MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING AND EXTENDED HOLDER; HEART VALVE, MECHANICAL

Model Number ONXAE-19

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

Patient Problem Unspecified Heart Problem (4454)

Event Date 02/13/2024

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 via email on 04/04/2024 , ¿received implant registration card for patient with existing aortic implant.Please confirm that this is an explant.¿ additional information received 04/10/2024- ¿there was no alleged valve deficiency per se; doctor did find sub annular pannus formation about 1mm in length.Patient pannus surgeon thought due to extensive root enlargement needed to do even the first onx 19mm replacement.Patient is doing very well now & surgeon nor hospital open to sending in op notes.No, valve was not kept.".

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING AND EXTENDED HOLDER
• Type of Device: HEART VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE 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 boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 19105299
• MDR Text Key: 340164880
• Report Number: 1649833-2024-00025
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001389
• UDI-Public: 00851788001389
• 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
• Report Date: 04/15/2024

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 Expiration Date: 02/01/2012
• Device Model Number: ONXAE-19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2007
• 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