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

Model Number 9610TF26U

Device Problems Failure to Align (2522); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2024

Event Type  Injury  

Event Description

As reported by an edwards australia affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, as the operator aligned the valve in the commander delivery system balloon, the valve overshot the distal marker, and was pushed up to the nose-cone.This was due to additional turns on the wheel that the operator accidentally made during final adjustment in the descending aorta.It was decided to cross the valve with a misaligned devices.However, attempts to cross the valve annulus were unsuccessful, and it was noticed that the distal part of the valve frame was flared a bit.It was decided to deploy the valve in the descending aorta.The valve was deployed without any complications.A second valve was successfully implanted in the aortic annulus.The patient was transferred to the icu in stable condition for monitoring overnight, and was discharged 72 hours later.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

Correction to h6 based on additional information.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.In this case, the reported event of valve alignment difficulty and difficulty to cross native annulus were unable to be confirmed due to the unavailability of the returned device and/or applicable imagery.However, without applicable procedural imagery, a definitive root cause is unable to be determined.As such, available information suggests that user error (over rotation of the fine adjust) may have contributed to the complaint event.Per report, the degree of calcification predominantly in the non coronary cusp was moderate heavy.Calcification may cause constrained sections of the anatomy that interferes with passage of the delivery system and causes difficulty during tracking.Additionally, the crimped thv was aligned too distal and 'pushed up to the nose cone.This over alignment can cause the thv to go over a larger portion of the inflation balloon leading to valve struts flared out at the inflow side.It is possible that the flared inflow struts could have caught on the native valve calcification and resulted in the reported resistance.However, without applicable procedural imagery, a definitive root cause is unable to be determined.As such, available information suggests that patient factors (calcification) and/or procedural factors (valve aligned too distal) may have contributed to the complaint event.There may be cases where the valve cannot be deployed at the intended location.This may require deploying the valve at a non target location.Although well tolerated, the long term effects are not completely understood.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is 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: 18822915
• MDR Text Key: 336731726
• Report Number: 2015691-2024-01547
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Lot Number: 65103989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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 Outcome(s): Required Intervention