MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 23; HEART-VALVE, MECHANICAL

Model Number ONXAAP-23

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

Patient Problem Atrial Fibrillation (1729)

Event Date 02/07/2022

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

Patient (b)(6) in the ascend study experienced a cardiac arrhythmia that was possibly related to the implanted on-x valve, onxaap-23, sn (b)(4).

Manufacturer Narrative

The manufacturing records for onxaap-23, 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 23 with serial number (b)(6) was implanted on (b)(6) 2022 in a 55 year old female with a past medical history of covid, strep viridans bacteremia with an aortic root abscess, chronic descending aortic dissection, severe aortic insufficiency , hypertension, type ii diabetes, immunosuppressive management status post kidney transplant, obesity, acute kidney injury and anemia.The subject was enrolled in the ascend study.On (b)(6) 2022 the patient was implanted with onxaap- 23 after a hospital admission beginning on (b)(6) 2022 for covid and strep viridans bacteremia, on (b)(6) 2022 an transesophageal echocardiogram (tee) was performed with findings of aortic root abscesses, chronic descending aortic dissection and severe aortic insufficiency.On (b)(6) 2022 (13 days post implant) the patient had one episode of paroxysmal atrial fibrillation that resolved with multiple amiodarone and magnesium boluses and she will be discharged home on an po ( by mouth) amiodarone taper regimen.According to the adverse event documentation completed by the surgeon the event lasted a total of 8 days and resolved without sequalae.The patient was discharged home (b)(6) 2022.The instructions for use [ifu] for the aap valve lists cardiac arrhythmia 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 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.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 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 23
• 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: 15962637
• MDR Text Key: 305336125
• Report Number: 1649833-2022-00067
• Device Sequence Number: 1
• Product Code: LWQ
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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 Model Number: ONXAAP-23
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Date Device Manufactured: 08/01/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female