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

Model Number 9750CM29A

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 02/15/2024

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 29mm sapien 3 ultra resilia valve in the aortic position, the delivery system balloon burst at the end of inflation.The physicians obtained bilateral groin access, right arterial, left arterial and left venous without issue.Right transfemoral (tf) access was obtained for the esheath+.Pigtail and temp pacer placed on the left side.The 29mm s3ur commander delivery system (ds) entered into the esheath+ without issue.Achieved native valve crossing without issue.During valve deployment, the ds balloon burst occurred at the end of inflation.The team paused to view echo imaging and felt there was no need for post dilation.The team proceeded forward with trying to remove the ds balloon.Partial balloon was pulled back into the esheath+ and resistance was felt.The operator pulled the delivery system into the esheath+ and noticed kinking in the sheath, however continued to pull the system with resistance.The ds balloon was very challenging to remove, and the operators were unable to fully pull the balloon into the sheath.The team pulled the sheath and ds out of the vessel, but the balloon tip and torn portion remained in the vessel at the access point.The vascular team was called for cutdown and vessel repair.The access site required cutdown due to removal of balloon.The patient required 3 units of blood due to the bleeding.The perceived root cause of the vessel tear was the delivery system balloon.The valve is functioning well, and the patient is stable.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted due to device image review, sections g6, h2, h6: device codes have been added to the device codes previously sent.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 18852647
• MDR Text Key: 337070742
• Report Number: 2015691-2024-01664
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)251213(10)65449174
• 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,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM29A
• Device Lot Number: 65449174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2023
• 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: Male