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

Model Number	LXA21
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	11/16/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.Tavi performed.
Event or Problem Description
Received information from sure avr registry about subject: (b)(4), a (b)(6) -year old, female patient.On (b)(6) 2011, a mitroflow lxa21 was implanted via median sternotomy.No concomitant procedure was performed.The site indicated ae 1 - valve related serious adverse event: non-structural dysfunction / other non structural dysfunction: early degeneration of the aortic valve prosthesis.Mixed valvulopathy complicated by systolic-diastolic left ventricular failure, that occurred on (b)(6) 2015.The site indicated ae 3 - reintervention / other: degeneration of the valve / transcatheter valve replacement, that occurred on (b)(6) 2016.Upon review of the sure-avr database a second sae occurred.Sae 2 - cancer: adenocarcinoma of the cardia, which occurred on (b)(6) 2017.This event was deemed not device related by the site.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa21, s/n # (b)(6), , as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa21 mitroflow aortic pericardial heart valve at the time of manufacture and release.
Additional Manufacturer Narrative
The manufacturer has made several attempts to retrieve additional event information and has not received any follow-up.Because the device is not available and no additional information was received no further investigation is possible at this time and the root cause of the event cannot be determined.Based on the information available the patient re-intervention was consequent of a structural valve deterioration leading to valve insufficiency.The root cause of this structural valve deterioration is unknown.If additional information is received the manufacturer will reassess the investigation.

• Brand Name: MITROFLOW LXA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 8097936
• Report Number: 3004478276-2018-00344
• Device Sequence Number: 2015727
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)160430
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2019

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: LXA21
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/12/2018; 01/17/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/07/2019; 01/17/2019
• 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: 84 YR
• Patient Weight: 70