MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9750CM26A
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Inflation Problem (1310); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist, during a transcatheter aortic valve replacement procedure by transfemoral approach, the 26mm commander delivery system, 26mm sapien 3 ultra resilia valve, and crimper were all prepped per ifu with no issues and handed off to the heart team.There was no resistance during delivery system insertion through the sheath.There was some tortuosity and slight resistance during valve alignment, but this was mild.Tortuosity was noted in the abdominal aorta, and the valve alignment required unlock/lock twice to remove built up tension during fine adjustment.Device was not torqued during the procedure.As the valve/system was advanced, there was the appearance of the valve frame over the pusher, but it cannot be determined if this was an optical illusion.The valve frame was positioned slightly back on the delivery system before valve deployment.The valve/system was advanced across the native anatomy, pusher was pulled back without issue, and the valve/system was ready for deployment.During valve deployment, unusual deployment was noted where the left ventricular outflow tract/distal end of balloon was not inflating as expected.The proximal/pusher end of balloon inflated as expected.The outflow of the valve expanded well; inflow was last to expand and there was some resistance.Primary position stated they had extra forward force as balloon was inflating over the visual concern of valve embolization.The frame did expand on both inflow and outflow but there was unequal inflation of the balloon.The valve was placed at 100/0 as intended to reduce risk of pacemaker implant.Ratio of contrast to saline in the inflation medium was 85ns, 15contrast.There was no fluid loss, withdrawal difficulty, or device damage noted.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24706736
• Report Number: 2015691-2026-13574
• Device Sequence Number: 18757830
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)271021(10)67117913
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/29/2026

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: 9750CM26A
• Device Catalogue Number: N/A
• Device Lot Number: 67117913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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