MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
According to the initial report received, study patient experienced cardiac arrhythmia on (b)(6) 2021, 1-day following implant with the device (implanted on (b)(6) 2021).
Additional Manufacturer Narrative
The manufacturing records for onxaap-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.An onxaap 25 with serial number (b)(6) was implanted on (b)(6) 2021 in a 52-year-old male with a past medical history of aortic stenosis, thoracic aortic aneurysm without rupture, hypertension, obesity, and obstructive sleep apnea.The subject was enrolled in the study and this event refers to study patient.On (b)(6) 2021 the patient was seen by his doctor for his obstructive sleep apnea and in the medical notes it states a history of ¿paroxysmal atrial fibrillation post operation¿one episode of irregularity, remains on bb (beta blockers).¿ the adverse event documentation completed by the surgeon lists (b)(6) 2021 as the start date as the event is described as ¿post operation¿ and no specific start date is given.The risk management and usability engineering file for the on-x ascending aortic prosthesis was reviewed.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.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible and residual risk is acceptable.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.References: on-x® ascending aortic prosthesis with the vascutek gelweave valsalvatm graft, instructions for use.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT
• Common Device Name: 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: 15933930
• Report Number: 1649833-2022-00063
• Device Sequence Number: 19948152
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 851788001532
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: ONXAAP-25
• Device Catalogue Number: ONXAAP-25
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022; 11/17/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/16/2023; 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 168 KG