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

Model Number	9600LDS20A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, regarding a 20mm sapien 3 valve in the mitral position.When the 20mm sapien 3 valve and 20mm commander delivery system were inserted into the gore dryseal, the implanting physician said he felt a crack in the commander delivery system catheter.Upon removal of the first delivery system and valve, it was noticed that all the flex was not taken back out of the delivery system.There was no patient injury.A second 20mm sapien 3 valve and 20mm commander delivery system were used successfully.
Additional Manufacturer Narrative
Investigation is underway.
Additional Manufacturer Narrative
A supplemental mdr is being submitted to correct the reportability of the event previously reported.Per engineering evaluation of the returned commander delivery system, there were no cracks on the device identified, and x-ray confirmed no abnormalities.Engineering was able to perform functional testing with no issues noted.At the time of this report, the information available does not suggest the commander delivery system malfunctioned, or that the use or miss-use of the device caused or contributed to an injury.There was no deficiencies related to the identity, quality, durability, reliability, safety, labeling effectiveness, or performance of this commander delivery system, therefore the event is no longer considered fda reportable.

• 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 (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: 23347669
• Report Number: 2015691-2025-08686
• Device Sequence Number: 20785571
• Product Code: NPT
• UDI-Device Identifier: 00690103193930
• UDI-Public: (01)00690103193930(17)260716(10)65915985
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/02/2025

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 Expiration Date: 07/16/2026
• Device Model Number: 9600LDS20A
• Device Lot Number: 65915985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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
• Patient Age: 8 YR
• Patient Sex: Female