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

Model Number	11400M29
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 29mm 11400m mitral valve was explanted at implant due to left ventricular rupture caused by possible contact of the stent post with the left ventricle.During a mitral valve replacement procedure via right anterior thoracotomy, after implantation of the device, left ventricular rupture occurred.The rupture was identified before decannulation.During surgery, the approach was converted to a median sternotomy for device exchange.After the device explant, left ventricular reconstruction was performed, and a non-edwards mechanical valve was implanted as a replacement.The patient outcome was not provided.The surgeon commented that the cause of the event was not clear, but there was a possibility that the stent post came into contact with the left ventricle and contributed to the rupture; therefore, a mechanical valve with no stent posts was selected as the replacement device.
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation as it was discarded.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 events.Trends are monitored on a the investigation is still in progress; therefore, a conclusion has yet to be established.
Additional Manufacturer Narrative
Updated sections: g3, g6, h2, h6 type of investigation, investigation findings, and investigation conclusions.A device history record (dhr) review was performed, and no relevant non-conformances were identified.A lot history review (lhr) was performed which did not identify any similar complaints.A complaint history review (chr) was conducted and two (2) similar complaints were identified due to operational context.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.Per the event description, "it was reported that a 29mm 11400m mitral valve was explanted at implant due to left ventricular rupture caused by possible contact of the stent post with the left ventricle.During a mitral valve replacement procedure via right anterior thoracotomy, after implantation of the device, left ventricular rupture occurred.The rupture was identified before decannulation." the subject device was not returned for evaluation as it was discarded.No pictures or medical records were provided.There were no images which were provided.Per information included as part of the event description "the surgeon commented that the cause of the event was not clear, but there was a possibility that the stent post came into contact with the left ventricle and contributed to the rupture; therefore, a mechanical valve with no stent posts was selected as the replacement device." there was no allegation of a device malfunction.Based on the information available, the complaint is unable to be confirmed, and a definitive root cause is unable to be determined, although procedural factors likely contributed.There is no allegation of a device malfunction and an edwards defect has not been confirmed.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24030108
• Report Number: 2015691-2026-10329
• Device Sequence Number: 9014744
• Product Code: LWR
• UDI-Device Identifier: 00690103205558
• UDI-Public: (01)00690103205558(17)271005
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 11400M29
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown