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

Model Number 9610TF29

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by an edwards lifesciences affiliate in canada, regarding a 29mm sapien 3 transcatheter heart valve implant in aortic position by transfemoral approach, during thv deployment, the commander delivery system balloon burst at the end of inflation.The native valve was known to be heavily calcified.The thv was able to be fully deployed and was working well.However, the operators were unable to remove the balloon through the esheath.When attempting to remove the balloon, it caused an accordion effect.Surgical cutdown had to be performed to fix the femoral artery.The patient was well at the end of the procedure.As per physician opinion, the root cause of the burst balloon was calcium spear.As per predecontamination evaluation of the returned device, there was missing commander delivery system balloon material.

• 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: 18905412
• MDR Text Key: 337680584
• Report Number: 2015691-2024-02006
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)250627(11)230628
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Lot Number: 65169677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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: 78 YR
• Patient Sex: Male