MAUDE Adverse Event Report: SORIN MITROFLOW; SIZER, HEART-VALVE, PROSTHESIS

Model Number 19MM MITROFLOW

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Medtronic received information that a transcatheter bioprosthetic valve was implanted into a degenerated sorin 19mm mitroflow aortic bioprosthesis resulting in a valve gradient of 53mmhg.No other adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MITROFLOW
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN
• MDR Report Key: 17532047
• MDR Text Key: 321519596
• Report Number: MW5138957
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 19MM MITROFLOW
• Patient Sequence Number: 1