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

Model Number 9610TF26U

Device Problem Material Rupture (1546)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in germany, regarding a 26mm sapien 3 ultra valve implant inside a surgical valve in aortic position by transfemoral approach.During procedure, while deploying the valve the balloon of the 26mm commander delivery system radially burst at the end of the inflation.No valve post dilation was needed, there was good result with no pvl.The commander delivery system was successfully retrieved from patient through the esheath.No component was missing on the commander delivery system after removal.However, when inspecting the esheath, it was found that the esheath distal tip was torn.Patient outcome was good post procedure.

• 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 ; 9492506385
• MDR Report Key: 18856349
• MDR Text Key: 337744837
• Report Number: 2015691-2024-01670
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103208078
• UDI-Public: (01)00690103208078(17)250731(11)230801
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Lot Number: 65231041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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 Age: 75 YR
• Patient Sex: Male