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

Model Number 9600LDS29J

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem Perforation of Vessels (2135)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

The device is to be returned for evaluation.Investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), a transcatheter aortic valve replacement (tavr) was performed via the right femoral artery.Valve alignment was attempted in the descending aorta, but the balloon catheter of 29 mm commander delivery system was not retracted and the fine adjust wheel was rotated.Changing the location in aorta, the operator tried alignment multiple times but could not move the valve to the alignment position.As the delivery system shaft gradually became bent, it was decided to remove the system.The devices were pulled back together as a unit, leading to common iliac artery injury.The patient went into hemorrhagic shock.After replacing the injured vessel with synthetic graft, the devices were surgically removed via laparotomy.Valve implantation was completed via the left femoral artery with a 29mm sapien 3 valve.The patient left the operating room in a stable condition.The devices are to be returned for evaluation.

Manufacturer Narrative

The device was returned for evaluation.Visual inspection showed the 29mm commander delivery system was returned locked at packaging position, no fine adjust nor flex was in use.The delivery system was returned without the valve.There are flex tip gouges, the loader cap was returned with the device, and there was no residual fluid observed in the balloon.During functional testing of the returned device, the following were performed and observed for locknut collet engagement force during pre decontamination device evaluation, the delivery system was pulled to valve alignment marker and locked.Full fine adjust was achieved without any resistance observed.During post decontamination device evaluation, the delivery system was locked at valve alignment marker.Force gauge was attached to the guidewire lumen port of the y connector.Valve alignment was performed and full fine adjust was achieved with no issues.Locknut collet engagement force meets the specification.Due to the nature of the complaint, no dimensional testing was performed.Patient imagery was provided and shows the conditions of the patients vessels which were noted to be have calcification and tortuosity.Tortuosity was present in the descending aorta, which is where the valve alignment and fine adjust procedures were being affected.Calcification was present in the area just distal to bifurcation area where device withdrawal occurred.Procedural cine was also provided and reviewed.The flex tip appeared to have entered the sheath tip while the thv was still outside of the sheath tip.The valve was non coaxially aligned with sheath distal tip during retrieval maneuvers.The valve was able to enter partially and caught at the sheath distal tip.The sheath appeared to be buckling as the valve strut interacts with the distal end of the sheath and prevents any additional movement on the thv.Valve not centered between alignment markers and non coaxially aligned with sheath distal tip.Thv being retrieved and caught onto sheath distal tip.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the complaint.During manufacturing, the device is both visually inspected and tested several times throughout the process.Inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the reported complaints.The following instructions for use (ifu) and training manuals were reviewed for guidance instruction involving the esheath and delivery system usage ifu for commander delivery system, device preparation training manual and procedural training manual.In a straight section of the descending aorta, initiate valve alignment by disengaging the balloon lock and pulling the balloon catheter straight back until part of the warning marker is visible.Do not pull past the warning marker.Caution if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.Engage the balloon lock.Use the fine adjustment wheel to position the thv between the valve alignment markers.Caution do not use the fine adjustment wheel if the delivery system is not locked at the valve alignment marker.Caution do not position the thv past the distal valve alignment marker.This will prevent proper valve deployment.Caution maintain guidewire position during valve alignment.Advance the delivery system and cross the aortic valve.Use the flex wheel as necessary.Caution verify that the edwards logo is facing up.The delivery system articulates in a direction opposite from the flush port.If additional working length is needed, remove the loader by unscrewing the loader cap and peeling the loader tubing from the delivery system.Retract the tip of the flex catheter to the triple marker to set the thv position.Verify the correct position of the thv with respect to the aortic annulus.As necessary, utilize the flex wheel to adjust the co axiality of the thv and the fine adjustment wheel to adjust the position of the thv.Ensure that the thv is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker.No ifu or training deficiencies were identified.A review of complaint history on confirmed device complaints (returned and no product returned) from february 2019 to january 2021 revealed the similar complaints the commander delivery system (all models and sizes).Prior closed complaints with any of the codes below were reviewed for similar events and root cause identification.As the complaint was reported for valve alignment difficulty and functional testing of the returned device identified no issue with the handle component and its functionality, prior complaints related to handle related issues (recoil, rotating difficulty inability, engagement ability) are excluded from the review.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 the failure mode is not required at this time.Since no product nonconformances or ifu or training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective action preventative action (capa) are required.The reported events were confirmed based on provided imagery.No manufacturing non conformances were identified during the evaluation.No device defect was identified during functional testing of the returned device (valve alignment was achieved without issues).A review of dhr, lot history, and manufacturing mitigations supported that a manufacturing nonconformance likely did not contribute to the reported events.A review of ifu and training materials revealed no deficiencies.The patients aorta was noted as mildly calcified and tortuous.Performing valve alignment at a bend or angle (such as in a non straight section of the aorta) can cause the thv to unseat (non coaxial placement of valve in relation to the flex tip) from the flex tip during alignment and dive into the lumen of the flex tip, where part of the crimped valve slides into the flex tip lumen.If the thv is unseated during alignment, it can result in higher than usual valve alignment forces and can create tension in the system to achieve final alignment position.Gouges were observed to be present on the flex tip, which is indicative of valve diving during the procedure.Under simulated conditions (valve alignment performed in kink fixture to represent a tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.While a definitive root cause is unable to be determined, available information suggests that patient (valve alignment in tortuous anatomy) may have contributed to the reported event.The patient is noted to have mild calcification and tortuosity of the access vessel.This may contribute to a non coaxial withdrawal of the delivery system into the sheath.In this configuration, the valve can catch on the sheath distal tip and prevent any further withdrawal.Available information suggests that patient (calcification, tortuosity) and procedural factors (non coaxial withdrawal of crimped valve) may have contributed to the reported event.In this case, the reported common iliac artery injury was likely caused by device manipulation during withdrawal of the devices and or patient factors may have contributed to the complaint event (access vessels with observable calcification and tortuosity).

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11278953
• MDR Text Key: 230256743
• Report Number: 2015691-2021-01111
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194883
• UDI-Public: (01)00690103194883(17)211205(10)62816515
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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: No Information
• Device Expiration Date: 12/05/2019
• Device Model Number: 9600LDS29J
• Device Lot Number: 62816515
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 50