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

Model Number	9750CM26A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be completed upon completion.This is one of two manufacturer reports being submitted for this case.
Event or Problem Description
Edwards received notification from a field clinical specialist that a patient underwent off label right transfemoral tmvr with a 26mm s3ur, 26mm commander, and non-edwards sheath.As reported, the patient had severe degree of mitral annular calcification.The first inflation deployed the valve at approximately a 90/10 position.During inflation, the valve began to migrate atrially (80/20), and paravalvular leak (pvl) was noted.To prevent further migration, an additional 2cc was added to the commander delivery system (ds) for a second deployment attempt.However, the additional 2 cc could not be transferred into the balloon.A third attempt was made to post dilate, but again the balloon could not be fully filled with contrast, and complete inflation could not be achieved.At this point, a second commander ds was prepared with a total of 28 cc of 15% contrast using the same atrion syringe and contrast mixture as the initial commander ds.Due to the persistent pvl, the team decided to implant a second 26 mm valve.The second valve was deployed successfully, resulting in resolution of the issue.The patient's final outcome was noted as stable condition.Per the field clinical specialist, the difficulty transferring the additional 2cc into the balloon, the balloon had already been inflated twice during the procedure.It was not certain of the exact reason why the additional volume could not be delivered, but the physician mentioned that it was extremely difficult to inflate at that point.

• 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: 25249898
• Report Number: 2015691-2026-15437
• Device Sequence Number: 10500610
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)280122(10)67421562
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9750CM26A
• Device Catalogue Number: N/A
• Device Lot Number: 67421562
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO
• Patient Sex: Female