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

Model Number 9600LDS23A

Device Problem Burst Container or Vessel (1074)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.H3 other text : device not returned.

Event Description

As reported by a field clinical specialist, during the implant of a 23 mm sapien 3 ultra valve in the aortic position via transfemoral approach, the fully inflated balloon ruptured on tightly calcified sinotubular junction.It was unable to advance into sheath and was also unable to be pulled out of the femoral arteriotomy as the device was getting caught on the horizontally ruptured balloon.A vascular surgeon performed a cut down.There were portions of the balloon that were unaccounted for outside of the patient.The team did a runoff angiography and it looked like pieces of the balloon were still in the iliofemoral system.The surgeon stented the balloon in place inside of the patient from the common iliac to the common femoral.

• 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: 18950450
• MDR Text Key: 338252723
• Report Number: 2015691-2024-02163
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female