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

Model Number	9750CM29A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, a 29mm commander delivery system was used to deploy a 29mm sapien 3 ultra resilia valve in the native aortic annulus.It was noted that the delivery system had been torqued during the procedure due to a horizontal heart and a left subclavian approach.During valve deployment, the delivery system balloon would not completely inflate.Approximate inflation time was 10 seconds, and the deflation time was an additional 10 seconds.Asymmetrical inflation was not observed.The valve was deployed in the intended location but was left under expanded.There was no issue withdrawing the delivery system through the 16fr esheath+.A second delivery system was opened and inserted through the same esheath+.The second delivery system was used to fully expand the valve, which was completed without incident.There was no injury to the patient, and the patient was discharged.It was noted that the 16fr esheath tip was damaged, which was thought to have occurred when the delivery system was torqued, and was a result of delivery system manipulation.The perceived root cause of the delivery system's inability to completely inflate is unknown.There was no damage noted to the delivery system, stop cock, or tubing.Image of the sheath post procedure was provided, and a distal tip split was observed.Per the reporter, there was no note of slow inflation or deflation times during device preparation.There was no resistance advancing the sheath, and there was no noted unusual resistance advancing the delivery system through the sheath.There was no resistance removing the sheath and no difficulties removing the delivery system.
Additional Manufacturer Narrative
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: 24912953
• Report Number: 2015691-2026-14455
• Device Sequence Number: 18623987
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)271202(10)67271558
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/16/2026

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: 9750CM29A
• Device Lot Number: 67271558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 69 YR
• Patient Sex: Male