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

Model Number 9750CM26A

Device Problem Failure to Advance (2524)

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

Event Date 06/27/2022

Event Type  Injury  

Event Description

As reported, during a transcatheter aortic valve replacement (tavr) procedure using a 26 mm sapien 3 ultra valve via transfemoral approach, they used a 16 fr esheath to begin the case due to patients tortuous thoracic aorta and tortuous iliac arteries.The valve and delivery system were difficult to build and the operator loaded more than half of the balloon into the valve before it became stuck.The operator tried to deploy the valve in the annulus by partially inflating then adjusting balloon during same pacing run to complete deployment.The balloon would not retract back into valve and as the operator was attempting to pull the balloon back into valve, the valve embolized into the ascending aorta.The doctor, retracked the valve to a straight portion of the thoracic aorta and deployed the valve.A second valve and deployment system was prepared and the valve was successfully deployed in the annulus.

Manufacturer Narrative

Investigation is ongoing.Device remains in patient.

Manufacturer Narrative

H2, h6 updated the delivery system was not returned; therefore, a visual inspection, functional testing, or dimensional testing was not performed.Imagery was provided by the site and revealed the following: patient access vessel exhibited tortuous iliac arteries and tortuous thoracic aorta.A device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to navigate and position catheter to target location valve alignment difficulty or inability fine adjust, navigate and position catheter to target location valve alignment difficulty or inability gross alignment and valve deployment valve not between alignment markers and deployed.As the complaints for valve deployment valve not between alignment markers and deployed, navigate and position catheter to target location valve alignment difficulty or inability gross alignment and navigate and position catheter to target location valve alignment difficulty or inability fine adjust were unable to be confirmed, a complaint history review is not required.No device was returned and there is no evidence to support a manufacturing/design defect potentially contributing to the complaint, therefore a manufacturing mitigation review is not required.The following instructions for use (ifu) were reviewed: commander with s3 ifu (us), device preparation manual and procedural training manual.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The complaints for valve deployment valve not between alignment markers and deployed, navigate and position catheter to target location valve alignment difficulty or inability gross alignment and navigate and position catheter to target location valve alignment difficulty or inability fine adjust were unable to be confirmed as the complaint device was not returned and no applicable imagery was provided.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing nonconformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing nonconformance would have contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.As reported for complaint codes navigate and position catheter to target location valve alignment difficulty or inability fine adjust & navigate and position catheter to target location valve alignment difficulty or inability gross alignment: the valve and delivery system were difficult to build, the doctor loaded more than half of the balloon into the valve before it became stuck.Additionally, 3mensio imagery was returned and showed that the patient exhibited tortuous thoracic aorta.If valve alignment was performed in a tortuous (nonstraight section) vasculature, this can cause the valve to become unseated (noncoaxial placement of valve in relation to the flex tip) and dive into the flex tip.If the thv is unseated from the flex tip during alignment, it can result in higherthannormal alignment forces creating high tension in the system which can consequentially lead to the reported fine adjustment difficulties of only being able to load the valve onto half of the balloon.Additionally, under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.The study revealed that performing valve alignment in a curvature appears to increase the possibility of diving (thv become unseated from the flex tip), which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.A definitive root cause is unable to be determined.Available information suggests patient (tortuosity) and/or procedural factors (valve alignment in nonstraight section) may have contributed to the reported event.As reported for complaint code valve deployment valve not between alignment markers and deployed: the doctor tried to deploy the valve in the annulus by partially inflating then adjusting balloon during same pacing run to complete deployment.Unfortunately, the balloon would not retract back into valve and as he was attempting to pull the balloon back into valve, the valve embolized into the ascending aorta.Per the training manual, user must make sure the thv is exactly between the valve alignment markers.Due to the reported valve alignment difficulty, it is possible, the user did not fully align the valve with the valve alignment markers prior to deployment.If not aligned correctly, improper deployment of the valve can occur, just as described in the complaint description.A definitive root cause is unable to be determined.Available information suggests procedural factors (valve deployed when not aligned between markers) may have contributed to the reported event.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions (capa) are required.Since no product non conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) escalation is not required.In this case, patient factors (tortuous aorta) and/or procedural factors may have contributed to the valve was implanted in a nontarget location, the ascending aorta.Valve deployment in unintended location is listed in the instructions for use (ifu) as a potential risk associated with the tavr procedure, the bioprosthesis, and the use of its associated devices and accessories.There may be cases in which the valve is not able to be deployed at the intended location for various reasons.This may require deploying the valve at a nontarget location.

• 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: 15065342
• MDR Text Key: 296228037
• Report Number: 2015691-2022-06873
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)240320(10)64297361
• 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
• Report Date: 08/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Model Number: 9750CM26A
• Device Lot Number: 64297361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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 Sex: Male