MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 27/29; HEART-VALVE, MECHANICAL

Model Number ONXAAP-27/29

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

Patient Problem Arrhythmia (1721)

Event Date 04/11/2022

Event Type  Injury  

Event Description

Patient: (b)(6) in the ascend study experienced three (3) adverse events that were possibly related to the implanted on-x valve [onxaap-27/27 sn: (b)(4)]: on (b)(6) 2022: seizure.On (b)(6) 2022: cardiac arrhythmia.On (b)(6) 2022: mediastinal hematoma overlying the right ventricle with compression.This investigation will be relegated to the on (b)(6) 2022 event.

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.

Manufacturer Narrative

The manufacturing records for onxaap-27/29, serial number (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.An onxaap 27/29 with serial number (b)(6) was implanted on (b)(6) 2022 in a 32 year old male with a past medical history of an prior mechanical valve repair in 2009, end stage renal disease [esrd] status post bilateral nephrectomy due to congenital polycystic kidney disease, hypertension, severe obesity, and a thoracic aortic aneurysm with an aortic root of 5.4cm severe, aortic insufficiency with an ejection fraction of 30% and mild mitral regurgitation.The subject was enrolled in the ascend study.On (b)(6) 2022 (6 days post implant) the patient experienced an episode of bradycardia during hemodialysis [hd], according to the adverse event report the event lasted one day and resolved without sequelae.The medical note states the following: the patient became bradycardic during hd, was asymptomatic with stable vital signs.He was sleeping and the tele alarmed hr 30¿s-40¿s and once he was awoken by the nurse his heart rate returned to the 70¿s.Upon review of the cardiac monitor history additional episodes were discovered at 4am the previous night and 2 days ago.The patient was treated by holding his coreg and changing his amiodarone dose to 200mg daily.No further notes or information was provided regarding this event.The instructions for use [ifu] for the aap valve lists cardiac arrhythmia (bradycardia) as a potential adverse event for mechanical prosthetic valve recipients.There is no indication that the on-x valve contributed in any way to the reported episode and it is more likely a complication related to the surgical procedure itself rather than the valve.The event of cardiac arrhythmia is a known potential complication, however, there is no indication that the on-x valve contributed in any way to the reported episode and it is more likely a complication related to the surgical procedure itself rather than the valve.The on-x heart valve risk management file thoroughly identifies the process and product hazards for indication.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.Based on the available information, the root cause is unknown.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 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: ONX ASCENDING AORTIC 27/29
• 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: 15960683
• MDR Text Key: 305280369
• Report Number: 1649833-2022-00065
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001549
• UDI-Public: 851788001549
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• 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-27/29
• Device Catalogue Number: ONXAAP-27/29
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• 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): Other
• Patient Age: 32 YR
• Patient Sex: Male