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

Device Problem Insufficient Information (3190)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Event Description

Medtronic received information that five years and three months following the implant of a sorin mitroflow surgical aortic valve, regurgitation developed.A transcatheter bioprosthetic valve was implanted valve in valve.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: MICROFLOW
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): SORIN
• MDR Report Key: 17523520
• MDR Text Key: 321136233
• Report Number: MW5130468
• 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: 03/27/2017

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
• Patient Sequence Number: 1