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

Model Number 9610TF26U

Device Problem Inflation Problem (1310)

Patient Problem Foreign Body Embolism (4439)

Event Date 02/26/2024

Event Type  Injury  

Event Description

As reported from germany by our edwards lifesciences affiliate, during deployment of a sapien 3 ultra valve in aortic position by transfemoral approach, there were inflation/deflation issues of the 26mm commander delivery system balloon.The inflation/deflation time was 7.3s.The slow inflation/deflation time had also been noted during prep.The long inflation/deflation time ended with a loss of capture, leading the valve to embolize into the aorta.The procedure was converted to surgery.The patient underwent successful surgery and has been discharged home.

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: 18938224
• MDR Text Key: 338067861
• Report Number: 2015691-2024-02128
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103208078
• UDI-Public: (01)00690103208078(17)250913(11)230914
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Lot Number: 65281281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• 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 Age: 75 YR
• Patient Sex: Male