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

Model Number 9600LDS26A

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

As reported by the edwards field clinical specialist, during a transcatheter aortic valve replacement case with a 26mm sapien 3 valve, once the valve crossed the aortic valve, it was noted that the valve was not completely aligned on the balloon, but the decision was made to deploy.Once rapid pacing was initiated, the valve dove slightly into the ventricle.As the physician was deploying the valve, the valve embolized into the ventricle.The decision was made to open the patient, retrieve the sapien 3 valve, and implant a surgical valve.The patient had been prepped and draped in normal sterile fashion.The right axillary artery was accessed.The esheath+ was advanced into descending aorta.Device and delivery system were prepped in accordance with the ifu.The device was delivered to the ascending aorta and valve alignment was performed with the valve 0.5mm above the distal marker.The team released all the tension prior to deployment.There were no issues with alignment.There was no allegation of malfunction by the operator.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Updated h6-type of investigation, investigation findings, investigation conclusions.The device was not returned for evaluation.3mensio was provided and the following were observed: calcification and tortuosity were in access vessels present within the patient's anatomy.Calcification was present within the patient's aorta.The complaint for valve not being aligned between markers and deployed was unable to be confirmed as neither the complaint device nor applicable imagery was provided for evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.Due to unavailability of work order review of the dhr, lot history was not performed.Additionally, a review of the ifu and training manuals revealed no deficiencies.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.As reported , "once the valve crossed the aortic valve, it was noted that the valve was not completely aligned on the balloon.The valve dove slightly into the ventricle.Per case notes provided, they mentioned that there were no issues with alignment.Per training manual, "before deployment, ensure that the valve 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 improper deployment.Due to the valve not properly aligned between valve alignment markers the balloon inflated distally and led to the dislodgment.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 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 SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16383171
• MDR Text Key: 309662748
• Report Number: 2015691-2023-10836
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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 Model Number: 9600LDS26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female