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

Model Number 9600LDS29A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the field clinical specialist, during a transfemoral tavr procedure with a 29 mm sapien 3 valve, there was difficulty delivering the valve and exiting out of the sheath due to tortuous anatomy.Valve alignment was challenging and unable to be completed.The valve was removed out of the body and exchanged for a stiffer wire.A new valve was used to successfully complete the procedure.No patient complications were reported.Per feedback from the fcs, there was a hole in the balloon from all the pushing trying to get the valve in the body and also from the physician doing valve alignment in tortuous segment.

Manufacturer Narrative

A supplemental report is being submitted for the completed engineering evaluation.Sections b.2, b.4, g.3, g.6 and h.2 have been updated.Corrections have been made to h.6: type of investigation, investigation findings, and investigation conclusion.An addition was added to h.6: component code.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 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.An existing engineering summary written by edwards lifesciences establishes, that for the commander delivery system, difficulty navigating the catheter through the anatomy is an identified hazardous situation associated with the transcatheter valve replacement procedure.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 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 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.Additionally, available information suggests that patient factors (tortuosity) and/or procedural factors (valve alignment in the non-straight section, built up tension, high valve alignment forces) may have contributed to the valve alignment event as the event description stated the patient had a ''tortuous anatomy'' and the valve alignment ''was not attempted in a straight section of the anatomy.'' if valve alignment was performed in a tortuous vasculature (non-straight section), this could have caused the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and ''dive'' into the flex tip.If the transcatheter heart valve (thv) was unseated from the flex tip during alignment, it could have resulted in higher-than-normal alignment forces creating high tension in the system, which could have consequentially led to the reported valve alignment difficulties.The complaint for balloon leak was unable to be confirmed as no product was returned and no applicable imagery was provided.Available information suggests that procedural factors (high valve alignment forces) may have contributed to the event as the event description stated, ''there was a hole in the balloon from all the pushing trying to get the valve in the body and also from the physician doing valve alignment in tortuous segment.'' high forces on the system during valve alignment may result in interaction between the crimped valve and delivery system balloon damaging it prior to thv deployment.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: 18611124
• MDR Text Key: 334384721
• Report Number: 2015691-2024-00674
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 140031
• 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: 03/15/2024

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
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/15/2024
• 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 Sex: Male