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

Model Number	9600LDS29A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, a 29mm sapien 3 valve was to be implanted in the aortic position via transfemoral approach.The valve and 29mm commander delivery system were advanced without issue.The valve was aligned in a straight segment of the descending aorta per ifu without difficulty.The valve and delivery system were positioned in the annulus and pacing was started.When the operator tried to deploy the valve, the balloon did not inflate.When they pulled negative, blood was observed in the inflation device.The valve, delivery system, and sheath were removed without difficulty and with no patient complication.A new 29mm sapien 3 valve and new commander delivery system were prepared and deployed successfully.The patient is stable.Upon removal of the delivery system, a balloon tear with ic bond break was observed.Leaking was seen out of the proximal portion of the balloon.
Additional Manufacturer Narrative
Investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The following sections of this report have been updated: additional codes added to h6 type of investigation, corrected h6 investigation findings, and corrected h6 investigation conclusions.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.Additional assessment of the failure mode is not required at this time.The device was returned for evaluation.A visual evaluation was performed, and the following was observed: balloon torn was observed at inflation/crimp (ic) bond area.Balloon proximal wings were flared.Dimensional testing was performed by measuring the crimp balloon double wall thickness along the edges of the damaged area, and all measurements met the specification.Due to the nature of the event, no applicable functional testing was performed.The instructions for use (ifu), 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.Pre-procedural imagery was provided, and the following was observed: tortuosity was present in the access vessels and aorta.The torn delivery system balloon was confirmed based on the product evaluation.Based on the evaluation, the crimp balloon wall thickness met the specifications.In addition, no abnormalities on the device were reported during device unpacking, preparation or insertion.Therefore, an edwards manufacturing deficiency was unable to be confirmed through the returned device evaluation.Imagery revealed the presence of tortuosity in patient access vessels and aorta.Although no valve alignment difficulties were reported, patient tortuosity can increase alignment forces, which may lead to crimp balloon tearing prior to the thv deployment.As such, available information suggests that patient and/or procedural factors (increased alignment forces due to vessel tortuosity) may have contributed to the reported event.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: 22107657
• Report Number: 2015691-2025-04253
• Device Sequence Number: 8149854
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)261015(10)66090117
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/22/2025

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: 9600LDS29A
• Device Lot Number: 66090117
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male