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

Model Number	ONXAAP-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, "subject: (b)(6) on (b)(6) 2016 124 days post implant, subject experienced thrombosis which required a coronary angiography ((b)(6) 2016), redo sternotomy ((b)(6) 2016) and ascending aortic arch replacement ((b)(6) 2016).The implant was also removed on (b)(6) 2016.At time of hospitalization the subjects inr was 2.6.They were discharged on (b)(6) 2016.Subject in the post market study: (b)(6)- post market clinical follow up study protocol of the on-x ascending aortic prosthesis (aap)- single site retrospective study.Pi: [surgeon].While artivion representative was performing paper crf review, adverse events were discovered as they were documented in crf submitted for study.Medical records/source documentation has not been provided for review and will not likely be obtained.Given the retrospective nature, these events are not current.(study timeline is 2008-2018) identified events were reported to field assurance in a per subject report.".

• Brand Name: ONX ASCENDING AORTIC 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: 14744808
• Report Number: 1649833-2022-00031
• Device Sequence Number: 17464962
• Product Code: LWQ
• UDI-Device Identifier: 00851788001532
• UDI-Public: 851788001532
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2020
• Device Model Number: ONXAAP-25
• Device Catalogue Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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 Sex: Unknown