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

Model Number	9755RSL29A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs) during a right transfemoral transcatheter aortic valve replacement with a 29mm sapien 3 ultra resilia (s3ur) valve being placed in a non-edwards surgical valve when the 29mm commander delivery system (ds) was being inserted into the 16f esheath+ the insertion track was too tight and had resistance at the strain relief portion and thought to be damaged.Once an incision was made the ds was delivered easier.Due to the force going through the sheath the strut was bent had exited the sheath and was deployed in the annulus.The system came out through the sheath post deployment.The sheath and ds were removed, and a new sheath was prepped and used for possible post dilation.There was no difficulty withdrawing the sheath.The valve was successfully implanted.The perceived root cause of the resistance was the insertion track was not dilated enough.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2, h6: component code, type of investigation, investigation findings, investigation conclusions and conclusions in this section have been updated.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the instructions for use (ifu), training manuals and current risk mitigations have been reviewed.No inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Imagery was provided, the imagery provided showed that the strut appeared bent backwards at the inflow side of the valve on fluoro.Through extensive complaint investigations, events reporting resistance during delivery system insertion or advancement through the sheath with the s3u/s3ur valve configuration have not been linked to device malfunctions or manufacturing nonconformances.Historically, root causes for these events have been associated with multiple contributing factors, including patient conditions (vascular and non-vascular), procedural variables, and use related variability (e.G., technique, user error).These factors often interact and compound, potentially resulting in secondary device failures such as valve frame damage or compromised sheath and delivery system components as well as secondary complications affecting the delivery system.Notably, these secondary failures or complications are also not considered device malfunctions or manufacturing nonconformances, as they arise from the same complex interplay of external factors rather than inherent product defects.The complaint for frame damage was confirmed based on imagery provided for review.Available information suggests procedural factors (high push force) likely contributed to the event as it was reported that there was resistance during advancement, and ''due to the force going through the sheath, the strut was bent.'' high push force can lead to the valve struts interacting with the sheath shaft and result in the strut damage at the valve inflow side.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• 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: 24769936
• Report Number: 2015691-2026-13810
• Device Sequence Number: 21331922
• Product Code: NPT
• UDI-Device Identifier: 00690103215823
• UDI-Public: (01)00690103215823(17)281026(11)251027
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 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: 9755RSL29A
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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