MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESISWITH THE VASCUTEK GELWEAVEVALSALVA GRAFT; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/09/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
In performing a paper case report form (crf) review of the aortic prosthesis (aap)- single site retrospective study, the following adverse event was discovered for subject (b)(6): on 09jun2015 6 days post implant, subject experienced complete heart block and had a permanent pacemaker implanted.The subject was discharged the following day.
Event or Problem Description
In performing a paper case report form (crf) review of the aortic prosthesis (aap)- single site retrospective study, the following adverse event was discovered for subject (b)(6): on 09jun2015 6 days post implant, subject experienced complete heart block and had a permanent pacemaker implanted.The subject was discharged the following day.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESISWITH THE VASCUTEK GELWEAVEVALSALVA GRAFT
• 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: 14708306
• Report Number: 1649833-2022-00025
• Device Sequence Number: 20102530
• Product Code: LWQ
• UDI-Device Identifier: 00851788001518
• UDI-Public: 851788001518
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 09/01/2017
• Device Model Number: ONXAAP-21
• Device Catalogue Number: ONXAAP-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/16/2022
• 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: 06/15/2022
• Supplement Report FDA Received Date: 08/10/2022
• 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; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Male