MAUDE Adverse Event Report: SORIN GROUP/MICROPORT MITROFLOW AORTIC PERICARDIAL HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MITROFLOW LXA21

Patient Problems Chest Pain (1776); Dyspnea (1816); Valvular Stenosis (2697)

Event Type  Injury  

Event Description

Medtronic received information that approximately seven years following the implant of this sorin valve, the patient presented with dyspnea with mild exertion and occasional exertional chest pain.Echocardiogram shows av thickening with decreased mobility, mean gradient of 28 mmhg, ava of 1.0 cm squared with index of 0.46 cm squared consistent with a new stenosis and severe patient prosthetic mismatch.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN GROUP/MICROPORT; 5677 airline road; arlington TN 38002
• MDR Report Key: 18874301
• MDR Text Key: 337462836
• Report Number: MW5152530
• Device Sequence Number: 1
• Product Code: LWR
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MITROFLOW LXA21
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1