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

Model Number	9750CM23A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a field clinical specialist, during a transfemoral transcatheter aortic valve replacement procedure using a 23mm sapien 3 ultra resilia valve, the sheath was inserted without resistance and then the delivery system was inserted and the delivery system catheter cracked releasing flush from the crack.The resistance was attributed to angulation of the sheath.It was advised by the field clinical specialist that the sheath be pulled back slightly to reduce the severe angulation contributing to the resistance.After the crack of the ds, it was advised by the rep to remove the entire system (sheath, ds, valve) as one unit as to prevent stripping of the valve.The physician declined to exchange or remove the sheath at that time and requested a new delivery system and valve.A second delivery system, prepared per instructions for use with a new valve, was inserted into the existing esheath, at which point resistance was again encountered.Fluoroscopic imaging of the sheath demonstrated that two valves were visible within the sheath.At that point, the sheath, delivery system, and valves were removed together as a single unit, as initially recommended.A new sheath was introduced and internally dilated up to 18 french.A new delivery system and valve were subsequently inserted, and the valve was successfully deployed.The patient remained stable throughout the procedure.No patient injury was reported.
Additional Manufacturer Narrative
The investigation is ongoing.

• Brand Name: COMMANDER DELIVERY SYSTEM
• 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: 25128579
• Report Number: 2015691-2026-15040
• Device Sequence Number: 10694465
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)271103(10)67182112
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/18/2026

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: 9750CM23A
• 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: 06/11/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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: 87 YR
• Patient Sex: Female