MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW LXA; TISSUE HEART VALVE

Model Number LXA23

Device Problem Gradient Increase (1270)

Patient Problems Pulmonary Insufficiency (2022); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 11/07/2016

Event Type  Injury  

Event Description

A patient was implanted with a mitroflow lxa size 23 (sn (b)(4)) on (b)(6) 2013.At the time of implant the patient was (b)(6) years old.On (b)(6) 2016 the patient underwent to a re-operation for the replacement of the bioprosthesis due to degradation at the (b)(6) hospital.Based on the information available, the patient had pulmonary stenosis in the mitroflow valve (45-50 mmhg) with pulmonary regurgitation, right chamber enlargement and decreased right ventricle mobility.

• Brand Name: MITROFLOW LXA
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 8834805
• MDR Text Key: 152499795
• Report Number: 1718850-2019-01044
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000115
• UDI-Public: (01)00896208000115(240)LXA23(17)160430
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: LXA23
• Device Catalogue Number: LXA23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/03/2019
• Device Age: 67 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR