MAUDE Adverse Event Report: LIVANOVA CANADA CORP MITROFLOW LXA AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVES

Model Number LXA19

Device Problems Degraded (1153); Off-Label Use (1494)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Pulmonary Insufficiency (2022); Pulmonary Valve Stenosis (2024)

Event Date 09/19/2019

Event Type  Injury  

Event Description

Received information from the device tracking department regarding a recent explant of a mitroflow lxa19.The device was implanted on (b)(6) 2013 and was explanted on (b)(6) 2019.The explant of the device was due to steno-insufficiency and dysfunction of the device.A new valve from a different manufacturer was implanted.No other information is presently available.

Manufacturer Narrative

Based on the information available, and since the device was not returned, a definitive root cause for the reported event cannot be established.Structural valve deterioration is listed as a possible adverse event in the mitroflow lxa ifu.Furthermore, the following notes exist in the sections "contraindications" and "specific patient population" of the ifu: clinical experience reported in medical literature suggests that juvenile patients, [.] or patients who are 55 years of age or less may experience accelerated calcification of bioprosthetic heart valves.[.] medical literature indicates that valve replacement in children may require subsequent valve replacement procedures as a result of normal cardiac tissue development.The event is, therefore, a known inherent risk of the device.It should be noted that the device was implanted in the pulmonary position.Per the "indications" section of the ifu, "the mitroflow valve is intended for the replacement of malfunctioning native or prosthetic aortic valves".As such, the decision to implant the device in a pulmonary position was made off-label.

Event Description

Received information from the device tracking department regarding a recent explant of a mitroflow lxa19 in (b)(6) 2019.The device was implanted on (b)(6) 2013 in the pulmonary position.The indications for the re-do surgery were: pulmonary valve insufficiency and right ventricular dilation after earlier repair of tetralogy of fallot.At two years old, the patient had striking right ventricular dilation and underwent placement of a 19 sorin mitraflow bioprosthetic valve ((b)(6) 2013), which has become dysfunctional.The tricuspid valve also required earlier repair and has again become insufficient.On (b)(6) 2019, a re-do surgery was performed due to prosthetic pulmonary valve insufficiency and stenosis, left pulmonary artery stenosis with stent and tricuspid valve regurgitation.After the excision of the old pulmonary valve prosthesis, a 22mm pulmonary homograft valve was implanted.A good postoperative outcome is reported for the patient.A further visit was performed on (b)(6) 2019, and the patient was reportedly well, with no concerns.

• Brand Name: MITROFLOW LXA AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9351485
• MDR Text Key: 170791245
• Report Number: 1718850-2019-01179
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)170930
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/24/2019,12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: LXA19
• Device Catalogue Number: LXA19
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/24/2019
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2019
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7 YR