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

Model Number	9750CM20A
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist, during a transcatheter aortic valve replacement procedure by transfemoral approach, due to patient anatomy, the commander delivery system would not pass the aortic bifurcation.The delivery system was outside of the sheath.The team decided to remove the system.The valve came off the delivery system and was in the left iliac artery.The valve was inflated, and a covered stent was implanted across the valve to secure it in the left iliac artery.The patient was discharged in stable condition.
Additional Manufacturer Narrative
Updated section h6- type of investigation, findings, and conclusions.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The device was not returned for evaluation as it was discarded.The provided 3mensio imagery was reviewed, and the following was observed: in the comments section: "tf access does not meet minimum diameters.Carotid access appears consistent on the rt." tortuosity, calcification, and undersized vessel diameters (<5mm) were present in the left access vessel, near the aortic bifurcation and iliac.The 14f esheath+ is indicated for use with vessel diameters greater than or equal to 5.5mm.The complaints about the inability to track system through anatomy and valve dislodged off balloon during withdrawal through sheath are unable to be confirmed as no device or relevant imagery was provided for evaluation.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of the dhr did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.Per review of the 3mensio that was provided, tortuosity, calcification, and undersized vessel diameters (<5mm) were observed within the left access vessel, near the aortic bifurcation and the iliac.The 14f esheath+ is indicated for use with vessel diameters greater than or equal to 5.5mm.Per the training manual, "push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification." in this case, it was reported that the commander delivery system would not pass the aortic bifurcation, and the delivery system was outside of the sheath, suggesting that the sheath was not fully inserted past the aortic bifurcation.Additionally, 3mensio revealed calcified, tortuous, and under-sized access vasculature.Edwards training manuals caution "the thv should not be advanced through the sheath if the sheath tip is not past the aortic bifurcation".Patient factors (i.E.Calcification, tortuosity, small vessel size) may cause constrained sections of the anatomy that interfere with passage of the sheath and/or delivery system with thv and cause difficulty during tracking.As such, available information suggests that patient factors (undersized vessel, calcification, tortuosity) and/or procedural factors (sheath not advanced past aortic bifurcation) may have contributed to the inability to track the system through anatomy.Patient factors (tortuosity, calcification, undersized vessels), as observed in patient 3mensio, can lead to noncoaxial withdrawal angle, causing the crimped valve to be caught on the sheath tip during retrieval and lead to resistance during withdrawal.Additional device manipulation to overcome the withdrawal difficulties can dislodge the valve from the balloon, as reported.As such, available information suggests that patient factors (undersized vessel, calcification, tortuosity) and/or procedural factors (non-coaxial withdrawal, device manipulation) may have contributed to the valve dislodged off balloon during withdrawal through sheath.However, a definitive root cause is unable to be determined at this time.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: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 22908892
• Report Number: 2015691-2025-07066
• Device Sequence Number: 7932968
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)260320(10)65672957
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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 Expiration Date: 03/20/2026
• Device Model Number: 9750CM20A
• Device Catalogue Number: N/A
• Device Lot Number: 65672957
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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 Sex: Female