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

Model Number	11400M
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Coronary obstruction/occlusion (4871)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the event description, "it was learned through implant patient registry and investigation that a patient with a 29mm 11400m mitral valve was explanted at implant due to left coronary artery obstruction.The explanted valve was replaced with a 29mm 11400m valve." the subject device was not returned for evaluation as there was no allegation towards it.No images were available but medical records were provided.As a result of the investigation, there was no allegation or confirmation of an edwards manufacturing defect.A device history record (dhr) review was performed, and no relevant non-conformances 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.Based on the information available, the reported ''left coronary artery obstruction" was confirmed via medical records and the most likely root cause is patient/procedural factors as the patient had "extensive erosion into (mitral) annulus from the prior valve with malpositioning identified." as mentioned per the medical records, "the left circumflex coronary artery appeared to be compromised adjacent to the 11400m mitral valve prosthesis" upon initial implant of the subject device and was explanted to reinforce some areas of the left atrium "due to the destruction of the previous transcatheter valve." 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 learned through implant patient registry and investigation that a patient with a 29mm 11400m mitral valve was explanted at implant due to left coronary artery obstruction.The explanted valve was replaced with a 29mm 11400m valve.Per medical records, the patient underwent 3rd time redo mitral valve explant of prior non-edwards transcatheter valve.There was extensive erosion into annulus from the prior non-edwards transcatheter valve with malpositioning identified.A 29mm 11400m mitris mitral valve was implanted and tricuspid valve repair was performed.Upon separating from cpb there was concern about the left circumflex coronary artery.Coronary angiogram was performed and the left circumflex coronary artery appeared to be compromised adjacent to the 11400m mitral valve prosthesis.Bypass was restarted and left atrium was reopened.The 29mm 11400m valve was explanted and a new 29mm 11400m valve was implanted.The left atrium was reinforced in some areas due to the destruction of the previous transcatheter valve.An intra-aortic balloon pump (iabp) was inserted for biventricular function and then ecmo was placed for cardiovascular and pulmonary support.He patient tolerated the procedure and returned to the intensive care unit in stable condition.It was learned that patient expired on pod#3 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.

• 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: jason reves ; 1 edwards way; mle fl2; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24906143
• Report Number: 2015691-2026-14437
• Device Sequence Number: 21300870
• Product Code: LWR
• UDI-Device Identifier: 00690103205558
• UDI-Public: (01)00690103205558(17)300129(11)250130
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 04/06/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female