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

Model Number	11400M27
Medical Device Problem Codes	Calcified (1077); Thickening of Material (4056); Device Stenosis (4066)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a patient with an 11400m mitris valve of unspecified size was placed under evaluation for redo mitral valve replacement after an implant duration of two (2) months due to mitral stenosis.Patient returned after approximately one (1) month post-op while on eliquis and was admitted for heparin drip and intervention.Patient was put on heparin drip and coumadin and valve gradient was reduced to 9mmhg.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: a1, a2, a3, b4, b5, g3, g6, h2.
Event or Problem Description
It was reported that a patient with an 11400m mitris valve of unspecified size was placed under evaluation for redo mitral valve replacement after an implant duration of two (2) months due to mitral stenosis with a gradient of 14mmhg.Patient returned after approximately one (1) month post-op while on eliquis and was admitted for heparin drip and intervention.Patient was put on heparin drip and coumadin and valve gradient was reduced to 9mmhg.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated sections g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions) stenosis is a common manifestation of bioprosthetic valve and valved conduit dysfunction and has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Bioprosthetic device stenosis is typically related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing deficiency.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.A definitive root cause is unable to be determined, however, patient factors likely caused or contributed.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.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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: updated: a2 (age), b4, g3, g6, h2, h6.
Event or Problem Description
It was reported that a patient with an 11400m mitris valve of unspecified size was placed under evaluation for redo mitral valve replacement after an implant duration of two (2) months due to mitral stenosis with a gradient of 14mmhg.Patient returned after approximately one (1) month post-op while on eliquis and was admitted for heparin drip and intervention.Patient was put on heparin drip and coumadin and valve gradient was reduced to 9mmhg.Additional information was received and after an implant duration of eight (8) months the patient was placed under evaluation for valve-in-valve intervention due to halt.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, b5, g3, g6, h2, h6.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6.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).Subclinical leaflet thrombosis (slt) is described as a thin layer of thrombus that can involve one or all three leaflets, with typical appearance on mdct as a hypo-attenuating defect of the leaflets, also called hypo-attenuating leaflet thickening (halt).A device history record (dhr) review was performed, and no relevant non-conformances were identified.Halt is a known potential risk associated with the use of bioprosthetic heart valves, which is included in the instructions for use (ifu), and there is no evidence to suggest a manufacturing non-conformance or defect contributed, thus no further evaluation is needed.Neither a product risk assessment (pra) nor corrective or preventive actions (capa/scar) are required at this time because no triggers are met.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Common Device Name: 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; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21692239
• Report Number: 2015691-2025-02250
• Device Sequence Number: 8849777
• Product Code: LWR
• UDI-Device Identifier: 00690103205541
• UDI-Public: (01)00690103205541(17)271214(11)231215
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/06/2026

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
• Device Model Number: 11400M27
• Was Device Available for Evaluation?: No
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 05/07/2025; 09/02/2025; 10/24/2025; 12/19/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/17/2025; 05/07/2025; 09/26/2025; 11/18/2025; 01/06/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female