MAUDE Adverse Event Report: LIVANOVA CANADA CORP MITROFLOW 12A AORTIC PERICARDIAL HEART VALVE; TISSUE HEART VALVES

Model Number 12A21

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Unspecified Infection (1930); Heart Failure (2206)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # 12a21, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4).The results confirmed that this valve satisfied all material, visual, and performance standards required for a 12a21 mitroflow aortic pericardial heart valve at the time of manufacture and release.

Event Description

On (b)(6) 2014, a male patient received a mitroflow 12a21 in aortic position.In (b)(6) 2019, a heart murmur was observed.After that, the patient was diagnosed with heart failure.On (b)(6) 2019, an aortic valve replacement was performed due to severe aortic regurgitation and infection.

Manufacturer Narrative

The returned prosthesis underwent visual inspection, x-ray exams and hysto-pathological analysis.Visual examination of the valve revealed a deformed prosthesis due to tears in all leaflets, which most likely caused valve insufficiency.Pannus overgrowth into inflow lumen caused a low degree of stenosis.There was no evidence of calcification or endocarditis in the returned valve.Cuspal tears without calcification are related to direct mechanical damage to the collagen structure during functional opening and closure of the cusp.Histological analysis showed the presence of lipid infiltration (cholesterol clefts) in the pericardial tissue.This lipid infiltration, as supported from the scientific literature, may contribute to localized leaflet stiffness, and if associated with a degeneration of collagen fibers, as detected in the samples from this valve, may also lead to leaflet tearing.Histological analysis also identified inflammatory cells.Based on the available information, it is not possible to draw a definitive conclusion on the reported event.It is possible that the patient¿s clinical conditions and risk factors (hypertension and hyperlipidemia) may have contributed to the structural valve deterioration observed in this mitroflow valve.It should be noted that structural valve deterioration is listed as a possible adverse event in the mitroflow ifu.The event is, therefore, a known inherent risk of the device.

Manufacturer Narrative

The event description and coding for the patient and the device have been adjusted based on the additional information received.The device was returned to the manufacturer and it was received on 09 oct 2019.The returned valve was received with pannus deposition on the inflow side and on the leaflets.One of the leaflets resulted torn and the sewing ring was deeply deuteriated.Further investigation is ongoing.

Event Description

On (b)(6) 2014, a male patient received a mitroflow 12a21 in aortic position.In (b)(6) 2019, a heart murmur was detected and, after that, the patient was diagnosed with heart failure.The device was visualized and severe aortic regurgitation was detected at the echo.Structural valve deterioration was confirmed for this case.On (b)(6) 2019, an aortic valve replacement was performed.The patient received an inspiris 21mm and a good outcome is reported after surgery.

• Brand Name: MITROFLOW 12A 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: 9126773
• MDR Text Key: 161309403
• Report Number: 1718850-2019-01094
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000023
• UDI-Public: (01)00896208000023(240)12A21(17)180228
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2019,12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 12A21
• Device Catalogue Number: 12A21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2019
• Date Manufacturer Received: 08/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR