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

Model Number	11400M29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Additional narrative: thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots forming on the device/graft.These clots could significantly impact the function of the valve resulting in harm.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 that a patient with a 11400m 29mm valve in tricuspid position is being evaluated for a valve-in-valve procedure after an implant duration of 1 year, 8 months due to severe regurgitation, mild halt, with motion restriction.The patient presented with worsening dyspnea, fatigue, and lower extremity edema.Per medical records, ct imaging demonstrated tricuspid valve with mild low-attenuating leaflet thickening of all three leaflets with restricted motion and lack of central coaptation resulting in significant regurgitation.No globular thrombus along the valve was seen.Cardiology note indicates that despite anticoagulation with warfarin, the patient continues to have severe regurgitation and worsening symptoms.
Event or Problem Description
It was reported that a patient with a 11400m 29mm valve in tricuspid position underwent a valve-in-valve procedure after an implant duration of 1 year, 8 months due to severe regurgitation, mild halt, with motion restriction.The patient presented with worsening dyspnea, fatigue, and lower extremity edema.A 9755rsl 29mm was implanted successfully.
Additional Manufacturer Narrative
H11.Additional narrative.Updated b3, b5, d4, h4, and h6.Subclinical leaflet thrombosis (slt) is described as a thin layer of thrombus that can involve one or all three leaflets, with typical appearance on mdct as a hypo-attenuating defect of the leaflets, also called hypo-attenuating leaflet thickening (halt) (figure2.).Reduced leaflet motion (rlm) is also associated with slt, as there is a decreased mobility of one or more leaflets of the valve.The mechanisms behind slt largely involve overactivation of the coagulation cascade pathway and disrupted hemodynamics through the bioprosthesis, the sinus of valsalva, and bioprosthetic valve leaflets.A dhr review was performed, and no related manufacturing nonconformances were identified.The most likely cause is patient factors.

• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 21708727
• Report Number: 2015691-2025-02300
• Device Sequence Number: 9941967
• Product Code: LWR
• UDI-Device Identifier: 00690103205558
• UDI-Public: (01)00690103205558(17)270215(11)230216
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/08/2025

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: 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female