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

Model Number	9600LDS29A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist (fcs), it was a case of a 29 mm sapien 3 valve in the aortic position via transfemoral approach.During device withdrawal after valve deployment, the delivery system balloon was stuck at the access site, as it was not fully retracted into the sheath.A femoral cutdown was performed, and the vessel was repaired with a patch.Subsequently, the patient developed a cold leg, and an embolectomy was performed.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Balloon catheter and guidewire lumen/balloon subassembly returned detached likely from surgical cutdown performed in the field.16fr esheath + returned with liner fully expanded as designed.Imagery was provided from the site and revealed the following: tortuosity is present in the patient's access vessels.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.Through extensive complaint investigations, events reporting difficulty/inability withdrawing catheter 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 balloon profile, damaged sheath, and/or damaged guidewire.The complaint was confirmed based on the returned device condition.Available information suggests patient factors likely contributed to the event as imagery review of provided 3mensio revealed tortuosity present in patient's access vessels.Patient factors (i.E.Calcification, tortuosity, scar tissue, or small vessel size) may cause constrained sections of the anatomy that interferes with passage of the delivery system and causes difficulty during withdrawal.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: 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: 23084783
• Report Number: 2015691-2025-07675
• Device Sequence Number: 9702289
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)270423(10)66548859
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/25/2025

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 Model Number: 9600LDS29A
• Device Lot Number: 66548859
• Was Device Available for Evaluation?: Yes
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• 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: 73 YR
• Patient Sex: Male