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

Model Number	11500A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
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
Updated sections: g3, g6, h2, h6 type of investigation, investigation findings, and investigation conclusions.A dhr review was performed, and no related manufacturing nonconformances were identified.The complaint is unable to be confirmed.There is no evidence to suggest an edwards manufacturing defect.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.Per event description, "it was learned through implant patient registry and investigation that a patient with a 27mm 11500a aortic valve was explanted at implant to repair disruption of the aortic suture line.The explanted valve was replaced with a 27mm 11500a valve.The patient was in recovery post procedure." based on the information available, a definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.
Event or Problem Description
It was learned through implant patient registry and investigation that a patient with a 27mm 11500a aortic valve was explanted at implant to repair disruption of the aortic suture line.The explanted valve was replaced with a 27mm 11500a valve.The patient was in recovery post procedure.Per medical records, the patient had severe native ai/as with heart failure.The patient initially underwent avr with a 27mm 11500a valve and an iabp was placed to help support weaning from the bypass.Prior to weaning from bypass, there was some bleeding from the aortic suture line that was repaired with pledgeted sutures.Intraoperatively, patient had very fragile and friable tissue with heavy calcification of the native aortic valve.But after coming off bypass, there was partial disruption of the aortic suture line that was not amendable to repair off pump.Cpb was placed back and a bentall procedure was performed.The 27mm 11500a valve was explanted.There was noted to be partial separation of the anterior mitral leaflet near its insertion, demonstrating how fragile the patient's tissue was after seating the previous valve.A new 27 mm inspiris valve was implanted, and a 32 mm cardia root was constructed.When trying to wean from bypass this time, ventricular function was very diminished and an impella was placed.The patient was taken to the (b)(6) in critical condition.The patient later expired upon arrival in the icu.Discharged diagnosis was heart failure with reduced ejection fraction.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; 1 edwards way; irvine 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; irvine, CA 92614 ; 9492503859
• MDR Report Key: 25029691
• Report Number: 2015691-2026-14783
• Device Sequence Number: 10126535
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)301021(11)251022
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P150048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2025
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male