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

Model Number	11500A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was learned through implant patient registry that a patient with a 25mm 11500a aortic valve was explanted after an implant duration 1 day due to unknown reasons.The explanted valve was replaced with a 25mm 11060a valved conduit.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional 'customer complaint'.The information reported may or may not be related to the edwards device.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H11: corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
It was learned through implant patient registry and medical records that a patient with a 25mm 11500a aortic valve was explanted at implant due to bleeding from aortic root area.The explanted valve was replaced with a 25mm 11060a valved conduit.Per medical records, the patient presented emergently with an acute type a aortic dissection with moderate aortic regurgitation and underwent emergent surgical repair with ascending aortic replacement.Intraoperatively, the ascending aorta and native aortic valve with moderate regurgitation were explanted and 25 mm 11500a inspiris aortic valve was implanted.However, due to uncontrolled bleeding from the aortic root with associated hematoma, the initially implanted 25 mm 11500a inspiris valve was explanted and a 25 mm 11060a valved conduit was implanted using bentall procedure.Following attempted separation from cardiopulmonary bypass, the patient developed post cardiotomy shock with severe ventricular dysfunction, necessitating initiation va ecmo.Post op tee showed severely reduced left ventricular systolic function, with the prosthetic valve well seated and functioning, and the patient was subsequently transferred to the cardiac icu for ongoing critical care management and was discharged on pod # (b)(6).Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional 'customer complaint'.The information reported may or may not be related to the edwards device.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; mle fl2; irvine, CA 92614 ; 9492506615
• MDR Report Key: 24603819
• Report Number: 2015691-2026-13217
• Device Sequence Number: 15843254
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)300611(11)250612
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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; Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male