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

Model Number	11500A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional h6 (type of investigation) code: labelling review h11: additional manufacturer narrative: this report serves as both the initial and final medical device report (mdr), incorporating the findings from the investigation.The device was not requested for return as there is no allegation of device deficiency and/or malfunction by end customer.Aortic tear may occur as a complication of cardiac surgery involving a diseased aortic root.Aortic tears are life threatening conditions that require urgent intervention.This event, or its consequence, is a known anticipated risk/potential adverse event included in the instructions for use (ifu).There is no evidence to suggest a manufacturing non-conformance or defect contributed to the reported event.Based on the information available, the most likely cause is patient and/or procedural factors, including pre-operative native tissue fragility and significant calcification of the aortic root.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
Edwards lifesciences maintains an implant patient registry (ipr).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".It was reported via the implant patient registry (ipr) that this 11500a23 valve was explanted at implant from the aortic position due to aortic root rupture.As reported, during the process of implanting the valve, a calcium bar was dislodged and the integrity of the root, which was very fragile and significantly calcified, was compromised.As the aortic root was not salvageable, it was decided to attempt a bentall procedure with an aortic conduit valve.Unfortunately, the patient did not survive.It was noted that the edwards device was not a contributing factor for the death of the patient.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jason reves ; 1 edwards way; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24936614
• Report Number: 2015691-2026-14553
• Device Sequence Number: 18823243
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)300219(11)250220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 04/11/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2025
• 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: Death
• Patient Age: 84 YR
• Patient Sex: Female