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	03/03/2026
Type of Reportable Event	Malfunction
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 using a 29 mm sapien 3 ultra resilia valve, it was noted that inflation of the 29 mm commander delivery system balloon required an extended period of time, which resulted in a prolonged pacing run.The inflation/deflation time was more than 20 seconds.The valve was able to be fully deployed in the intended location.There was no slow inflation/deflation time or any other abnormalities noted during device preparation.The device was not torqued during the procedure.There was no asymmetrical inflation noted.There was no resistance encountered during advancement of the delivery system with valve through the 16fr esheath+.There was no damage observed on the delivery system.There was also no damage observed on the esheath+.No fluid loss was noticed.There was no difficulty withdrawing the delivery system and esheath+.The patient was stable.There was no patient injury.Imagery was received for evaluation.Per review of the patient anatomy imagery, there was severe ovality observed in the annulus and left ventricular outflow tract (lvot).The ovality ratio of the annulus was 1.32 and the ovality ratio of the lvot was 1.36.There was calcification within the landing zone.There was tortuosity in the access vasculature.The aortic root angle was 44 degrees.Per review of the procedural fluoroscopy, the transcatheter heart valve (thv) was positioned between the valve alignment markers prior to deployment.The provided procedural fluoroscopy does not show the entire deployment cycle (total inflation and deflation time), but it shows difficulty during balloon inflation for at least fifteen (15) seconds, with the thv only partially expanded.The device was returned for evaluation.An inflation/deflation test was performed on the returned device, and the inflation/deflation time was found to meet specification.The balloon was fully inflated and deflated without issue.No other abnormalities were observed.

• 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: 24689939
• Report Number: 2015691-2026-13512
• Device Sequence Number: 15866372
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)271023(10)67140502
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/28/2026

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: 67140502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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