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

Model Number	9750CM23A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
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 commander delivery system balloon ruptured during deployment on sinotubular junction calcium.The 23mm sapien 3 ultra valve was fully deployed with no leak.The balloon was removed without issue.The patient was doing well.

• 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: 24757681
• Report Number: 2015691-2026-13762
• Device Sequence Number: 18335982
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)270618(10)66695102
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/05/2026

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
• Device Catalogue Number: N/A
• Device Lot Number: 66695102
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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: Female