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

Model Number COMMANDER DELIVERY SYSTEM

Device Problems Deflation Problem (1149); Positioning Failure (1158); Inflation Problem (1310); Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Event Description

Per field clinical specialist, the patient had severely torturous aorta, access was not great either as patient was heavily calcified so there was a lot of resistance with delivery system when trying to get the valve in place as it was not perfectly centered in balloon nd was about 2 to 3mm off center.They refine adjusted and it centered, then they crossed the native valve, started pacing, went to inflate and really had to inflate as it was difficult to inflate due to the tortuous aorta.They were finally able to complete the procedure, the position of valve was good, there was no leak.

Manufacturer Narrative

B5 updated.

Manufacturer Narrative

Type of investigation, investigation findings and conclusion codes, as well as h.10.No product was returned to edwards lifesciences for evaluation, therefore not visual inspection, functional testing or dimensional testing could be performed.However, complex imagery was provided and reviewed.The provided fluoro/cine imagery were reviewed by engineering.The provided images did not capture device tracking through the anatomy.The patient appeared to have a tortuous or horizontal aorta.The valve was not fully aligned within the markers with flex shaft compression and valve diving observed.Tension was released (no compression seen on flex shaft) after flex tip retraction to triple markers and valve remains off the distal valve alignment markers.Initial and final valve deployment.The fluoro did not capture the continuous balloon inflation.The valve appeared to be under expanded.The valve was successfully implanted in aortic annulus and contrast injection shows no leakage.Based on evaluation of returned imagery, the complaint fine adjust difficulty was confirmed based on evidence of compression introduced into the system due to tension created during valve alignment difficulty.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.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.The complaint for fine adjust was confirmed based on evaluation of the provided imagery.However, the complaints for complaints for difficult to track system through anatomy, inflation difficulty and/or incomplete inflation and balloon deflation difficulty were unable to be confirmed as neither the complaint device nor applicable procedural imagery was provided for evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.A review of the ifu and training manuals revealed no deficiencies.An existing technical summary has been documented for root cause analysis associated with difficulties that occur while aligning the thv onto the inflation balloon when using an edwards commander delivery system.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why tension build up in the system due to valve alignment difficulty can potentially lead to a series of secondary failures such as (thv movement on balloon, balloon torn, balloon or delivery system leakage, withdrawal difficulty, component separation, and/or thv dislodgement).As reported, ''patient had severely torturous aorta, access was not great either as patient was heavily calcified and there was a lot of resistance with delivery system when trying to get the 29mm valve in place; everything went through the sheath with no problem, when the valve was finally positioned it was not perfectly centered in balloon (about 2 to 3mm off center)''.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 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.During evaluation of returned imagery, it was observed that compression was present on the balloon catheter, likely due to tension created during valve alignment difficulty.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve alignment.It should be noted that these mitigations are still in place.In this case, review of available information suggests that patient factors (tortuosity) and/or procedural factors (valve alignment in the non-straight section) contributed to the valve alignment difficulty.Per additional information via medical records review, ''there were issues with trying to navigate the delivery system and valve across the native aortic annulus due to the aortic root being horizontal''.A tortuous anatomy can present difficult bend angles or constrained condition resulting in higher resistance for the devices to overcome.This can potentially lead and contribute to the reported difficulty felt when attempting to track the delivery system through the patient's anatomy.However, without applicable procedural imagery or return of the complaint device, a definitive root cause is unable to be determined.Available information suggests that patient factors (tortuosity) may have contributed to the complaint event.As reported, ''they crossed the native valve, started pacing, went to inflate and really had to inflate as it was difficult to inflate due to the tortuous aorta''.Per additional information via medical records review, ''there were issues with inflating the ds balloon, which was described as ''extraordinary difficult'' to inflate'' and ''the operator deflated the balloon which also took a lot of time''.As no abnormalities were observed during device preparation, it is likely that tortuosity of the patient's native anatomy resulted in the reported inflation/deflation difficulty.It is possible that tracking though tortuous patient anatomy resulted in over-flexing, causing twisting, torquing or compression of components involved in the fluid path and contributing to the reported resistance during inflation and deflation of the balloon.However, without applicable procedural imagery or return of the complaint device, a definitive root cause is unable to be determined.Available information suggests that patient factors (tortuosity) may have contributed to the complaint event.The ifu 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.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.No corrective or preventative actions are required.

Manufacturer Narrative

Correction to section g3 of initial mdr.The correct aware date of the new information was 08/08/2023, not 08/17/2023 as initially reported.Additional corrections: a3 changed from female to male.Investigation is ongoing.

Event Description

As reported, per the field clinical specialist patient had severely torturous aorta, access was ''not great either'' as patient was heavily calcified.It was noted there was a lot of resistance with 29mm commander delivery system (ds) when trying to get the 29mm sapien 3 valve in place.It was confirmed that there were issues with trying to navigate the delivery system and valve across the native aortic annulus due to the aortic root being horizontal.There was no difficulty when pushing the delivery system and valve through the esheath.When the valve was finally positioned it was not perfectly centered in balloon (about 2 to 3mm off center).It was also confirmed that the valve was not within the balloon markers when it was deployed despite attempts to bring the tip of the balloon completely back into the stent to line up with the markers, which the operator was unable to do.The decision was made to deploy the valve which was done under rapid pacing.However, there were issues with inflating the ds balloon, which was described as ''extraordinary difficult'' to inflate and it became clear that the distal portion of the valve was more inflated than the proximal potion.The operator deflated the balloon which also took a lot of time, and carefully moved the ds and balloon back within the stent valve and then re-inflated the balloon under rapid pacing.This was successful and there was an excellent result.The position of valve was good, there was no leak.

• 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: 17547851
• MDR Text Key: 321143507
• Report Number: 2015691-2023-15254
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240801(10)64481430
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMMANDER DELIVERY SYSTEM
• Device Lot Number: 64481430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male