MAUDE Adverse Event Report: EDWARDS LIFESCIENCES MITRIS RESILIA MITRAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11400M

Device Problems Gradient Increase (1270); Difficult to Open or Close (2921); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

Event Type  Injury  

Event Description

It was reported that a patient with a 11400m 25mm valve, implanted in mitral position, underwent a valve-in-valve procedure after an implant duration of 2 weeks.Echo indicated severe mv stenosis.It had appeared that one of the leaflets was frozen.Patient underwent ballooning of the valve with a 23mm true balloon.The leaflets started working and via tee the patient now has a mean gradient of 6mg.

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Leaflet immobility or leaflet restriction occurring over time, and not due to extrinsic physical interference, is a form of structural valve deterioration, which can result in significant regurgitation and/or stenosis.Tissue degeneration-related structural deterioration, either calcific or non-calcific, are common chronic failure modes for this type of bioprosthetic heart valve.Operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration.Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time.Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction related to a manufacturing deficiency.An engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and there is no evidence of a product failure with regard to design, reliability, or use error.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A capa/scar/pra is not required as there are no confirmed product or labeling non-conformances and no other triggers are met.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely contributed, including the patient being put on prolonged ecmo.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492500222
• MDR Report Key: 17999887
• MDR Text Key: 326446846
• Report Number: 2015691-2023-17044
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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
• Device Operator: Health Professional
• Device Model Number: 11400M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/12/2023
• Date Device Manufactured: 06/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male