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

Model Number	11500A25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury

• Brand Name: 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2 - m2202l; irvine, CA 92614 ; +1(949)250-3859
• MDR Report Key: 50740224
• Report Number: 2015691-2026-18489
• Device Sequence Number: 16029448
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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
• Device Model Number: 11500A25
• 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: 08/18/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 05/21/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 44 YR
• Patient Sex: Male