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

Model Number 9600LDS29J

Device Problems Device Slipped (1584); Failure to Align (2522); Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); Injury (2348); Aortic Dissection (2491)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our affiliate in (b)(6), valve alignment difficulty and valve placement at incorrect location were reported.During a transfemoral tavr procedure, a 16fr esheath was percutaneously inserted via the left femoral artery.A 29 mm sapien 3 and commander delivery system were advanced, and valve alignment was performed in a ¿relatively straight¿ area of the descending aorta.Even though the fine adjust wheel was fully rotated, the valve could not be set in the proper alignment position.At that time, valve diving was observed.After unlocking the balloon catheter and rotating back the fine adjust wheel, valve alignment was attempted.The sapien 3 valve was slightly misaligned to the precise alignment position but it was judged ¿acceptable¿.During deployment, the distal side (left ventricle side) of the sapien 3 valve expanded first and the balloon slipped to the left ventricle; the proximal side (aorta side) valve expansion was ¿insufficient.¿ valve deployment in the aortic annulus was judged ¿impossible¿.The valve was pulled back and deployed in the descending aorta.A new sapien 3 valve and delivery system were prepped.Valve alignment was successfully performed while the vascular tortuosity was stretched with guidewire and pigtail catheter.The second valve was properly deployed in the targeted position.The access vessel minimum luminal diameter (mld) measured 6.2 mm x 6.6 mm with mild calcification.Moderate to severe access root tortuosity and vascular tortuosity in the lower extremity and area between the diaphragm and aortic arch.The native annular valve area measured 550.0 mm2 with moderate valvular calcification reported.The diameter of sinotubular junction (stj) measured 30.0 mm.The sinus of valsalva (sov) measured 35.0 mm.A narrow sov was reported.

Manufacturer Narrative

The initial commander delivery system was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.No applicable imagery was provided for review.Lot history review revealed one other similar complaint.The other complaint is pending engineering evaluation.Complaint history review indicated the occurrence rate did not exceed the august 2019 control limits for the appropriate trend category.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Per the ifu and training manuals slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap.Note: fine adjustment wheel functions only when the balloon lock is locked.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Compression may be observed in the distal portion of the flex catheter during valve alignment.Diving may be observed between the thv and the flex catheter tip during valve alignment.To correct: move to a different straight section of the aorta (for diving only).If using a balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible.If using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.Perform valve alignment in the straight section of the aorta the ifu and training manuals have been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.During the manufacturing process, the entire delivery system is visually inspected and tested multiple times.The delivery system components undergo multiple 100% visual and dimensional inspections.The entire device undergoes 100% distal to proximal final inspection by manufacturing and quality.Additionally, product verification (pv) testing is performed on finished devices under a sampling basis.These inspections during the manufacturing process support that it is unlikely that a defect in manufacturing contributed to the complaint event.There may be cases in which the valve is not able to be deployed at the intended location.This may require deploying the valve at a non-target location.Although, generally well tolerated, the long-term effects are not completely understood.In this case, the complaint was not able to be confirmed as no devices or relevant procedural imagery was provided.Review of dhr and lot history revealed no indication a manufacturing non-conformance contributed to the complaint event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.As mentioned in the description the patient had tortuous anatomy, additionally, valve diving was noted during the procedure.Performing valve alignment at a non-straight anatomy is likely to cause the valve to unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip and to ¿dive¿ into the lumen of the flex tip, where part of the crimped valve slid into the flex tip lumen.If the valve is unseated during alignment, it can result in higher than usual valve alignment forces.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high enough valve alignment forces to potentially cause the fine adjust difficulty reported in this complaint.The procedural training manual provides troubleshooting tips for valve diving.Additionally, residual volume left in the balloon may also contribute to increased forces during valve alignment.This was recreated in a previously performed engineering study, which demonstrated that residual volume in the inflation balloon during valve alignment can create high valve alignment forces.Although a definite root cause was not able to be determined, available information suggests in addition to procedural factors (valve diving), patient factors (access vessel tortuosity) may have contributed to the fine adjust difficulties and the asymmetrical expansion of the initial valve.The asymmetrical expansion of the valve may have contributed to the movement of the valve toward the left ventricle and subsequent relocation and deployment in the ascending aorta.The second sapien 3 valve was successfully deployed.No labeling inadequacies and no manufacturing nonconformance were identified during evaluation.Since no manufacturing non-conformances, labeling, training, or ifu deficiencies were identified, no corrective and preventative action is required at this time.

Manufacturer Narrative

Additional information received through the japanese tavi registry indicated on postoperative day (pod) 1, a descending aortic dissection was observed on ct.No actions were taken.The patient was placed under observation and follow-up with periodic cts.On pod25, the final ct confirmed improvement of the dissection.No intervention was required.Per the instructions for use (ifu) cardiovascular injury, such as perforation or dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure.Ascending aortic dissection may occur when multiple attempts are made to cross the stenotic native valve, and/or when excessive force is used.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 transcatheter heart valve (thv).The thv training manuals provide guidance to facilitate safe crossing of the native valve, including camera projections, handling during advancement, and troubleshooting techniques if difficulty is encountered.As stated, excessive force should not be used when the device has difficulty crossing the stenotic valve.Adding tension to the wire, pulling back the system to re-orient the valve, as needed, and torqueing of the flex catheter may be helpful in solving the problem.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate procedural factors (manipulation of the devices) may have contributed to the descending aortic dissection observed on pod1.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

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

• 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: 8917046
• MDR Text Key: 155174295
• Report Number: 2015691-2019-03101
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/31/2019

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: 02/11/2021
• Device Model Number: 9600LDS29J
• Device Lot Number: 61974673
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 02/04/2020; 07/23/2020
• Supplement Dates FDA Received: 09/30/2019; 02/24/2020; 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 46