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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW LXA; TISSUE HEART VALVE
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LIVANOVA CANADA CORP. MITROFLOW LXA; TISSUE HEART VALVE Back to Search Results
Model Number LXA23
Medical Device Problem Code Gradient Increase (1270)
Health Effect - Clinical Codes Pulmonary Insufficiency (2022); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)
Date of Event 11/07/2016
Type of Reportable Event Serious Injury
Event or Problem 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.
 
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Brand Name
MITROFLOW LXA
Common Device Name
TISSUE HEART VALVE
Manufacturer (Section D)
LIVANOVA CANADA CORP.
5005 north fraser way
burnaby, bc V5J 5 M1
CA  V5J 5M1
MDR Report Key8834805
Report Number1718850-2019-01044
Device Sequence Number16829863
Product Code LWR
UDI-Device Identifier00896208000115
UDI-Public(01)00896208000115(240)LXA23(17)160430
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2016
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/03/2019
Report Date (Section F) 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
Operator of Device Health Professional
Device Expiration Date04/30/2016
Device Model NumberLXA23
Device Catalogue NumberLXA23
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/03/2019
Device Age67 MO
Event Location Hospital
Date Report to Manufacturer07/03/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age38 YR
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