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

Model Number	11400M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification that a valve model 11400m31 implanted in mitral was showing a mean transvalvular gradient of 5.8mmhg with normal leaflet mobility and no transvalvular regurgitation on a control transthoracic echocardiogram (tte) due to endocarditis after an implant duration of forty-nine (49) days.As reported the patient was asymptomatic and still on marcumar tratment when the high gradient were noticed.As reported, there were no signs of thrombus in tte.The endocarditis episode was managed with appropriate antibiotic therapy and resolved without the need for reintervention.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the subject device is not available for evaluation as it remains implanted in the patient.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.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b3, b5, b7, h6 (clinical code and type of investigation).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.
Event or Problem Description
Per the report received from germany, this valve model 11400m31 implanted in mitral position was showing a mean transvalvular gradient of 7-8mmhg due to endocarditis caused by staphylococcus epidermis after an implant duration of fifty-five (55) days.The patient had limited exercise capacity and dyspnea on exertion (nyha ii-iii) at the beginning but became asymptomatic.Appropriate antibiotic therapy was started.The patient was admitted to the clinical for a surgical intervention for the diagnosed early prosthetic endocarditis the blood cultures immediately before the planned surgery (during the antibiotic-free window) remained negative.Transesophageal echocardiogram (tee) showed, consistent with the patient's clinical status, an improvement of the local findings with hardly detectable deposits on the mitral valve prosthesis after 6 weeks of antibiotic.A conservative approach was chosen.Antibiotic therapy was discontinued, and the patient was discharged to outpatient care under supervision without the need for reintervention.
Additional Manufacturer Narrative
Initially it was reported that a valve model 11400m31 implanted in mitral was showing a mean transvalvular gradient of 5.8mmhg with normal leaflet mobility and no transvalvular regurgitation on a control transthoracic echocardiogram (tte) due to endocarditis after an implant duration of forty-nine (49) days.However, through investigation it was learned that the source of infection was staphylococcus epidermis.In this case, this is an early endocarditis and the source of infection is staphylococcus epidermis.However, sterilization information review for edwards lifesciences heart valves was received and it was concluded that the bioprosthetic valve, as supplied by edwards lifesciences, would not be the source of the characterized bacterial isolate from the infection, as it would not survive the terminal sterilization process after manufacture.Thus, not reportable.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• 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: saurav singh ; 1 edwards way; mle fl2 office; irvine, CA 92614 ; 9492506615
• MDR Report Key: 23407147
• Report Number: 2015691-2025-08868
• Device Sequence Number: 8853792
• Product Code: LWR
• UDI-Device Identifier: 00690103205565
• UDI-Public: (01)00690103205565(17)260117(11)240118
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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 Expiration Date: 01/17/2026
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 01/09/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2024
• 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: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG