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

Model Number	9750CM23A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 23 mm sapien 3 ultra (s3u) valve, wire position in the left ventricle (lv) was lost while the delivery system with valve was crossing the native aortic valve.The loss of wire position was due to the wire being inadvertently pulled out of the lv.There was no patient injury.There was difficulty withdrawing the delivery system with valve from the patient due to severe iliac disease.Valve alignment was performed and the valve was subsequently deployed in the descending aorta.A second 23 mm s3u valve was prepped and deployed successfully in the aortic valve.There was no damage noted to any edwards devices.

• 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: 25311266
• Report Number: 2015691-2026-15582
• Device Sequence Number: 16080133
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)271202(10)67271553
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9750CM23A
• Device Lot Number: 67271553
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female