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

Model Number	11400M
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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.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.H3: evaluation summary: customer report of bent valve was confirmed.X-ray demonstrated commissures 1 was bent inward.Sewing ring cloth was cut around leaflet 1 and expose the silicone underneath.No other visible inconsistencies were observed from the returned valve.
Event or Problem Description
It was reported that a 27mm 11400m mitral valve was explanted at implant due to frame distortion caused by interference from the previously implanted tav.Another 27mm 11400 mitral valve was implanted in replacement.Per medical records, the patient developed ms underwent mis-mvr.Intraoperatively after securing the first 27mm valve in place, the surgeon could see that the frame was somewhat distorted, more ovoid than circular.This distortion caused some tension on one of the leaflets causing a gap between the anterior lateral leaflet and the other 2 leaflets.There was significant transvalvular regurgitant leak.Decision was made to convert to a sternotomy approach and explant the valve.Then a new 27mm 11400m valve was implanted.As the last cor-knots were being secured the valve again took a distorted ovoid shape - the same distortion of the leaflet as seen previously (1st valve) occurred.To fix this the surgeon released one of the sutures with its cor-knot.The valve frame then became more circular and the gap between the leaflets disappeared.Post procedure tee showed excellent function of the well-seated valve and no pvl or transvalvular regurgitation.The patient was transferred to icu in stable condition and discharged on pod #6.The surgeon noted at the end of the case, the previous tav caused distortion of the mitral valve frame due to abutment of the tav through the aorto-mitral curtain.Distorted frame was seen on both valves which caused the leaflet gaps and led to regurgitant leak on the first valve.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6 (investigation findings, investigation conclusions).An edwards manufacturing defect has not been confirmed.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 for distortion of the valve during implant is included in the ifu.Based on the information available, the complaint for "frame distortion" was confirmed via medical records and evaluation of the returned product.The most likely root cause is procedural factors, as the surgeon noted at the end of the case that "the previous tav caused distortion of the mitral valve frame due to abutment of the tav through the aorto-mitral curtain" and the "distorted frame was seen on both valves "[used in the procedure]" which caused the leaflet gaps and led to regurgitant leak on the first valve." it is also possible that the sewing ring cloth damage observed upon product return could have resulted from handling during device explant.H11: corrected data: h6 (device code(s), type of investigation).

• 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; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24955920
• Report Number: 2015691-2026-14585
• Device Sequence Number: 10029929
• Product Code: LWR
• UDI-Device Identifier: 00690103205541
• UDI-Public: (01)00690103205541(17)300129(11)250130
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 05/28/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• 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: 03/28/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female