MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC ANATOMIC EXT 25; HEART-VALVE, MECHANICAL

Model Number ONXANE-25

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/05/2021

Event Type  Injury  

Event Description

According to the initial report received via email on 06-aug-2021 from the on-x life technologies product tracking associate, "aortic redo.Replaced with sn (b)(4) onxae 25 by same surgeon same hospital.".

Event Description

According to the initial report received via email on 06-aug-2021 from the on-x life technologies product tracking associate, "aortic redo.Replaced with sn (b)(6) onxae 25 by same surgeon same hospital." attempts to obtain additional information have gone unmet.

• Brand Name: ON-X AORTIC ANATOMIC EXT 25
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln. bldg. b; austin TX 78752
• MDR Report Key: 12348883
• MDR Text Key: 267495552
• Report Number: 1649833-2021-00031
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXANE-25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR