MAUDE Adverse Event Report: CRYOLIFE, INC. ON-X PROSTHETIC AORTIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 23 MM 98326

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem Death (1802)

Event Date 01/09/2020

Event Type  Death  

Event Description

Pt undergoing mitral valve transplant due to chronic diastolic congestive heart failure class 3.Surgeon requested 23 mm on-x mechanical mitral valve.Circulating nurse mistakenly selected 23 mm on-x-aortic valve.During verification, circulating nurse and tech followed the mfr's ifu to check the expiration date and serial number against the mfr implant form.The aortic and mitral valves are packaged with an attached holder to prevent manual manipulation and damage to the valve.There is very little visual difference between the aortic valve and holder compared to the mitral valve and holder.Not recognizing he had been given an aortic valve, the surgeon unknowingly implanted an aortic valve instead of the planned mitral valve.Attempts to wean the pt off bypass were unsuccessful and the pt expired in surgery.The implant error was not discovered until the following day.Fda safety report id# (b)(4).

• Brand Name: ON-X PROSTHETIC AORTIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC.
• MDR Report Key: 9621517
• MDR Text Key: 176229258
• Report Number: MW5092388
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23 MM 98326
• Device Catalogue Number: ONXACE-23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 107