MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL

Model Number	ONXACE-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, "patient is subject (b)(6) in the (b)(6) post approval study.Neurologic thromboembolism, subacute infarction was reported to have lasted 3 days and fully resolved with no treatment." adjudication determined this event to be valve-related.This investigation will be relegated to onxace-21, sn (b)(4).

• Brand Name: ONX AORTIC CONFORM EXT 21
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 12746829
• Report Number: 1649833-2021-00041
• Device Sequence Number: 4126475
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 851788001457
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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 Expiration Date: 06/27/2023
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other