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

Model Number 9750CM20A

Device Problem Failure to Advance (2524)

Patient Problem Pericardial Effusion (3271)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : device will not be returned.

Event Description

During a tavr procedure using a 20mm sapien 3 ultra valve via subclavian approach, the delivery system with valve failed to track or cross the annulus due to calcium and tortuosity.The patient developed an effusion, and a window procedure was performed to relieve the effusion and the case was aborted.The perceived root cause of the effusion was because the implanter wanted to use a conduit in place of direct subclavian access.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, 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.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 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.Edwards has provided guidelines and instructions to physicians on visualization, assessment, and preservation of the vasculature, adequate preparation of the vasculature, the optional use of pre-dilitation of the target valve, and proper use of flexion while performing navigation through the anatomy in the ifu and training materials/refresher training.In addition, edwards's physician training program includes case observation/review, proctor qualification, and refresher training.A 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 interfere with the passage of the delivery system and can cause 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 patient 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 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, tortuosity) 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.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: COMMANDER DELIVERY SYSTEM
• Type of Device: 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: 18346585
• MDR Text Key: 330783978
• Report Number: 2015691-2023-18475
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM20A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2024
• 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): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female