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

Model Number	11400M
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the device was not returned for evaluation.Attempts to retrieve the device and additional information are in process.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.
Event or Problem Description
Per the report received from australia a valve model 11400m31 was explanted after two (2) days from mitral position due to "thrombus-like substance" found on leaflets leading to moderate regurgitation.As reported, the initial procedure was a ventricular septal defect (vsd) closure and postoperatively to this procedure, the patient was placed on extracorporeal membrane oxygenation (ecmo) and ultimately underwent a mitral valve replacement to reduce pressure on the vsd patch.Two days after the valve implant, the valve demonstrated regurgitation and an intravalvular leak, which was confirmed by ct imaging.There was no regurgitation noted immediately post 11400m valve implantation.The patient was taking aspirin at the time of the thrombosis diagnosis.In replacement, a non-edwards valve was implanted.The patient was noted as to be in stable condition.
Additional Manufacturer Narrative
Information added/updated to section d9, h3 and h6 (type of investigation) corrected data in section g1.H3: device evaluation: the device was returned for evaluation.Customer report of "thrombus-like substance" was confirmed.The x-ray demonstrated the wireform intact.As received, fibrin-like deposits were observed on the leaflets on both inflow and outflow aspects.Fibrin-like deposit were also observed between leaflets 1 and 3 and leaflets 2 and 3, creating a gap in the coaptation region.Minimal fibrin-like material/host tissue overgrowth was observed around the stent circumference on both inflow and outflow aspects.Sewing ring cloth had multiple cuts around the valve and exposed silicone of sewing ring.Multiple suture holes were visible around the sewing ring.H11: additional 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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard 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 device history record (dhr) review was performed, and no related manufacturing nonconformances were identified.Thrombosis is a condition in which blood coagulates and creates what is commonly known as blood clots.Thrombosis can cause life-threatening conditions requiring immediate medical attention.Bioprosthetic valve thrombosis (bpvt) is one category of bioprosthetic valve dysfunction and is an increasingly recognized complication of tissue valve prosthesis.Bpvt usually occurs late after implantation and can be further categorized into two subcategories: clinical valve thrombosis (cvt) and subclinical valve thrombosis (slt).Clinical valve thrombosis is defined as clinically apparent prosthetic valve dysfunction with the typical finding of an increased transvalvular gradient with a mobile mass/thrombus on the prosthetic heart valve as visualized by echocardiography or multi-detector computed tomography (mdct).There is no evidence to suggest a manufacturing non-conformance or defect contributed to the reported event.Based on the information available, the most likely cause is patient factors and the potential contribution of procedural hemodynamic perturbations, including ecmo associated low-flow states and closely timed repeat cardiopulmonary bypass exposures.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2 office; irvine, CA 92614 ; 9492503859
• MDR Report Key: 23700289
• Report Number: 2015691-2025-09714
• Device Sequence Number: 10216150
• Product Code: LWR
• UDI-Device Identifier: 00690103205565
• UDI-Public: (01)00690103205565(17)300212(11)250213
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

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 Model Number: 11400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 02/03/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male