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

Model Number	LXA23
Medical Device Problem Codes	Degraded (1153); 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
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa23, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa23 mitroflow aortic pericardial heart valve at the time of manufacture and release.The device is not available for return and no further information is available for the reported event.The manufacturer is unable to perform any further investigations.Structural valve deterioration is a known inherent risk of failure for biological implants.However, because no further investigations are possible the root cause cannot be established at this time.
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 35 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
• 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 Key: 8834814
• Report Number: 3004478276-2019-00229
• Device Sequence Number: 2824231
• Product Code: LWR
• UDI-Device Identifier: 00896208000115
• UDI-Public: (01)00896208000115(240)LXA23(17)160430
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2019

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 Date: 04/30/2016
• Device Model Number: LXA23
• Device Catalogue Number: LXA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR