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

Model Number 9610TF23U

Device Problems Burst Container or Vessel (1074); Difficult or Delayed Positioning (1157); Failure to Align (2522); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

As reported by an edwards lifesciences affiliate in finland, difficulty with valve alignment occurred during a transfemoral tavr procedure with a 23 mm sapien 3 ultra valve.The patient has a remarkable tortuous and twisted anatomy in the descending aorta.A body wire was needed to help with the tortuosity, but still it looked very challenging.After valve alignment, tension (diving) was observed in the system.They tried to find a straighter section in the aorta to release the tension and reverse fine tuning and adjustment again between the markers they were able to track the device through the aortic arch despite tortuous and twisted anatomy.Once they reached the annulus area, it was seen on images that the marker of the valve was more proximal than in the middle of the balloon.As the valve was more proximal, it was decided to pull back the pusher and relief the tension of the delivery system.They started to inflate very slowly, observing the valve height.During slow inflation, ¿it was seen that the valve situated very near of the balloon tip of the system.¿ once there was contact with the annulus they changed to a moderate inflation.When they did that, the balloon glided towards the ventricle and the balloon burst.The valve was implanted but there was incomplete valve expansion in the outflow area of the valve crown.The balloon was removed successfully with no surgical intervention required.There were no missing pieces.Post dilation of the valve resulted in complete expansion and in good position (90:10 aortic/ventricular in bicuspid valve) with no paravalvular leak.The patient was doing well post procedure.Per medical opinion, the patient¿s anatomy was too tortuous for a safe valve alignment and valve alignment was not exact and maybe it was one of the main reasons for the balloon glide and failure.

Manufacturer Narrative

The product was not returned for evaluation.No imagery was provided.A device history record (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The complaint history was been reviewed and no confirmed manufacturing non-conformances were identified.The ifu, device preparation training manual, procedural training manual, and procedural manual were reviewed for guidance involving delivery system usage.Per ifu, 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.Do not position the thv past the distal valve alignment marker to minimize the risk of improper thv deployment or thv embolization.Before deployment, ensure that the thv is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker.The instructions for use (ifu), device preparation and the training manual were reviewed and no deficiencies were identified.During the manufacturing process, the device was visually inspected and tested several times.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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.The complaints for delivery system were unable to be confirmed as neither the complaint device nor applicable procedural imagery was provided.As a result, the presence of manufacturing non-conformances was unable to be determined.A review of lot history, dhr, and manufacturing mitigations supported that a manufacturing non-conformance likely did not contribute to the event.A review of ifu/training materials revealed no deficiencies.As mentioned in the case notes, the patient¿s anatomy was heavily tortuous.Tortuosity can lead to increased forces necessary to conduct valve alignment.Additionally, as per the event description, ¿it was noticed that it is difficult to find any place where the delivery system could line in a straight part of the aorta.Still they wanted to go on and they did valve alignment in the place where, so they said, was less curve.¿ if valve alignment was performed at a bend or angle, it 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.The complaint description notes this occurrence, stating that ¿after valve alignment, tension (diving) was seen in the system.¿ if the thv is unseated during alignment, it can result in even higher valve alignment forces.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Per the complaint description, tension was noted after valve alignment, which is likely due to valve alignment in a non-straight section of the aorta, although an attempt was made to try to realign in a straighter section.The complaint description also notes, ¿they did go through the aortic arch, even if it was tortuous and twisted and reach the annulus area, it was seen, that the marker of the valve was more proximal than in the middle.¿ navigation through the tortuous anatomy could have also contribute to the build up of tension.When the flex tip was eventually pulled back, ¿the tension of the delivery system relaxed clearly.¿ a previous investigation to document the valve movement on balloon issue and its associated risks for the commander delivery system with the s3 valve was initiated.In the investigation, build-up of tension within the delivery system during the procedure (e.G.Via valve alignment in a non-straight section, torqueing of the system, patient tortuosity, etc.) was identified as a possible cause of valve movement on balloon.As the issue identified in this complaint is similar in root cause and risks, this investigation is applicable.As per the complaint event description, ¿they calculated/analyzed the valve height and started to inflate very very slowly, in the same time observing the valve height.It was seen that the valve situated very near of the balloon tip of the system.When the annulus contact was reached they changed to a moderate inflation.When they did that, the balloon started to glide towards ventricle and burst when reaching the incomplete valve expansion in the outflow area of the valve crown.¿ if the valve was not centered on the balloon during inflation, it is possible that the sudden increase to moderate inflation could have caused the balloon to inflate unevenly, where the area that the valve is not located inflates faster and has an increased profile that can push against the valve struts and lead to a burst.However, without procedural imagery to review, a definitive root cause cannot be determined.As such, the available information suggests that patient (tortuosity) and procedural factors (valve alignment in non-straight section of aorta / balloon interaction with a displaced valve) may have contributed to the reported event.However, a definitive root cause was unable to be determined.Due to the unavailability of the device, it cannot be determined if a manufacturing non-conformance contributed to the reported events.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, any excursions above the control limits are assessed and documented as part of this monthly review.Since no product non-conformances or ifu/training deficiencies were identified during the evaluation, no product risk assessment, 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: 9554095
• MDR Text Key: 194933795
• Report Number: 2015691-2020-10037
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2019

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: 09/23/2021
• Device Model Number: 9610TF23U
• Device Lot Number: 62617638
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 02/27/2020; 07/23/2020
• Supplement Dates FDA Received: 02/28/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1