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

Model Number	11500A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Insufficient Information (4580)
Date of Event	01/26/2026
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.
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 of 4 months, 26 days due to unknown reason.Unknown what valve was implanted in replacement.Per usage record bentall procedure performed.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
Updated sections: b5, b7, g3, g6, h2, h6 health effect - clinical code, device code(s), and type of investigation.
Event or Problem Description
It was learned through implant patient registry and investigation that a patient with a 25mm 11500a aortic valve was explanted after an implant duration of 4 months, 26 days due to partial dehiscence from non-coronary sinus pseudoaneurysm causing pvl.The device was replaced with a 27mm 11500a valve.Per medical records, the patient was admitted for heart failure due to pvl with no active infection.The patient underwent redo-avr with a 27mm 11500a inspiris valve and sinus root replacement with a 30mm graft.The prosthetic av was partially dehisced at the noncoronary sinus due to pseudoaneurysm.The patient was transferred to cvicu and discharged on pod#12.
Additional Manufacturer Narrative
Updated sections: g3, g6, h2, h6 type of investigation, investigation findings, and investigation conclusions.Dehiscence refers to the separation of the prosthetic valve from the surrounding heart tissue, typically at the sewing ring where the valve is sutured to the annulus.This separation can cause blood to leak around the valve (paravalvular regurgitation), reducing its effectiveness and straining the heart.This generally occurs due to patient-related anatomical factors, such as irregular anatomy, which may lead to increased stress on the surrounding tissue over time.This is often as a result of successive dilation of cardiac structures caused by progressions of valvular disease.A device history record (dhr) review was performed, and no relevant non-conformances were identified.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 history of aortic valve endocarditis, and chronic kidney disease (ckd).

• 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; irvine, CA 92614 ; 9492503859
• MDR Report Key: 24477446
• Report Number: 2015691-2026-11642
• Device Sequence Number: 10277272
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)300325(11)250326
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 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,Followup
• Report Date (Section B): 04/14/2026

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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/16/2026; 04/13/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/11/2026; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male