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

Model Number	11400M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional manufacturer narrative: due diligence attempts were made to gather additional information regarding a device failure mode and for product return.There has been no response at this time.Additional information is not available at this time.Patient medical records were not provided by the hospital for review, or the medical records provided do not clarify the device failure mode.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, a definitive root cause cannot be conclusively determined.Per the instructions for use (ifu), reoperation/explant are known potential adverse events associated with bioprosthetic cardiac valves and annuloplasty rings.The device history record (dhr) was not reviewed as no information regarding a device failure mode was provided.Therefore, a review of manufacturing and/or device component issues that may have contributed to the reported event is unable to be performed.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.
Event or Problem Description
It was reported via the implant patient registry that a 31mm 11400m mitral valve, implanted in the tricuspid position, was explanted after an implant duration of two (2) years, nine (9) months due to unknown reason.The explanted valve was replaced with a 29mm 11400m valve.The implantation data card indicated that the patient was taken to recovery post procedure.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional 'customer complaint'.The information reported may or may not be related to the edwards device.
Event or Problem Description
It was reported via the implant patient registry that a 31mm 11400m mitral valve, implanted in the tricuspid position, was explanted after an implant duration of two (2) years, nine (9) months due to endocarditis.The explanted valve was replaced with a 29mm 11400m valve.Per medical records, the patient underwent redo mvr with a 29mm 11400m valve.Post cardiopulmonary bypass, there was a mild-moderate perivalvular leak was noted on the anterior surface.Decision was made to leave it alone due to it being in a difficult area to fix.Protamine was administered and excellent hemostasis was found throughout the field.The patient was taken to the icu in stable condition having tolerated the procedure well.There were no complications apparent.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated section b5 h11: corrected data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 23830674
• Report Number: 2015691-2025-10273
• Device Sequence Number: 12035391
• Product Code: LWR
• UDI-Device Identifier: 00690103205565
• UDI-Public: (01)00690103205565(17)240608(11)220609
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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 Expiration Date: 06/08/2024
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2022
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 32 YR
• Patient Sex: Female