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

Model Number ONXAAP-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 10/03/2013

Event Type  Injury  

Event 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 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
• Type of Device: 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
• MDR Text Key: 293259020
• Report Number: 1649833-2022-00021
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001525
• UDI-Public: 851788001525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 33 YR
• Patient Sex: Male