MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AAP UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	10/28/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report received, "subject: aap- 067 on (b)(6) 2014 1 day post implant, subject experienced atrial fib with rvr and was started on amiodarone drip iv and then was changed to amiodarone 400mg tab.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.Crfs that were provided are attached to this report.".

• Brand Name: ON-X AAP UNKNOWN CONFIGURATION
• 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: 14548128
• Report Number: 1649833-2022-00019
• Device Sequence Number: 4956554
• 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): 08/04/2022

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: 03/01/2019
• Device Model 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: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 08/04/2022
• 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; Other
• Patient Sex: Unknown