MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS 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	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 26 mm sapien 3 ultra resilia valve, one of the valve struts was bent while the commander delivery system with valve was being advanced through the 14fr esheath+.There was difficulty advancing the delivery system with valve through the esheath+ and it appeared to have occurred at the transition from the strain relief to the sheath shaft/fully expandable portion of the esheath+.Once the delivery system with valve exited the esheath+, the bent valve strut was noted.The valve was deployed successfully.The delivery system was removed through the esheath+ and then the esheath+ was removed.The delivery system and esheath+ were intact with no damage observed.There was no patient injury.Imagery was received for evaluation.Per imaging evaluation, one (1) bent strut was located at the inflow side.
Additional Manufacturer Narrative
The investigation is ongoing.

• Brand Name: EDWARDS 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: 24941728
• Report Number: 2015691-2026-14556
• Device Sequence Number: 12159173
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)281123(11)251124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/21/2026

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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/21/2026
• 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 Sex: Male