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

Model Number	ONXAAP-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, subject: (b)(6) in the aortic prosthesis (aap)- single site retrospective study, experienced the following event: on (b)(6) 2017, 9 days post implant, subject experienced a heart block which resulted in a pacemaker being implanted.At time of hospitalization the subjects inr was 3.2.
Additional Manufacturer Narrative
The manufacturing records for sn (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.An on-x valve with serial number (b)(6) with a prefabricated ascending aortic graft of size 23 was implanted with an concomitant ascending aortic root repair on (b)(6) 2017 in a 53 year old male with a medical history of alcohol use, hypertension, hyperlipidemia, bladder cancer, bicuspid valve disease, and aortic aneurysm of the aortic root ,the ascending aorta and the hemiarch whose records were retrospectively acquired for a post-market study: ox1901.000-m (11/20)- post market clinical follow up study protocol of the on-x ascending aortic prosthesis (aap)- single site retrospective study.This event refers to study patient number (b)(6).On (b)(6) 2017 (4 days post implant) the patient developed post- op heart block and a temporary pacemaker was used, then on (b)(6) 2017 (9 days post implant) a permanent pacemaker was implanted.As the permanent pacemaker was implanted within 14 days of aortic valve replacement, the pacemaker implant is considered a valve related event per the atkins (2008) guidelines.The instructions for use [ifu] for the aap valve list cardiac arrhythmia as a potential adverse event for mechanical prosthetic valve recipients.This event is reported here only for the purpose of consistency in documenting potential adverse events made known to the manufacturer and does not qualify for comparison to the historical record of valve performance.The arrhythmia event is a probable consequence of the aortic valve replacement surgical procedure.The arrhythmia/pacemaker implantation is considered valve related as it occurred less than 14 days post aortic valve replacement.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.
Event or Problem Description
According to the initial report, subject: aap- 093 in the aortic prosthesis (aap)- single site retrospective study, experienced the following event: (b)(6) 2017 9 days post implant, subject experienced a heart block which resulted in a pacemaker being implanted.At time of hospitalization the subjects inr was 3.2.

• 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: 14822936
• Report Number: 1649833-2022-00039
• Device Sequence Number: 4813752
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 851788001525
• 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
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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: 05/01/2021
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/27/2022
• 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: 06/26/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 79 KG