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

Model Number 9600LDS29A

Device Problems Failure to Align (2522); Malposition of Device (2616); Difficult to Advance (2920)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/05/2022

Event Type  Injury  

Event Description

As reported by an edwards field clinical specialist, during a subclavian tavr procedure, difficulties were encountered during the fine alignment of a 29mm sapien 3 valve on the commander delivery system balloon.Following multiple alignment attempts, the valve was between the between the middle marker and distal marker.It was believed that the valve was far enough on the balloon to deploy.During deployment, only the distal end of valve expanded.The valve was then crossed with a balloon.An attempt was made to move the valve to the ascending aorta, but it would not go around the arch.The decision was made to deploy the valve in the ascending aorta.The devices were removed, and the procedure was stopped.The patient was returned to surgery on postoperative day (pod) 2 for open surgery.The sapien 3 valve was explanted, and a surgical valve was placed.At the time of the report, the patient was in stable condition.

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.

Manufacturer Narrative

Corrected information: section h6.Additional information: section h10.The commander delivery system was returned to edwards lifesciences for evaluation.Functional testing, locking/unlocking and fine adjustment of the device was successfully performed with no issues noted.Flexion was also performed without issue.Due to the nature of the complaint, no applicable dimensional testing was able to be performed.Pre-decontamination observations indicated the delivery system was returned locked at the warning marker.The full loader assembly was over flex shaft.A severe bent on proximal of the balloon shaft likely due to packaging, was observed.The proximal balloon shaft was able to be unlocked and locked.Full fine adjust was able to be performed without issue.The inflation balloon was observed to be wrinkled.Review of the provided case imagery revealed the valve was diving into the flex tip.The valve was also not centered over the valve alignment markers during the valve positioning prior to inflation.Incomplete inflation of the valve was also observed.The valve was deployed in the ascending aorta.Functional/dimensional testing (successful locking/unlocking, successful fine adjust, successful flexion, locknut/collet engagement tensile test) performed on the returned device and demonstrates conformance to specification.Visual observations (sheath shaft compression) are not defects and do not suggest a product non-conformance.Therefore, an edwards manufacturing deficiency was not confirmed through returned device evaluation and the root cause of the event is likely attributed to patient/procedural factors.In addition, the event does not allege a labeling issue, therefore, a dhr is not required.Lot history review revealed no other similar complaints.In this case, the complaints for 'valve alignment difficulty or inability - fine adjust,' 'valve not aligned between markers and deployed,' and 'difficulty or inability to withdraw system with valve through vasculature' were confirmed by review of provided imagery.However, a manufacturing non-conformance was unable to be determined.Additionally, a review of the lot history and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, 'multiple attempts made to get the valve loaded between the markers.The valve was between the middle marker and distal marker.' it is possible that tension was introduced onto the delivery system and resulted in the reported multiple attempts to align the valve onto the valve alignment markers.The exact cause of tension is unknown.However, it is possible that valve alignment was performed in a tortuous (non-straight section) vasculature.This can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and 'dive' into the flex tip, as observed.If the thv is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces creating high tension in the system which can consequentially lead to the reported valve alignment difficulties.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.The study revealed that performing valve alignment in a curvature appears to increase the possibility of 'diving' (thv become unseated from the flex tip), which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.As reported, 'physician did not want to pull out the device and sheath and go with new valve.Felt like it was far enough on the balloon to deploy.After attempted deployment only the distal end of valve opened.' the instructions for use and training manuals instruct the user to 'ensure that the valve is correctly positioned between the valve alignment markers.' if the valve is not between the valve alignment markers as observed, it will not be oriented fully over the inflation balloon working length, leading to incomplete or asymmetrical deployment, as observed.As reported, 'the valve was then crossed by a balloon and attempted to move to descending aorta.It would not go around arch so it was determined to be deployed in the ascending aorta.The valve as deployed there.' tortuous patient anatomy could result in non-coaxial angles of withdrawal during system retrieval.It is possible that the non-coaxial withdrawal configuration may have resulted in the partially deployed thv interacting with patient vasculature and causing the reported withdrawal difficulty.Available information suggests in addition to procedural factors (valve alignment in non-straight section, built up tension), patient factors (vessel tortuosity) may have contributed to the alignment difficulties.Procedural factors (incomplete valve alignment, misaligned valve on inflation balloon) may have contributed to the valve deployment issue.Although a definite root cause of the withdrawal difficulties could not be determined, available information suggests that in addition to procedural factors (non-coaxial withdrawal, withdrawal of partially deployed valve), patient factors (tortuosity) may have contributed to the reported event.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 this adverse event is not required at this time.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: EDWARDS COMMANDER DELIVERY
• Type of Device: AORTIC VALVE, PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15625175
• MDR Text Key: 301921301
• Report Number: 2015691-2022-08653
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240704(10)64443921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

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 Model Number: 9600LDS29A
• Device Lot Number: 64443921
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male