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

Model Number 9610TF23U

Device Problems Inflation Problem (1310); Failure to Deflate (4060)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in germany, regarding an implant of a 23mm sapien 3 ultra valve in aortic position by right transfemoral approach.During the valve deployment, it was not possible to inflate the balloon.Only with unusual high pressure on the locking syringe, the balloon was deployed to a maximum of 40% in proximal part and 25% in distal part.It was tried to deflate the balloon, but also the deflation was very slow.It was tried again to expand the balloon with no success.Next attempt was to try to inflate the balloon with a perfusion syringe with no success.Then, it was prepared a new 25ml locking syringe to inflate the balloon with no success.Last try was done in locking mode until high pressure appears and then turn in.This worked and the balloon was successfully inflated.All these attempts were made under a long period of rapid pacing.The valve was in a good position, with no pvl and no gradient.The patient was noted as to be doing well with no neurological issues and in stable condition in the icu.

• 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: 18804117
• MDR Text Key: 336863694
• Report Number: 2015691-2024-01431
• Device Sequence Number: 1
• Product Code: NPT
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF23U
• Device Lot Number: 65240527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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