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

Model Number	9600LDS29A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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 left transfemoral approach, the valve could not be fully deployed because the balloon failed to receive nominal inflation volume.Valve and delivery system were prepped normally (nominal volume).During initial valve deployment, valve expanded approximately 60-70% when the implanter noted he was at full volume on the atrion.The balloon was deflated.Valve was anchored securely in annulus by existing calcification.Atrion was reloaded with nominal volume for a 29mm valve (33ml) and a second inflation/post-dilation was attempted.At this time, it was noted that contrast was exiting the delivery system near the connection between the fine adjustment wheel and the balloon catheter.This delivery system was removed.A second delivery system was prepped with the same atrion to nominal volume (33ml) and successful inflation/expansion of the valve was achieved.There were no abnormalities noted during prep, no resistance during delivery system insertion through the sheath, slow inflation/deflation time, asymmetrical inflation, withdrawal difficulties with the delivery system and/or sheath, nor any damage seen on the devices before or after the removal.Ratio of contrast to saline in the inflation medium was 15:85.

• 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: 24457850
• Report Number: 2015691-2026-11568
• Device Sequence Number: 10148708
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)271007(10)67097592
• 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): 06/12/2026

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: 9600LDS29A
• Device Catalogue Number: N/A
• Device Lot Number: 67097592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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