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

Model Number 9750CM26A

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

Patient Problem Unspecified Vascular Problem (4441)

Event Date 02/28/2024

Event Type  Injury  

Event Description

As reported by an edwards lifesciences field representative, during a right-transfemoral transcatheter aortic valve replacement procedure with a 26mm sapien 3 ultra valve, the 26mm commander delivery system balloon ruptured at max inflation using nominal volume.The perceived root cause of the balloon burst was calcification at the sinotubular junction.During delivery system withdrawal, the balloon would not retract into the 14fr esheath+.Preexisting contralateral access was utilized to snare the balloon tip, allowing for retraction of the delivery system into the sheath.Cutdown was performed to surgically close the vessel as "the sheath end was much larger than standard case" and the operator did not want a bleeding complication.The sheath and delivery system were removed as a unit.Upon removal, it was noted that the sheath had full delamination.It was also noticed that a portion of the delivery system balloon remained in the body.The balloon material was found at the access site and was ultimately retrieved from the arteriotomy and surgical closure with a patch was successful.All balloon material was accounted for and successfully removed from the patient.The patient was discharged without issue.

Manufacturer Narrative

Investigation is ongoing.

• Brand Name: 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: 18940942
• MDR Text Key: 338133256
• Report Number: 2015691-2024-02131
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)250925(10)65294135
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Lot Number: 65294135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2023
• 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: 64 YR
• Patient Sex: Male