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

Model Number	9750CM29A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, during a right-side transfemoral access transcatheter aortic valve replacement procedure with a 16fr esheath+, commander delivery system, and a 29mm sapien 3 ultra resilia valve, the commander balloon ruptured during inflation.The reporter stated that the patient had a calcified sinotubular junction (stj).Inflation of the commander balloon was described as "slow and deliberate", and no additional volume was added to the balloon prior to inflation.With approximately 1 ml of inflation volume remaining, the balloon ruptured.The team attempted to remove the delivery system from the sheath, but was unable to do so, as withdrawal difficulty occurred when reaching the distal portion of the sheath in the aorta.The way the balloon ruptured left a large amount of material towards the nosecone.This resulted in removal of the wire, sheath, and balloon together as a single unit.A radial tear to the delivery system balloon was noted.Moderate pulsatile blood loss occurred, and perclose sutures were tightened.Additional manual pressure was held for 15 minutes.After the pressure hold, an aortogram verified that flow beyond the access site was not compromised.Manual pressure was discontinued with no further blood loss.The patient did not require a blood transfusion.The valve was fully deployed, and the patient was reported to be in stable condition post-procedure.The reporter identified calcium in the stj as the perceived root cause of the balloon rupture.It was thought that the moderate pulsatile blood loss was a result of the balloon material pulling through the arteriotomy.
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: 25325753
• Report Number: 2015691-2026-15623
• Device Sequence Number: 5368915
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)271210(10)67296538
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/25/2026

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: 67296538
• 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: 06/22/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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: 65 YR
• Patient Sex: Male