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

Model Number	9750CM20A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a right-side transfemoral tavr (transcatheter aortic valve replacement) procedure with a 20mm sapien 3 ultra resilia (s3ur) valve in the native aortic position, the operating team over-shot the s3ur valve during valve alignment.It was noted that the s3ur valve was almost completely off the 20mm commander delivery system (ds).The operating team decided to cross the native valve in an attempt for the s3ur valve to slide back onto the balloon; however, this resulted in the loss of guidewire access.In response, the stiff deployment wire was removed, and this caused the ds to jump forward, leading to injury/pericardial effusion.After the patient was stabilized, the first system was removed and a new system was used to implant a 20mm s3ur valve.The patient was then taken to surgery to locate the bleed and the lv injury was surgically repaired.Per report, the patient has since been discharged home.According to the reporting physician, he does not believe the left ventricle (lv) injury is related to the valve deployment or positioning, but rather, related to the safari guidewire.It was noted that the patient's lv was friable and the safari loop acted as a slicer.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: component code, investigation findings, investigation conclusions and h11 have been updated.Additions to section h6: type of investigation.The event(s) reported is/are anticipated in the risk management documentation for transcatheter heart valve procedures.Additional assessment of the failure mode(s) is not required at this time.The devices were returned for evaluation and the following pre-decontamination observations were made: 20mm commander delivery system (ds) returned with loader cap inserted over flex shaft, 14fr esheath+ partially inserted dover the flex shaft, valve is crimped over the inflation balloon within the sheath, handle has 50 percent fine adjust (locked position and warning marker), and no damages observed on the sheath (opened as designed).Functional testing was then performed and the following were observed: delivery system advanced out of the sheath with the crimped valve positioned on the distal end of the inflation balloon, balloon partially inflated to remove valve from ds, and able to perform fine adjust and gross alignment without difficulties.The instructions for use (ifu), training manuals and current risk mitigations have been reviewed.No inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.In this case, while the complaint of valve alignment inability was confirmed based on evaluation of the returned device, the complaint of inability to cross the native annulus was unable to be confirmed as no procedural imagery was provided.Available information suggests that use error (over-rotation of fine adjustment wheel, guidewire mismanagement) may have contributed to the reported events.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 (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: 23752690
• Report Number: 2015691-2025-09857
• Device Sequence Number: 5892275
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)270623(10)66763332
• 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
• 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): 02/20/2026

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: 9750CM20A
• Device Lot Number: 66763332
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: Female