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

Model Number 9600LDS26A

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

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

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).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

During a transfemoral tavr procedure, a 26mm sapien 3 valve and commander delivery system were prepared without issue.The delivery system and valve were inserted into the 14fr.Esheath and positioned in the infra renal artery.The delivery system was unlocked, and gross alignment was attempted.The system would not align and became ¿fixed¿.An attempt was made with ¿a good amount of force¿; however, alignment was not possible.It was also noted that the valve was ¿slipping¿ on the delivery system.The decision was made to remove the delivery system, but the valve could not be pulled back into the sheath.A surgical cutdown of the right common femoral artery was performed to remove the delivery system and valve.A second esheath, delivery system and sapien 3 valve were prepared and successfully used.The second sapien 3 valve remains implanted in the patient.Mild access vessel calcification and moderate tortuosity were reported.The devices were not returned to edwards lifesciences for evaluation.

Manufacturer Narrative

Additional information: section h6: evaluation codes; section h10: narrative text.The 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.Review of the provided photographs of the device revealed the delivery system strain relief was located just distal to the default position.The unexpanded valve was attached to the delivery system.Slight damage was observed at the esheath distal tip.Review of the patient 3mensio report revealed the presence of calcification and tortuosity in the patient¿s vessels.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.Lot history review revealed no other similar complaints.Complaint history review from october 2018 through september 2019 for the commander delivery system (all models and sizes) revealed other similar complaints for the first reported event.Available information suggested patient and/or procedural factors may have contributed to the reported events.Complaint history review from october 2018 through september 2019 for the commander delivery system (all models and sizes) revealed other similar complaints for the second reported event.No manufacturing non-conformances were identified.Available information suggested patient and/or procedural factors may have contributed to the reported events.A review of complaint data for september 2019 revealed that the complaint rate did not exceed the control limit for the applicable complaint trend categories.Per the ifu and training manuals in a straight section of the vasculature, initiate valve alignment by disengaging the balloon lock and pulling the balloon catheter straight back until part of the warning marker is visible.Do not pull past the warning marker.Warning: to prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.Engage the balloon lock.Use the fine adjustment wheel to position the valve between the valve alignment markers.Caution: do not turn the fine adjustment wheel if the balloon lock is not engaged.Do not position the valve past the distal valve alignment marker.This will prevent proper valve deployment.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.Before deployment, ensure that the valve is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker.During the manufacturing process, the delivery system components undergo multiple 100% inspections.During final inspection, the entire assembled delivery system undergoes visual inspections and functional testing.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-conformances contributed to the reported events.In this case, the complaints were confirmed based on the review of the provided imagery of the device.However, without a returned device, a manufacturing non-conformance was not able to be determined.Investigation of complaint history, review of dhr and lot history revealed no indication that a manufacturing non-conformance contributed to the 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 reported, there was no abnormality during device prep, suggesting that there was no issue with the device when removed from packaging.As reported, valve alignment was attempted in the patient and following removal of the system, attempted outside of the patient.The system could not be moved, and gross alignment could not be achieved.Although no further functional testing could be performed due to unavailability of a returned device, the complaint device from this reported event may be related to a locking mechanism issue that was previously identified and investigated in a capa in which the locking mechanism found on the balloon shaft is engaged even though in the unlocked state.However, without the returned device, this failure cannot be confirmed.Slight damage also noted on the sheath distal tip, indicating that the delivery system/valve may have been caught at the sheath tip during delivery system retrieval.It is possible that non-coaxial retrieval of the delivery system into the sheath occurred as influenced by retrieval in a tortuous vessel or the presence of calcification.Although a definite root cause cannot be determined, procedural factors (non-coaxial withdrawal), in addition to patient factors (vessel calcification/tortuosity) may have contributed to the reported withdrawal difficulties and the subsequent surgical cutdown to remove the initial delivery system and valve.No labeling inadequacies were identified, and the occurrence rate did not exceed the applicable control limit.No corrective or preventative action is required is required at this time.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: section h10: narrative text.As reported by a tavr patient through a social media posting, the tavr procedure was complicated.I was led to believe the device malfunctioned.I still have some lumps in the area of surgery on the artery after one year, and actually it is beginning to cause some mild discomfort.It started recently, after the one year check up with the tavr team.Other than that, i am able to build stone walls by hand and other strenuous activities without a problem.I feel great otherwise and would recommend your device.Further information regarding possible actions taken is not available at this time.Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 if additional information becomes available.

• 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: 9146766
• MDR Text Key: 163127725
• Report Number: 2015691-2019-03656
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/18/2019

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: 07/14/2021
• Device Model Number: 9600LDS26A
• Device Lot Number: 62429001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 11/17/2019; 10/08/2020; 07/23/2020
• Supplement Dates FDA Received: 11/20/2019; 11/03/2020; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR