MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 23; HEART-VALVE, MECHANICAL

Model Number	ONXAAP-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	10/03/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, subject in the on-x ascending aortic prosthesis (aap)- single site retrospective study experienced the following event: on (b)(6) 2013 99 days post implant, subject experienced a 10 day hospitalization for a non-st-elevation myocardial infarction.At the time of the hospitalization the subjects international normalized ratio (inr) was 3.5.Subject received a heart cath (catheterization) and was discharged on (b)(6) 2013.On (b)(6) 2013, the subject had reoperation; coronary artery bypass graft surgery.No further details of the event were provided.
Event or Problem Description
According to the initial report, subject in the on-x ascending aortic prosthesis (aap)- single site retrospective study experienced the following event: on (b)(6) 2013 99 days post implant, subject experienced a 10 day hospitalization for a non-st-elevation myocardial infarction.At the time of the hospitalization the subjects international normalized ratio (inr) was 3.5.Subject received a heart cath (catheterization) and was discharged on (b)(6) 2013.On (b)(6) 2013, the subject had reoperation; coronary artery bypass graft surgery.No further details of the event were provided.

• Brand Name: ONX ASCENDING AORTIC 23
• 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: 14591655
• Report Number: 1649833-2022-00021
• Device Sequence Number: 20286346
• 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
• 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
• Device Expiration Date: 09/01/2017
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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: Hospitalization; Life Threatening
• Patient Age: 33 YR
• Patient Sex: Male