MAUDE Adverse Event Report: Edwards Lifesciences Edwards INSPIRIS RESILIA Aortic Valve; Heart-Valve, Non-Allograft Tissue

Model Number	11500A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 25mm 11500a25 aortic valve underwent a valve-in-valve procedure after an implant duration of 4 years, 7 months due to calcification.The patient presented with shortness of breath.The procedure was performed successfully with a 26mm 9755rsl transcatheter valve.
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.

• Brand Name: Edwards INSPIRIS RESILIA Aortic 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 ; +1(949)250-3859
• MDR Report Key: 50260177
• Report Number: 2015691-2026-17772
• Device Sequence Number: 10634993
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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 Expiration Date: 08/10/2025
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2021
• 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; Required Intervention; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male