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

Model Number	9755RSL23A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist (fcs), during a tavr procedure with a 23mm sapien 3 ultra resilia valve, a bent tine was observed on the nc side of the thv before deployment.Implanter chose to slowly deploy and the tine mostly straightened out and deployment/implant was a success.It was suggested that the crimped valve interacted with the pigtail catheter.The sheath and delivery system were removed as a single unit.Per additional information provided by the fcs, there were difficulties during the crimping phase.The patient had mild tortuosity, and mild calcification.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for additional information from a product investigation.The following sections of this report have been updated: b4, g3, g6, h2, and h6.Frame damage was unable to be confirmed due to unavailability of returned device nor relevant imagery provided.A review of the dhr review did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.As reported, ''during a tavr procedure with a 23mm sapien 3 ultra resilia valve, a bent tine was observed on the nc side of the thv before deployment.It was suggested that the crimped valve interacted with the pigtail catheter.'' additional response from fcs also reported that ''the resistance was after alignment in the descending.'' in this case, following valve alignment, a non-edwards device (pigtail catheter) interacted with the crimped valve on the delivery system.It is possible that a frame strut caught on the pigtail catheter.If excessive force was applied during this interaction, it could have resulted in the reported bent frame.As such, available information suggests that procedural factors (interaction with non-edwards device) may have contributed to the complaint event.The ifu and training manuals have been reviewed, and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA 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: 24643607
• Report Number: 2015691-2026-13347
• Device Sequence Number: 21272465
• Product Code: NPT
• UDI-Device Identifier: 00690103215809
• UDI-Public: (01)00690103215809(17)281021(11)251022
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 9755RSL23A
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/30/2026
• 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
• Patient Sex: Unknown