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

Model Number	9750CM26A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was completed.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 complaint inflation difficulty was confirmed based on review of provided imagery.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.However, reviews of the dhr and lot history 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.As reported, ''the inflation deployment was asymmetrical.'' per review of provided procedural imagery, the valve was adequately positioned between the valve alignment markers prior to deployment.During deployment, inflation of the balloon was constrained at the distal end, with the distal constraint eventually overcome and full inflation achieved.Additionally, just prior to the distal constraint of the balloon being overcome, a shadow is visible near the valve inflow side, resembling a separated sheath tip.While there was no evidence indicating that a manufacturing non-conformance may have contributed to the complaint, the investigation shows that the reported event may be related to device interactions, caused by a potential circumferential tear at the sheath's distal tip.Such a tear could lodge against the distal end of the valve or balloon and impede uniform deployment.No labeling/ifu deficiencies were identified.However, the investigation suggests that the reported event is likely related to device interactions, resulting from a torn and separated sheath distal tip.A product risk assessment (pra) was previously initiated to investigate the constrained inflation and its associated risks.A capa was initiated to further investigate esheath+ distal tip tears.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.This is one of two manufacturer reports being submitted for this case.
Event or Problem Description
Edwards received notification from a field clinical specialist that a patient underwent a transfemoral tavr procedure with a 26mm sapien 3 ultra resilia valve.As reported, the inflation deployment was asymmetrical.The team believed that lvot calcium and annular calcium contributed by causing more push force on inflow of balloon.The valve was able to be fully deployed.The approximate inflation/deflation time was unknown.No fluid loss was noticed.The ratio of contrast to saline in the inflation medium was 15 ml of contrast (15:85).The valve deployed in the intended location.There was no slow inflation/deflation time or any other abnormalities noted during prep.There was no damage seen on the device before or after the removal.There was no withdrawal difficulties with the delivery system and/or sheath.There was no patient injury.The patient's final outcome was noted as discharged.The provided imagery was reviewed, and the following was observed: inflation of balloon was constrained at the distal end, with distal constraint eventually overcome and full inflation achieved valve appeared adequately between markers prior to deployment.Just prior to the distal constraint of the balloon being overcome, a shadow was visible near the valve inflow that resembles a separated sheath tip.

• 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: 24781822
• Report Number: 2015691-2026-13837
• Device Sequence Number: 9987973
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)270731(10)66876295
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9750CM26A
• Device Catalogue Number: N/A
• Device Lot Number: 66876295
• 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: 03/11/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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
• Patient Sex: Male