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

Model Number	11500A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a 29mm 11500a valve, implanted in the pulmonic position, underwent a valve-in-valve procedure after an implant duration of 4 years, 7 months due to severe pulmonic insufficiency.The patient presented with exercise intolerance.The tpvr was successfully performed with a 29mm 9755rsl valve.Per medical records, the patient underwent tpvr/viv and the surgical valve ring was successfully fractured with a 28mm true balloon and 10mm advance 35 lp balloons.The patient tolerated the procedure well and was transferred to recovery room post procedure.On pod #1, the patient was discharged home.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: 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.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
Based on the information available, the device was intentionally used outside the way it was designed and intended.The performance, safety, efficacy, longevity, and durability of bioprosthetic valves have not been determined when the product is used outside the scope of its intended use and/or its studied population.Regurgitation is a common manifestation of bioprosthetic valve and valved conduit dysfunction.Common intraoperative factors that may cause or contribute to acute post-procedural regurgitation include device distortion; device interaction with patient anatomy or other devices; leaflet damage, and incorrectly sized valve seated.Non-structural valve dysfunction (nsvd), endocarditis and/or thrombosis may also cause or contribute to acute post-procedural regurgitation.Complaints reported with regurgitation as the primary complaint code are not typically attributed to manufacturing-related nonconformances.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient factors, including tetralogy of fallot and patient age at time of implant.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.

• 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; mle fl2- office m2013; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24339669
• Report Number: 2015691-2026-11119
• Device Sequence Number: 21275422
• Product Code: LWR
• UDI-Device Identifier: 00690103195019
• UDI-Public: (01)00690103195019(17)221217(11)181218
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/18/2026

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: 12/17/2022
• Device Model Number: 11500A
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2018
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 145 KG