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

Model Number 9750CM29A

Device Problems Inflation Problem (1310); Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

Device not returned.Investigation is ongoing.

Event Description

As reported, during deployment, the distal end of the balloon expanded a remarkable amount more than usual.The implanter addressed concerns of the valve potential embolizing aortic as a result of this issue.Withdrew the system without difficulties.No patient injury occurred.

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the field clinical specialist, this was a transfemoral tavr procedure with a 29mm sapien 3 ultra resilia valve implanted in the native aortic annulus.During deployment with nominal volume, the distal end of the commander delivery system balloon "expanded a remarkable amount more than usual.The implanter addressed concerns of the valve potential embolizing aortic as a result of this issue." post deployment the valve was in an 80:20 aortic/ventricular position, with no paravalvular leak and no central leak by echo.Post dilation was not performed.There were no difficulties withdrawing the delivery system.There was no patient injury.Intra-procedural cine images received were reviewed by engineering, and per the preliminary observations: the crimped valve appeared to be tilted and not fully aligned within the markers prior to deployment.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.The device was not returned to edwards lifesciences for evaluation.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 event is not required at this time.The complaints for "inflation difficulty and/or incomplete inflation" and "valve not between alignment markers and deployed" were confirmed through the provided video.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.A review of the dhr and lot history did not reveal any indication that a manufacturing non-conformance contributed to the reported events.In addition, a review of ifu/training materials also did not reveal any deficiencies.As per event description, "in a transfemoral tavr procedure with a 29mm sapien 3 ultra resilia valve, the distal end of the commander delivery system balloon expanded a remarkable amount more than usual." per training manual, the user is instructed to check if the valve is between the valve alignment markers prior to thv deployment.In this case, the provided video revealed tilted crimped thv, and the valve not fully aligned between the valve alignment markers prior to deployment.This could have caused the reported event of asymmetrical inflation, in which the balloon initially inflated from the distal shoulder before the proximal side started to be inflated.As such, available information suggests that user error (not following instructions) may have contributed to the complaint events.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• 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: 17888884
• MDR Text Key: 325851059
• Report Number: 2015691-2023-16619
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)250508(10)65069615
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM29A
• Device Lot Number: 65069615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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: Male