MAUDE Adverse Event Report: ARTIVION, INC. ¿ AUSTIN ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER; HEART VALVE, MECHANICAL

Model Number ONXANE-21

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

Patient Problems Abscess (1690); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/19/2023

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 notification on 02/22/2024, "received irc with ¿implanted/explanted¿ written on card." additional information received from rep 02/28/2024: "the valve was explanted because after placement the patient had a large perivalvular leak from a root abscess.After the valve was removed, a had to do a root replacement.".

Manufacturer Narrative

According to the initial notification on 02/22/2024,"received irc with ¿implanted/explanted¿ written on card." additional information received on 02/28/2024: "the valve was explanted because after placement the patient had a large perivalvular leak from a root abscess.After the valve was removed, a had to do a root replacement.¿ additional information received 03/01/2023: would you also be able to find out: 1.What was the date the patient had the valve explanted and the date the root abscess was discovered? 2.Could you get any explant op notes for clinical? ¿everything happened on the case date.I am not able to obtain the op notes." this complaint is relegated to onxane-21, sn (b)(6).No additional information forthcoming.The manufacturing records for onxane-21, 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.Document change orders le17696 and le18072 were issued for leaflet tuning as a part of the standard manufacturing process.The available information was reviewed.On 21feb2024 an artivion employee in device tracking was notified on an implant/explant of an aortic mechanical valve by the notation of ¿implant/explant¿ handwritten onto the returned implant registration card [irc] and an investigation was started.This complaint is regarding onxane ¿ 21 sn (b)(6) implanted and explanted on (b)(6) 2023 in a 52-year-old male.On (b)(6) 2023 onxane ¿ 21 sn (b)(6) was implanted and explanted the same day.According to information provided by the surgeon ¿the valve was explanted because after placement the patient has a large perivalvular leak from a root abscess.After the valve was removed, had to do a root replacement¿.The valve was not returned for inspection and no medical records were provided.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 information that the pvl [paravalvular leak] was identified by the surgeon as being caused by a root abscess at the time of implant/explant we can conclude that there was no issue with the valve, and it did not contribute to the decision to explant.No further action necessary.The information was reviewed to compile a risk report.The review of the dhr was acceptable with the final product meeting all specifications.The valve was not returned for inspection and no medical records were provided.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 information that the pvl [paravalvular leak] was identified by the surgeon as being caused by a root abscess at the time of implant/explant we can conclude that there was no issue with the valve, and it did not contribute to the decision to explant.A product failure mode cannot be identified; thus, severity and occurrence is not evaluated.No further action necessary.Based on the available information, a root cause for this event cannot be determined.The product was not returned so no direct observation could be made.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.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 PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC. ¿ AUSTIN; 1300 east anderson lane; building b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; austin TX 72379
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18831385
• MDR Text Key: 336862116
• Report Number: 1649833-2024-00022
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001655
• UDI-Public: 00851788001655
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXANE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2022
• 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; Required Intervention; Other