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

Model Number	9750CM26A
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist (fcs), approximately 6 years, 3 months, 1 day post transfemoral tavr procedure with a 29mm sapien 3 valve, the valve presented stenosis.The patient underwent a successful valve in valve procedure with a 26mm sapien 3 ultra resilia valve.Per additional information received, the patient presented shortness of breath with a mean gradient of 56.5mmhg and a peak gradient of 97.9mmhg.The valve area/index of the failed valve was 0.54 cm2.The leaflets were calcified with limited mobility.The patient was discharged home.During the valve in valve procedure, the balloon on the 26mm commander delivery system burst circumferentially during valve deployment at full inflation with +1cc.During withdrawal, there were difficulties.However, the balloon was able to be pulled back into the 14fr esheath+ and removed.A new 14fr esheath+ was inserted.The patient was stable and the esheath+ was removed with successful groin closure.The patient was sent to recovery.There was no injury to the patient.Per report, bav was performed pre-implant.Valve alignment was performed in a straight section.Per images received, the distal tip of the balloon was separated.
Additional Manufacturer Narrative
Investigation is still ongoing.

• 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 (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: 25216931
• Report Number: 2015691-2026-15332
• Device Sequence Number: 21282501
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)271210(10)67296535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 9750CM26A
• Device Lot Number: 67296535
• 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: 04/23/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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 Sex: Unknown