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

Model Number MITROFLOW 23 MM

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2018

Event Type  malfunction  

Event Description

Medtronic received information that five years and eight months post implant of this bioprosthetic valve implanted in the pulmonary position of a pediatric patient, a transcatheter pulmonary valve (tpv) was implanted valve-in-valve.The reason for the intervention is unknown.No additional 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: 17529823
• MDR Text Key: 321134769
• Report Number: MW5136746
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MITROFLOW 23 MM
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1