MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 19; HEART-VALVE, MECHANICAL

Model Number ONXACE-19

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

Patient Problems Death (1802); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2020

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the implant summary cards received, "2 ircs received for same patient, same surgery onxace and onxmc both ircs indicate implanted and removed." this investigation will be relegated to onxace-19, sn (b)(4).Received notification the patient expired on (b)(6) 2021.

Event Description

Received additional information per operative notes that there was no deficiency with the valve and it functioned as intended.

• Brand Name: ONX AORTIC CONFORM EXT 19
• 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: 11236029
• MDR Text Key: 228855415
• Report Number: 1649833-2021-00004
• 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: 03/11/2021

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 Operator: No Information
• Device Model Number: ONXACE-19
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 03/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other