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

Model Number 9750CM23A

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate, regarding implantation of a 23mm sapien 3 ultra valve in the aortic position.The 23mm commander delivery system balloon ruptured during deployment of the valve after fully inflating.The team attempted to retrieve the commander delivery balloon back into the sheath and but was not successful.Per pictures provided, balloon pieces were separated.The sheath was split along the expandable seam of the sheath.The team opted to do a cut down procedure to remove the devices.A distal aorta-bifemoral graft procedure was performed.The patient was reported as fine and no other complications were noted.

• 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: 18804256
• MDR Text Key: 336509288
• Report Number: 2015691-2024-01435
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM23A
• Device Lot Number: 65281103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2023
• 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 Sex: Female