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

Model Number	11400M27
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: additional narrative, surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was not returned for evaluation, as it remains implanted.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported and learned from medical records, that a 27mm 11400m mitris resila mitral valve in tricuspid position was disabled via a valve-in-valve procedure after an implant duration of 2 years, 1 month due to moderate to severe regurgitation and significant stenosis.A 26mm sapien 3 ultra resilia transcatheter valve was implanted.Per medical records the patient presented with doe, fatigue.Tee demonstrated moderate to severe tricuspid regurgitation and there was significant tricuspid stenosis.The patient underwent tavr in which a 26mm sapien 3 ultra resilia transcatheter valve was deployed smoothly into the foramen of the 27mm 11400m mitrits resilia.The hemodynamics were good; tee showed a wide-open valve with a mean gradient 2 mmhg.There were no other issues.The patient tolerated the procedure well and was transferred back to the room in good condition.
Additional Manufacturer Narrative
H11.Additional narrative updated h6.Regurgitation is a common manifestation of bioprosthetic valve and valved conduit dysfunction.Common intraoperative factors that may cause or contribute to acute post-procedural regurgitation include device distortion; device interaction with patient anatomy or other devices; leaflet damage, and incorrectly sized valve seated.Non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis may also cause or contribute to acute post-procedural regurgitation.Complaints reported with regurgitation as the primary complaint code are not typically attributed to manufacturing-related nonconformances.A device history record (dhr) review was performed, and no relevant non-conformances were identified.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient factors, including off-label implant position and patients medical history of smoking and endocarditis.

• Brand Name: EDWARDS 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: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21970989
• Report Number: 2015691-2025-03592
• Device Sequence Number: 8475908
• Product Code: LWR
• UDI-Device Identifier: 00690103205541
• UDI-Public: (01)00690103205541(17)241019(11)221020
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 06/11/2025

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: 11400M27
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 29 YR
• Patient Sex: Female