MAUDE Adverse Event Report: Edwards Lifesciences Edwards Commander Delivery System; Aortic valve, prosthesis, percutaneously delivered

Model Number	9750CM29A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by implant patient registry and the field clinical specialist (fcs), during implant of a 29 mm sapien 3 ultra resilia (s3ur) valve into a surgical valve in the mitral position, the commander delivery system was unable to advance past the patient's septum.Upon retrieving it a third time, the 29mm s3ur hit against the edge of the esheath+ and the valve embolized.The 29mm s3ur was retrieved but the decision was made to switch to a 26mm s3ur with added volume in order to get past the septum.It did get past it with some difficulty, and the valve was implanted successfully.The patient was stable following the procedure.The perceived root cause of the crossing difficulty was anatomical challenges- thick septum and bad angles.No devices were damaged in the case.
Additional Manufacturer Narrative
The investigation is 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 ; +1(949)250-6385
• MDR Report Key: 50817853
• Report Number: 2015691-2026-18671
• Device Sequence Number: 21376664
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)280330
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 9750CM29A
• Device Lot Number: 67607851
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2026
• 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: 72 YR
• Patient Sex: Male