MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DS WITH SAPIEN 3; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number	9750CM29A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist (fcs), a patient underwent a transseptal transcatheter mitral valve replacement (tmvr) procedure with a 29mm sapien 3 ultra resilia valve inside a pre-existing surgical valve in the mitral position.During the procedure, the implanting physician encountered difficulty advancing the valve across the surgical mitral valve.To improve wire trajectory and facilitate device tracking, the tip of the wire was snared from the aorta.This maneuver allowed the valve and delivery system to be advanced across the surgical valve.However, once positioned, the delivery system balloon failed to inflate when valve deployment was attempted, and blood was observed entering the atrion when negative pressure was pulled back.The physician then attempted to retract the valve and delivery system into the 16fr esheath, but the valve would not enter the tip of the sheath.As a result, the physician opted to cut the proximal end of the delivery system using wire cutters, and the 16fr esheath was removed over the remaining portion of the flex catheter shaft.A 26fr non-edwards sheath was then inserted over the flex catheter shaft and advanced into the femoral vein.The valve and remaining commander delivery system were subsequently removed from the body, and the vein was closed using a mattress suture.The physician ultimately elected to defer further intervention and bring the patient back for a repeat tmvr attempt at a later date.The patient remained stable throughout the procedure, and no injury to the patient occurred.

• Brand Name: COMMANDER DS WITH SAPIEN 3
• Common Device Name: PROSTHESIS, MITRAL VALVE, 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: 25257700
• Report Number: 2015691-2026-15462
• Device Sequence Number: 14826633
• Product Code: NPU
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)271013(10)67117916
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/09/2026

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: 67117916
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 90 KG