MAUDE Adverse Event Report: EDWARDS LIFESCIENCES MITRIS RESLIA 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	05/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the subject device is not available for evaluation, as it was discarded on-site.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 mitral valve, was explanted after an implant duration of 1 year, 6 months due to thrombosis.The explanted valve was replaced with another 29mm 11400m valve.The device is not available for return.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: d4 (expiration date), g3, g6, h2, h4, h6 (type of investigation, investigation findings, and investigation conclusions).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.A dhr review was performed, and no related manufacturing nonconformances were identified.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.The most likely cause is patient factors.
Event or Problem Description
It was reported and learned through investigation that a patient with a 29 mm 11400m mitris resilia mitral valve, was explanted after an implant duration of 1 year, 6 months due to vegetation/clots, thrombosis, and severe mitral stenosis.The explanted valve was replaced with a non-edwards device.The patient was discharged on pod #4.The device is not available for return.Per the medical records, the patient presented with sepsis, an elevated white blood cell count, hemoptysis, and pneumonia.The patient was found with severe mitral stenosis with extensive vegetations/clots on the mitral valve leaflets and annulus.The patient underwent a redo mvr.Intraoperatively, large, organized clots white in appearance were found adhered to the annulus.Two distinct masses were also identified: one on the anterior leaflet and one on the posterior leaflet.Additionally, a thick layer of organized thrombus or vegetation was observed on the undersurface of the leaflets.The valve was excised, debrided and non-edwards device was implanted.The patient was left the or stable condition and was discharged on pod #4.Hospital pathology report: specimen a: tissue displays a slights amount of red granular adherent soft tissue overlying the three cusps.There were tan-white to red rubbery tissue fragments and a slight amount of intermixed clotted blood.Specimen b: mitral valve vegetation consists of tan-red irregular shaped portion of rubbery tissue.Image evaluation: customer report of thrombosis was confirmed through image evaluation.One color image of explanted valve from outflow aspect was provided.Valve appeared to have thrombotic-like material encroaching over the surfaces of all three leaflets.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b5, b7, g3, g6, h2, h6 (clinical code, type of investigation).

• Brand Name: MITRIS RESLIA 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: 22289637
• Report Number: 2015691-2025-05007
• Device Sequence Number: 8373855
• Product Code: LWR
• UDI-Device Identifier: 00690103205558
• UDI-Public: (01)00690103205558(17)240511(11)220512
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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: 05/11/2024
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 07/21/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/16/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2022
• 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; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male