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

Model Number	9750CM29A
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Embolism (4439); Unspecified Vascular Problem (4441)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during implant of a 29 mm sapien 3 ultra resilia valve in the mitral position via right transfemoral vein within a non-ew surgical valve, a clot was observed and team decided to bail on procedure, treat the clot and come back for another attempt.There were no issues attempting to remove the delivery system and sheath out of the patient, however removing the 29mm s3ur posed a different problem and damage to the femoral vein occurred which led to a surgical repair.An end-to-end primary surgical closure was performed.The patient was stable and will be re-evaluated at a later date for their tmviv procedure.Additional information noted that "the issue in these situations is that the valve cannot be re-introduced into the sheath.Upon removing the delivery system, the valve hits the distal end of the sheath and slides off the delivery system.It's essentially floating on the wire.We were able to retract it to the access point near the groin.A hemostat was used to retrieve the valve.That's when the injury to the vessel occurred.".
Additional Manufacturer Narrative
A supplemental mdr is being submitted for completion of the investigation.The following sections have been added: b4, g3, g6, h2, h6, h11.The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.No imagery was provided.Through extensive complaint investigations, events reporting difficulty/inability withdrawing catheter with crimped valve through patient vasculature or through the sheath have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to patient factors, non-coaxial withdrawal, altered crimp profile, damaged sheath, not centering the thv on the flex tip, and/or withdrawing the thv through the sheath hub.The complaint for difficulty or inability to withdraw system with valve through sheath and thv dislodged off balloon was empirically confirmed as no procedural imagery or event unit was returned.Available information suggests patient factors and non-coaxial withdrawal likely contributed to the event as the customer reported that the patient had 'severe calcification and stenosis' and 'that the valve cannot be re-introduced into the sheath.Upon removing the delivery system, the valve hits the distal end of the sheath and slides off the delivery system'.Patient factors (i.E.Calcification, tortuosity, or small vessel size) may cause constrained sections of the anatomy that interfere with passage of the delivery system and causes difficulty during withdrawal.Additionally, proper withdrawal technique is important, as non-coaxial withdrawal of the delivery system with crimped thv may cause the system or thv to interact with the sheath, resulting in difficulty withdrawing and thv dislodging off balloon.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• 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: 24469485
• Report Number: 2015691-2026-11597
• Device Sequence Number: 13157153
• Product Code: NPU
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)271013(10)67117916
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 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: 02/09/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male