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

Model Number 9610TF26U

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by an edwards spain affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, the valve 'embolized' due to a mix of loss of pacing capture and valve alignment difficulties with the valve on the commander delivery system balloon due to the patient anatomy (horizontal aorta).The valve got caught at the aortic root.A second 26mm sapien 3 ultra valve was used inside to secure it with great outcome good hemodynamics.

Manufacturer Narrative

Correction to h6 based on additional information.The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The procedural video was provided and the following was observed: valve not centered on the inflation balloon.Distal portion of the balloon seem to have slightly expanded prior the proximal portion of the balloon.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 valve not aligned between markers and deployed, was confirmed by review of provided imagery.As reported 'during procedure, the valve 'embolized' caused by a mix of loss of capture of pacemaker and bad alignment of valve over the commander delivery system balloon.The valve was not properly aligned for unknown reasons'.Per imagery review, the valve was not aligned prior to valve deployment.Misaligned thv on inflation balloon does not follow the instructions per training manual; 'before deployment, ensure that the thv is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker'.Failure to follow instructions can result in the balloon inflating distally and leading to the observed asymmetrical expansion of the thv.As such, available information suggests that procedural factors (misaligned valve on inflation balloon prior to deployment) may have contributed to the complaint event.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.

• Brand Name: COMMANDER DELIVERY SYSTEM
• 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: 16500231
• MDR Text Key: 310984978
• Report Number: 2015691-2023-11322
• Device Sequence Number: 1
• Product Code: NPT
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

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: 05/09/2024
• Device Model Number: 9610TF26U
• Device Lot Number: 64367229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/07/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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