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

Model Number	11500A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported and later learned that a patient with a 27mm 11500a inspiris resilia aortic valve in aortic position underwent a valve in valve procedure after an implant duration of 7 years, 4 months due to stenosis.Tavr was completed with a 26mm 9755rsl transcatheter valve.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: the dhr review was completed and there are no related ncrs.Engineering evaluation summary: per (b)(4), stenosis is a common manifestation of bioprosthetic valve and valved conduit dysfunction and has many potential root causes, including structural valve deterioration (svd), non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis.Bioprosthetic device stenosis is typically related to patient and/or procedural factors and is not typically an indication of a device malfunction related to a manufacturing deficiency.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.There is insufficient information available regarding patient or procedural factors known to cause or contribute to stenosis.Therefore, a definitive root cause cannot be conclusively determined.

• Brand Name: Edwards INSPIRIS RESILIA Aortic Valve
• Common Device Name: Heart-Valve, Non-Allograft Tissue
• Manufacturer (Section D): Edwards Lifesciences LLC; 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; mle fl2- office m2013; irvine, CA 92614 ; +1(949)250-3859
• MDR Report Key: 50812918
• Report Number: 2015691-2026-18658
• Device Sequence Number: 13314535
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 06/28/2020
• Device Model Number: 11500A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2018
• 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; Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male