MAUDE Adverse Event Report: SORIN GROUP / CORCYM CANADA CORP. MITROFLOW PERICARDIAL HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Patient Problem Failure of Implant (1924)

Event Date 07/18/2023

Event Type  malfunction  

Event Description

It was learned that a 27mm sorin mitroflow valve underwent a valvein- valve on (b)(6) 2023.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MITROFLOW PERICARDIAL HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN GROUP / CORCYM CANADA CORP.
• MDR Report Key: 18291501
• MDR Text Key: 330157588
• Report Number: MW5149032
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1