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

Model Number	11400M
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: 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 a 29mm 11400m valve, implanted in mitral position, is under evaluation for a valve-in-valve procedure after an implant duration of 2 years and 11 months due to unknown reason.
Event or Problem Description
It was reported that a patient with a 29mm 11400m valve, implanted in mitral position, is under evaluation for a valve-in-valve procedure after an implant duration of 2 years and 11 months due to thrombus and high gradient (mg 21mmhg).The patient presented with acute on chronic diastolic heart failure.Per medical records, patient was admitted for acute on chronic heart failure/anasarca.Bioprosthetic mitral valve now with thrombus - on coumadin/heparin gtt.Consult with ic for tmvr.Long-term prognosis is poor.
Additional Manufacturer Narrative
Bioprosthetic valve thrombosis (bpvt) is the formation of blood clots on the valve, resulting in dysfunction that is potentially life-threatening.It is often diagnosed early post-operation but can occur at any time.Bpvt is a significant cause of valve failure, presenting either clinically with clear symptoms or subclinically without noticeable symptoms but still affecting valve function.The risk factors for bpvt include patient-specific conditions such as renal insufficiency, cancer, obesity, diabetes mellitus, smoking, the use of oral contraceptives, genetic defects, subtherapeutic anticoagulation, and autoimmune conditions such as antiphospholipid syndrome (aps) and systemic lupus erythematosus (sle).Thrombosis is a complex process influenced by the interaction between the patient and the device, as well as procedural factors such as valve size, implantation techniques, or interactions with other devices used during open-heart surgeries.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 dhr review was performed, and no related manufacturing nonconformances were identified.The most likely cause is patient factors, including coronary artery disease, hyperlipidemia, chronic kidney disease, diabetes mellitus, and smoking.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If new information becomes available, a supplemental report will be submitted.Updated sections: b5, b7, and h6 (clinical code, device code, type of investigation, investigation finding, and investigation conclusion).

• 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; irvine, CA 92614 ; 9492500222
• MDR Report Key: 21990408
• Report Number: 2015691-2025-03678
• Device Sequence Number: 8388867
• Product Code: LWR
• UDI-Device Identifier: 00690103205558
• UDI-Public: (01)00690103205558(17)240210(11)220210
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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 Expiration Date: 02/10/2024
• Device Model Number: 11400M
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 02/10/2022
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Female