MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number ONXACE-23

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

Doctor asked for 23mm aortic valve.I showed the box to him before opening it and carefully handed it to the scrub tech's sterile field.I gave scrub tech an on-x prosthetic heart valve (aortic) 23mm, expiration: 09/29/2026.I proceeded to chart the implant and fill up the inserts from the box when they asked for another valve (21mm).I showed the box to doctor before opening it and asked the tech why they needed another one.Scrub tech verbalized: "[doctor] was trying to insert/reposition the valve when it broke." then he showed me valve with the broken pieces in a bowl.Before the case ended, we suggested to do an x-ray but doctor refused.He said he got all the pieces out.Mechanical heart valve broke during surgery.This was an on-x prosthetic heart valve with conform-x sewing ring size 23mm, ref onxace-23, exp date: 2026-09-29.The valve pieces were saved, as was the original packaging.Risk was notified the day it happened.Information provided to regulatory affairs for reporting to fda.Supply chain to follow up with vendor.

• Brand Name: ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 east anderson lane; building b; austin TX 78752
• MDR Report Key: 12575969
• MDR Text Key: 274794161
• Report Number: 12575969
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2021,09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONXACE-23
• Device Catalogue Number: ONXACE-23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA