by the surgeon, the prosthetic aortic valve had partially dehisced at the non-coronary portion on the hemashield patch.With that information we can conclude that there was no issue with the valve, and it did not contribute to the decision to explant.The patient¿s statement that she also had hemolytic anemia related to the on-x valve could not be verified, in fact, per the progress notes provided it was concluded that there was no evidence of hemolytic anemia.No further action required.A complaint and recall query was performed for onxae-21, sn (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 AORTIC STANDARD EXT 21
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson lane; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson lane; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 17136007
• MDR Text Key: 317292768
• Report Number: 1649833-2023-00015
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 851788001303
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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 Model Number: ONXAE-21
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female