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

Model Number 9610TF26U

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 11/08/2023

Event Type  Injury  

Event Description

As reported by an edwards lifesciences affiliate in france, regarding a 26 sapien 3 ultra in aortic position by transfemoral approach.During the procedure while performing valve alignment, the 26mm commander delivery system catheter was pulled and the fine adjustment wheel was rotated at the same time.This caused to the wheel to be over rotated and the delivery system balloon was below the valve, near the pusher.When withdrawing the commander delivery system and valve there was a femoral complication.A cutdown was performed to retrieve the devices from the patient.A second system was prepared, and the patient successfully received a 26mm sapien 3 ultra valve implanted.

Manufacturer Narrative

Investigation is underway.H3 other text : not returned.

Manufacturer Narrative

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.Imagery was provided for review by the site and revealed the following: failed attempt to withdraw the dislodged thv by pulling partially inflated balloon through dislodged thv.Guidewire appears curved, indicating non-coaxial withdrawal.Cutdown performed to remove dislodged thv from patient.The reported events were confirmed through review of the provided imagery.In this case, there was no allegation of device malfunction contributed to the reported event.Additionally, a review of the complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Per event description, while performing valve alignment, the catheter was pulled and the fine adjustment wheel was rotated at the same time, which led into wheel was over rotated and the balloon was below the valve and near the pusher.When withdrawing the commander delivery system and valve there was a femoral complication and it was needed to perform a cutdown to retrieve the devices from the patient.Procedural training manual provides indication on how to perform valve alignment.It also states warning: do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.As such, it is likely that the crimped thv was over aligned, potentially during fine adjustment of the valve onto the inflation balloon.Over alignment of the thv can potentially cause the valve being positioned too distal on the inflation balloon.On the other hand, the over aligned thv appeared to have dislodged off the balloon during withdrawal, potentially due to the interaction between vasculature and crimped valve struts compounded with a non-coaxial withdrawal shown in imagery provided, which likely contributed on causing the reported vascular complication.Available information suggests that use error (over-rotation of fine adjust) may have contributed to the valve alignment difficulties, while procedural factors (crimped valve interaction with vasculature, non-coaxial withdrawal) may have contributed with the thv dislodged off balloon 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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is 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 (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506384
• MDR Report Key: 18293390
• MDR Text Key: 330065252
• Report Number: 2015691-2023-18232
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Lot Number: 65174884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Male