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

Model Number 9600LDS26J

Device Problems Difficult or Delayed Positioning (1157); Failure to Align (2522); Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problem Aortic Dissection (2491)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards affiliate in (b)(6), during a transfemoral tavr procedure, the operator reported resistance during valve alignment, the 26mm sapien 3 valve moved on the balloon during deployment and the patient ultimately sustained an injury to the descending aorta.During valve alignment, the physician felt resistance and noticed the flex catheter was compressed.Although tension could be felt, the 26mm sapien 3 valve was able to be aligned correctly.When the valve crossed the aortic annulus and the flex catheter was pulled, the valve moved towards the aorta.As approximately 80% of the valve appeared to be on the balloon, and the physician opted to inflate the balloon.As the ventricular side of the balloon started to inflate, the valve migrated toward the aorta, while the balloon slipped back towards the left ventricle.The physician wanted to deploy the valve then in the descending aorta; however, the flex catheter could not be pulled, and the valve was not able to be pulled back onto the balloon.After the physician unlocked the flex catheter, the valve was able to be pulled onto the balloon.The diameter of the aorta was confirmed with the radiology department and judged as approximately 26mm.The valve was deployed with less than 1ml from nominal.Post deployment the patient became hemodynamically unstable.Angiography of the descending aorta revealed an aortic dissection.Percutaneous cardiopulmonary support (pcps) was started, and the patient was later placed on extracorporeal membrane oxygenation (ecmo).A stent graft was deployed in the descending aorta; however, hemostasis was not achieved, and a second stent was deployed.The sapien 3 valve was then implanted successfully in the aortic annulus.Once hemostasis was achieved, the patient became stable.It is perceived that the valve might have been oversized as the diameter of the descending aorta was confirmed through 3mensio to measure approximately 20-22mm.Additionally, it is possible that during the de-airing process, the balloon was inflated more than 20-30%, or the contrast agent remained inside of the balloon.

Manufacturer Narrative

Section h10: 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 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, the descending aortic dissection was likely cause by procedural factors (device manipulation).

Manufacturer Narrative

Section h6 and h10: the delivery system was not returned to edwards lifesciences for evaluation, as it was discarded by the facility.Imagery was provided by the site for review and the following observations were made: after insertion of the delivery system, while tracking up the descending aorta, the proximal (outflow) end of the valve appeared to dive and push against the flex tip.The flex shaft appeared to be under tension with a slight compression.When the delivery system tracked over the aortic arch, the valve appeared further compressed against the flex tip.The flex tip was folded against the flex shaft.After the valve was attempted to be deployed, the valve inflated only on the distal end.The valve was no longer between the alignment markers and shifted proximally.The proximal end of the valve was pushed against the flex tip and the delivery system was retracted back into the descending aorta.During manufacturing of the delivery system, the delivery system and components were inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.A device history record (dhr) review was performed and did not reveal any manufacturing related issues that would have contributed to the complaints.A lot history review was performed and did not reveal any similar complaints.A review of the complaint history from june 2019 to may 2020 revealed additional complaints for the reported failure modes.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.No manufacturing nonconformities were identified during the evaluation for the reported valve movement on balloon.A review of complaint data for may 2020 revealed that the complaint rate did not exceed the control limit for the applicable complaint trend categories.One manufacturing non-conformance (retaining ring of collet locking spring assembly unseated) was identified for the reported difficulty with valve alignment.The nonconformance had a limited severity as determined by risk assessment; therefore, a product risk assessment was not initiated.A review of complaint data for may 2020 revealed that the complaint rate did not exceed the control limit for the applicable complaint trend category.The instructions for use (ifu) for the commander delivery system (japan), the device prepping manual and the procedural training manual were reviewed for guidance and instruction on device preparation and usage involving the commander delivery system and esheath usage.No ifu/ training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are anticipated risks of the transcatheter heart valve procedure.Additional assessments of the failure modes are not required at this time.The complaints were confirmed by the provided procedural imagery.Without the complaint device returned, the presence of manufacturing non-conformances was unable to be determined.A review of lot history, dhr, complaint history 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 per the complaint event description, ¿it is possible that at the de-air process during the preparation, the balloon was inflated more than 20-30%, or the contrast agent remained inside of the balloon.¿ if the balloon was inflated with more than 20-30% fluid and/or residual fluid left inside the balloon during the device prep, it can enlarge the balloon¿s profile and cause difficulty with valve alignment.If the thv is ¿unseated¿ (non-coaxial placement of the valve in relation of the flex tip) from the flex tip during alignment and dove into the flex tip lumen, it can result in higher than normal alignment forces and can create tension in the system in order to achieve final alignment position.Valve diving into the flex tip and flex shaft compression are indicative of high tension in the system.An engineering study was previously performed to confirm this condition and was able to recreate high valve alignment forces with valve diving under simulated conditions.Per the device preparation manual, ¿do not inflate past 20-30% to maintain balloon shape for the procedure¿ and ¿ensure there is no residual fluid left in the balloon to avoid potential difficulty with valve alignment during the procedure.¿ furthermore, a build-up of tension in the system may contribute to the valve to move proximally.The observed movement of the valve on the balloon is likely a result of the subsequent release of tension by retracting the flex tip to the triple markers prior to deployment.Available information suggests that procedural factors (residual fluid from de-airing / enlarged balloon profile / built-up tension in system) may have contributed to the reported event.However, a definitive root cause was unable to be determined.The trending category did not exceed the monthly control limits and no labeling or ifu/training inadequacies were identified.As such, neither product risk assessment escalation nor corrective actions were required at this time.However, a product risk assessment was previously to investigate and document the valve movement on balloon issue and its associated risks and a capa was previously initiated to document the investigation and drive corrective/preventive actions as appropriate.No additional escalations were required at this time.

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; one edwards way; irvine CA 92614
• MDR Report Key: 10119632
• MDR Text Key: 194110677
• Report Number: 2015691-2020-12059
• 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,Followup
• Report Date: 05/14/2020

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: 02/03/2022
• Device Model Number: 9600LDS26J
• Device Lot Number: 62929618
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 07/16/2020; 07/23/2020
• Supplement Dates FDA Received: 07/16/2020; 07/16/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR