MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9755RSL26A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist, during a right transfemoral transcatheter aortic valve replacement procedure to implant a 26 mm sapien 3 ultra resilia valve (s3ur), there was difficulty advancing the valve through the 14f esheath+ and the valve had a bent strut.It was noted that the right side access vessels were calcified and tortuous.There was slight difficulty inserting the esheath+ into the patient due to tortuosity.The esheath+ was not inserted at a steep angle.The vessel was dilated with a 16f kit dilator and the 14f esheath+ and dilator were inserted through.The esheath+ was also expanded with the 16f dilator.High push forces were experienced near the iliac, when the system was in the fully expandable portion of the esheath+.The operator was able to slide the esheath+ back slightly away from the tortuosity and then advance the valve through.It was noted that the s3ur valve had one inflow strut bent backwards.The s3ur valve was deployed with nominal volume.The strut remained in the bent position after deployment.A contrast runoff shot was taken to verify there were no injuries in the right iliac.The patient was in stable condition.Upon removal of the devices, it was noted that there was an elongated white scrape line in the blue portion of the esheath+.Per report, the bent strut were attributed to the s3ur valve hitting a difficult turn in the esheath+ while advancing the commander delivery system with sapien 3 ultra resilia valve.

• Brand Name: EDWARDS LIFESCIENCES SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 25125251
• Report Number: 2015691-2026-15017
• Device Sequence Number: 10642370
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)281123(11)251124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9755RSL26A
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• 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
• Patient Age: 86 YR
• Patient Sex: Male