MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 25; HEART-VALVE, MECHANICAL

Model Number	ONXACE-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Thromboembolism (2654)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, "patient is in the (b)(6) study.He attended the hospital (emergency department likely) with headaches, diagnosed with transient ischaemic attack / mature lacunar infarcts r caudate.No additional information is currently available; neurology record requested from the site.".

• Brand Name: ONX AORTIC CONFORM EXT 25
• 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: 12917285
• Report Number: 1649833-2021-00043
• Device Sequence Number: 20263561
• Product Code: LWQ
• UDI-Device Identifier: 00851788001471
• UDI-Public: 851788001471
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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
• Device Expiration Date: 05/21/2021
• Device Model Number: ONXACE-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male