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

Model Number 9600LDS26

Device Problem Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.H3 other text : device not returned for evaluation.

Event Description

As reported by the field clinical specialist, during a right transfemoral tavr procedure, the team was unable to deliver the 26 mm sapien 3 ultra valve passed the abdominal aorta due to calcium in the aorta.The valve was safely delivered in the external iliac because the physician was unable to get the valve in the sheath and safely remove it.There was no vascular injury, and the devices were not damaged upon removal.There were no issues withdrawing the delivery system.The case was aborted after the devices were removed.No additional patient complications were reported.

Manufacturer Narrative

A supplemental report is being submitted for the completed engineering evaluation.Corrections have been made to h.6: type of investigation, investigation findings, and investigation conclusion.The event reported is 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.The device was not returned for evaluation.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 instructions for use (ifu), current risk mitigations include design and manufacturing controls, 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.Imagery provided from the site was evaluated and revealed tortuosity and calcification present within the patient's iliac arteries and abdominal aorta.Per edwards internal documents for the commander delivery system, difficulty navigating the catheter through the anatomy is an identified hazardous situation associated with the transcatheter valve replacement procedure.The commander delivery system is designed to be compatible with a standard 0.035'' guidewire to enhance trackability.The nose tip is designed to be atraumatic and provide better anatomical crossing, while providing a gradual dimensional increase.Articulation of the system is also instrumental in trackability to the target treatment zone.The ability to articulate allows the catheter to traverse the aortic arch over an 0.035'' guidewire with minimal interaction between the delivery system nosecone, crimped thv, patient vasculature and calcification that may be present.Flex/articulation is designed to occur in one direction with minimal deflection from the flex plane.The catheter deflection angle, and deflection plane are verified for effectiveness.The flexion of the commander delivery system is validated, as articulation of the system is also instrumental in navigation through the anatomy to the target treatment zone while minimizing vascular interaction, including traversing the aortic arch, as well as crossing the native or surgical bioprosthetic in the most achievable, non-biased form.System materials are specified through design requirements, while manufacturing and packaging procedures include 100% inspection for loose fragments.Review of prior closed similar complaints that were able to be confirmed indicates that patient and/or procedural factors can contribute to difficulty or inability in tracking the delivery system to the landing zone, including traversing the aortic arch and crossing the native annulus/bioprosthesis.Patient factors such as calcification, tortuosity, small vessel size, or pre-existing vascular stent may cause constrained sections of the anatomy that interferes with the passage of the delivery system and causes difficulty during tracking.Proper use of the guidewire is important as it serves to guide the delivery system during tracking and crossing of the anatomy.As such, poor guidewire positioning and/or loss of guidewire placement may cause the delivery system to interact with the patient's anatomy, leading to difficulty tracking/crossing.Additionally, navigating over a kinked guidewire or incorrectly sized guidewire may cause resistance between the guidewire and guidewire lumen, leading to difficulty tracking/crossing.Finally, excessive manipulation of the flex wheel may cause misalignment between components of the flex assembly within the delivery system handle, damaging the components and causing resistance or the inability to fully flex the delivery system, leading to difficulty crossing the aortic arch and/or native annulus/bioprosthesis.In this case, the complaint was unable to be confirmed.Investigation results suggest/indicate patient factors (calcification) may have caused or contributed to this complaint event.No edwards defect or manufacturing non-conformance that would have contributed to the reported event was identified.No ifu/training deficiencies were identified.Therefore, no further escalation is required.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
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18722593
• MDR Text Key: 335595909
• Report Number: 2015691-2024-01110
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male