MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF29

Device Problems Burst Container or Vessel (1074); Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

Per pre-deco engineering observation, the delivery system balloon was torn at the i/c bond.As reported by our (b)(6) affiliate, during a transfemoral procedure with a 29 mm sapien 3 valve in the aortic position, gross alignment difficulty was encountered in a tortuous descending aorta with a commander delivery system.There was difficulty aligning the balloon under the crimped valve.Troubleshooting maneuvers were unsuccessful and a decision was made to remove the entire system including the sheath.A second system was used, and the valve was successfully implanted.There was no report injury to the patient.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

Manufacturer Narrative

The commander delivery system was returned to edwards for evaluation.Visual inspection revealed the following: y-connector not returned and was cut, kink on guidewire lumen (likely due to packaging condition), guidewire lumen detached from delivery system (inserted through sheath), balloon torn proximal i/c bond, valve appears to have shifted distally over the inflation balloon pumpkin near the distal nose tip, gouges on flex tip, and the valve outflow struts are slightly bent likely due to interaction with flex tip during valve alignment.Functional testing was performed during pre-decontamination and the delivery system was able to pull the valve alignment marker with no difficulties experienced and the fine adjust wheel was rotated with no issues observed.Dimensional testing was performed on the double wall thickness of the crimp balloon near the tear and was found to be within specification.During manufacturing, the delivery system and component are both visually inspected and tested several times throughout the process.During crimp balloon final inspection, the balloons are 100% dimensionally and visually inspected per procedure.All balloons are inspected visually and dimensionally for defects per procedure.The inflation balloon and crimp balloon bond is inspected for defects.Prior to balloon pleat, fold and forming process, the balloon is 100% visually inspected.During final inspection, the entire device is visually inspected distal to proximal and includes fine adjust function.The commander delivery system is 100% leak tested and post-leak test there is 100% visual inspection of the balloon catheters.In addition, product verification (pv) testing is performed for visual damage, device insertion, fine adjustment verification and balloon tensile testing.All tested samples must pass the testing for lot release.These inspections support that it is unlikely that a manufacturing non-conformance contributed to the reported complaints.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that could have contributed to the event.A lot history review was performed and revealed no other complaints relating to the complaint.A review of the complaint history from (b)(6) 2019 to march revealed other returned complaints for the commander delivery system (all models).However, no manufacturing non-conformances were identified during the investigations of the similar complaints.Available information suggests that the complaints were related to patient and/or procedural factors.A review of complaint history revealed that the occurrence rate did not exceed the (b)(6) 2020 control limit for all the trend categories.The ifu for edwards delivery system, prepping manual, and training manual were reviewed for instructions involving esheath and commander preparation and procedure.The training manual provides guidance on valve alignment.Unlock, pull the balloon catheter straight back at the y-connector until part of the warning marker is visible and lock, do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, rotate the balloon lock away from you to lock and towards you to unlock.Lock/unlock symbols are found on the balloon lock, and check delivery system before valve alignment.If kinked, do not use.In addition, the warning marker indicates the balloon catheter is approaching a hard stop (do not pull past the warning marker), slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap, fine adjustment indicator shows how much fine adjustment is left and if additional fine adjustment is needed, unlock and rotate the fine adjustment wheel away from you until part of the warning marker is visible and relock.A gap between the thv and distal valve alignment marker may result in difficulty crossing, and an overlap cannot be reversed and may prevent proper thv deployment.Fine adjustment wheel functions only when the balloon lock is locked, and do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.Thv moves in only one direction relative to the balloon, additional consideration include: compression may be observed in the distal portion of the flex catheter during valve alignment, and diving may be observed between the thv and the flex catheter tip during valve alignment.To correct the diving between the thv and the flex catheter, move to a different straight section of the aorta (for diving only), if using the balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible, and if using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.The complaints were confirmed based on visual inspection of the device.No manufacturing non-conformances were identified during device evaluation as no abnormalities were observed during visual inspection, dimensional measurements and functional testing.Furthermore, a review of lot history, complaint history, manufacturing mitigations, and the dhr did not provide any indication that a manufacturing non-conformance contributed to the event.A review of ifu/training materials revealed no deficiencies.Complaint history suggests that patient factors such as tortuosity can contribute to the reported events.Tortuosity was reported as present in vessels, ¿during gross alignment in the little tortuous descending aorta¿.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.Flex tip gouges were observed on the returned devices which are indicatives of high valve alignment force and tension occurred during valve alignment step.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a product risk assessment.If the physician performed valve alignment in a non-straight section of the aorta, it may have resulted in increased forces being applied to the bond area.In addition, residual volume left in the balloon may also contribute to increased forces during valve alignment, which could lead to a weakening of the inflation and crimp balloon bond.Another previously performed engineering study was able to recreate high enough valve alignment forces to potentially cause a material failure in the area in question.In this case, available information suggests that patient (tortuosity) and/or procedural (valve alignment in non-straight section of the aorta) factors may have contributed to the complaint events.However, a conclusive root cause is unable to be definitively determined.No ifu/training manual deficiencies were identified, and review of complaint history revealed that the occurrence rates for the applicable trend categories did not exceed (b)(6) 2020 respective control limits.Therefore, neither pra escalation nor corrective actions are required at this time.The complaint of balloon torn was confirmed based on the visual inspection of the returned device.No manufacturing nonconformities were identified during the evaluation.Available information suggests that procedural (high alignment forces) factors may have contributed to the complaint event.However, a definitive root cause could not be determined at this time.Per management discretion, the balloon torn issue and it associated risks have previously been assessed and documented in a product risk assessment.No ifu/training material deficiencies were identified.Regardless, edwards previously decided to include additional information that currently exists in the training manuals, into the ifu per a capa.The content consists of instructions relative to device preparation and minimizing the tension in the device, which may potentially lead to delivery system damage during use.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 29MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9969756
• MDR Text Key: 188672944
• Report Number: 2015691-2020-11492
• Device Sequence Number: 1
• Product Code: NPT
• 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,Followup
• Report Date: 02/28/2020

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 Expiration Date: 12/11/2021
• Device Model Number: 9610TF29
• Device Lot Number: 62835092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 05/29/2020; 07/23/2020
• Supplement Dates FDA Received: 05/29/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1