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

Model Number	11400M
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the device was not returned for evaluation, as it remains implanted.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 developed valve thrombus on pod #3 while on ecmo.Per the nurse practitioner, the thrombus was treated with tpa (iv thrombolytic).Per medical records, there was no evidence of valve thrombus/tpa.The patient underwent robotic mvr for flailed native leaflet/degeneration with severe mac.A 29mm 11400m valve was implanted, post procedure tee demonstrated a good functioning valve and no pvl.However, there was severe rv dysfunction/cardiogenic shock, the patient was placed on av-ecmo and transferred to the cardiac surgery icu in stable condition.On pod #3, the patient developed stroke; punctate age-indeterminate lacunar right infarct.Ct showed no evidence of acute transcortical infarction, hemorrhage, or mass lesion.Pod #5, the patient was taken back to the or for decannulation of ecmo and tolerated the procedure well without complications.The patient was discharged on pod #15.6 days later, outpatient echo showed mitral valve with a mean gradient of 10mmhg, there was no mention of prior thrombus.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions).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).Valve thrombosis 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.This event will be included in ongoing monitoring and trending.Based on the information available, the most likely cause is procedural factors including the use of artificial blood circulators such as extracorporeal membrane oxygenation (ecmo).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.H11: corrected data: h6 (component code).

• Brand Name: EDWARDS 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, LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24073879
• Report Number: 2015691-2026-10415
• Device Sequence Number: 18698688
• Product Code: LWR
• UDI-Device Identifier: 00690103205558
• UDI-Public: (01)00690103205558(17)300804(11)250805
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2026

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?: 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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: Other; Hospitalization; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG