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

Model Number	9600LDS20A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the field clinical specialist (fcs), approximately 3 years, 2 months, and 23 days post-implant of a 20 mm sapien 3 (s3) valve in the mitral position, the 20 mm sapien 3 valve was noted to be stenotic.The mean inflow gradients were between 12-15mmg.Due to the patient's history, this was found on a routine exam which the echo revealed bi-atrial enlargement also.During the valve in valve case, the implanting cardiologist (ic) and team had difficulty positioning the new 20mm s3 inside of the existing 20mm s3.It appeared that the ic could not get it coaxial enough to fully cross and position appropriately and when pushing on the commander delivery system, at one point, the valve appeared to 'jump' forward into the left ventricle (lv).The working wire (safari extra small) may have jumped forward also.The team pulled the new s3 valve back, nearly to an acceptable position to deploy, but then it moved too atrial.They continued to struggle to cross the existing valves (the previous 20mm s3 was already inside of a 23mm epic supra that was placed in 2018).Somewhere near this point in time we noticed the patient's blood pressure began to decline.The heart rhythm changed to a rapid a flutter vs supraventricular tachycardia (svt).They attempted a couple more maneuvers to try and get new s3 across the failed one but were unsuccessful.Due to the patient's rapid decline hemodynamically, they removed the new 20mm s3, commander and 14f esheath+ in order to interrogate the patient's collapse in condition.A new 16f esheath was inserted (was readily available in the room).They performed a synchronized cardioversion and then noticed a widening qrs so they started looking for fluid around heart.After several minutes they were able to perform pericardiocentesis, and bright red blood continued to aspirate.The surgeon was in the room by now, along with many others.They injected a small amount of contrast dye into aspiration cannula and there may have been a hole or tear in the lv apex.The team discussed and the patient was stabilized and transferred immediately to the operating room for intervention.The attempted new 20mm s3 was not implanted in the patient.
Additional Manufacturer Narrative
This is two of two manufacturer reports being submitted for this case.The investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to the completion of the investigation.The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary: the ifu, current risk mitigations including design and manufacturing controls, and training manuals have been reviewed, and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Through extensive complaint investigations, difficulty or inability in tracking the delivery system to the landing zone, including traversing the aortic arch and crossing the native annulus/bioprosthesis has not been associated with device malfunctions or manufacturing non-conformances.Rather, the root cause for these events have historically been due to patient factors, poor guidewire management, damaged guidewire, and/or excessive manipulation of the flex wheel.The complaint for difficulty or inability to cross native annulus and/or bioprosthesis' was unable to be confirmed as procedural imagery was not provided for evaluation.Available information suggests that patient factors (stenosis of pre-existing thv) likely contributed to the event, as it was reported that the pre-existing thv was stenotic and appeared "thickened with a narrowed inflow jet.' patient factors (i.E.Stenotic pre-existing thv) may cause constrained sections of the anatomy that interfere with passage of the delivery system and cause difficulty during crossing.

• 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: 22022497
• Report Number: 2015691-2025-03835
• Device Sequence Number: 8769930
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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 Expiration Date: 07/16/2026
• Device Model Number: 9600LDS20A
• Device Lot Number: 65915985
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Sex: Female