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

Model Number 9610TF26U

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Intraoperative Pain (2662)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in france, it was a case of an implant of a 26mm sapien 3 ultra valve, in aortic position by transfemoral approach.The native valve was not pre-dilated.During the procedure, valve alignment was performed in a straight section of the aorta without any difficulty.Nominal volume was used for inflation of the balloon of the commander delivery system, but it burst at the end of valve deployment.The valve was implanted in the correct position without embolization.As the balloon burst circumferentially, it was not possible to reintroduce it in the sheath, leading to withdrawal difficulties.This event was painful for the patient.It was tried to use a snare with cross lateral femoral but without success.It was decided to call a vascular surgeon to remove the yellow nosecone and the balloon of commander delivery system that were separated, by cutdown.The valve was post-dilated to be sure to avoid an incomplete valve expansion.After the procedure, the patient outcome was good, but gradient was high (26mm hg) detected by echography.A new scan was requested.As per medical opinion, the root cause of this event was a material defect.

• 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: 18842714
• MDR Text Key: 336956865
• Report Number: 2015691-2024-01617
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103208078
• UDI-Public: (01)00690103208078(17)250724(11)230725
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 65207222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Date Device Manufactured: 07/25/2023
• 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: 57 YR