MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHNAICAL

Model Number	ONXACE-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received via a phone conversation on (b)(6) 2022 with cryolife sales representative (csr), one of my surgeons just called to report that a patient of his has been admitted today [(b)(6) 2022] for a stroke.The patient had an onx aortic valve implanted possibly in (b)(6) 2021.Per the surgeon the "patient is doing ok.".
Event or Problem Description
According to the initial report received via a phone conversation on (b)(6) 2022 with cryolife sales representative (csr), one of my surgeons just called to report that a patient of his has been admitted today [(b)(6) 2022] for a stroke.The patient had an onx aortic valve implanted possibly in (b)(6) 2021.Per the surgeon the "patient is doing ok.".

• Brand Name: ONX AORTIC CONFORM EXT 23
• Common Device Name: HEART-VALVE, MECHNAICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson ln.; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson ln.; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 13235449
• Report Number: 1649833-2022-00002
• Device Sequence Number: 19934721
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 851788001464
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2022

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: 09/24/2026
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Sex: Female