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

Model Number 9750CM23A

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)

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

Event Date 03/06/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was discarded by the hospital.

Event Description

As reported by the field clinical specialist (fcs), during a left transfemoral tavr procedure, the 23mm commander delivery system balloon ruptured during deployment.Per report and before deployment, a balloon aortic valvuloplasty (bav) was performed with a 18mm true balloon.A 23mm sapien 3 ultra valve was implanted in the native aortic annulus with nominal volume.During deployment, the delivery system balloon ruptured once it was inflated due to calcium at the stj (sinotubular junction).There were no issues with the valve.Post deployment, there was no paravalvular leak and post dilation was not performed.The operating team was unable to withdraw the delivery system back into the esheath+.A vascular surgeon was called into the procedure, and a left iliac surgical cut down was performed to remove the esheath+ and commander delivery system as a unit.The iliac artery was then closed and no other issue noted.The commander delivery system is not available for return as it was discarded.Reportedly, the patient is still intubated at postoperative day 1.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 19003870
• MDR Text Key: 338907410
• Report Number: 2015691-2024-02435
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)251009(10)65344994
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 65344994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2023
• 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: 75 YR
• Patient Sex: Female