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	Obstruction/Occlusion (2422)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 33mm 11400m mitral valve was explanted after an implant duration of 2 days due to lvot obstruction with high gradients.The explanted valve was replaced with a 29mm 11400m valve.The patient was in stable condition post procedure.Per additional information, the patient had high lvot gradient and lvot obstruction due to sub valvular apparatus and anterior leaflet obstruction.The surgeon explanted the 33mm 11400m excised the anterior leaflet and sub valvular apparatus and implanted 29mm 11400m.
Additional Manufacturer Narrative
Updated sections: g3, g6, h6 type of investigation, investigation findings, and investigation conclusions.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 complaint is able to be confirmed via medical records and the most likely root cause is procedural factors.Per the medical records, the lvot obstruction and high gradients after the short 2-day implant duration were due to the patient's subvalvular apparatus and anterior leaflet obstruction.Based on the fact that the subvalvular apparatus and anterior leaflet were excised prior to the replacement valve and the replacement valve was sized down from 33mm to 29mm of the same 11400 model prior to its successful implant, the patient's native anatomy and the surgeon's device implantation approach contributed to the reported lvot obstruction and high gradients shortly after initial implant.An edwards defect has not been confirmed.
Additional Manufacturer Narrative
Updated sections: b5, b7, g3, g6, h6 type of investigation.
Event or Problem Description
It was reported that a patient with a 33mm 11400m mitral valve was explanted after an implant duration of 2 days due to lvot obstruction with high gradients.The explanted valve was replaced with a 29mm 11400m valve.The patient was in stable condition post procedure.Per medical records and additional information, the patient had high lvot gradient and lvot obstruction due to subvalvular apparatus and anterior leaflet obstruction.Tee revealed lvot obstruction possibly related to a papillary head near the av annulus.The surgeon explanted the 33mm 11400m excised the anterior leaflet and sub valvular apparatus and implanted 29mm 11400m.The intraoperative tee showed no significant lvot obstruction and no perivalvular leak.

• Brand Name: MITRIS RESILIA MITRAL VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvinbe 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: 23058341
• Report Number: 2015691-2025-07596
• Device Sequence Number: 8765665
• Product Code: LWR
• UDI-Device Identifier: 00690103205572
• UDI-Public: (01)00690103205572(17)270921(11)230922
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2025

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 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 10/27/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/20/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2023
• 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; Life Threatening; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male