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

Model Number 9610TF26U

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.

Event Description

Edwards received notification from our affiliate in australia.As reported, a patient underwent an implant of a 26mm sapien 3 ultra valve, on aortic position by transfemoral approach.During insertion of the commander delivery system through the esheath, the commander ''kinked'' on the distal part of the introducer proximal to the loader.Both devices were removed as a unit with valve through the sheath.A new kit used and the valve was implanted successfully.There was no harm to patient.Per medical opinion, there was failure to do short firm advancing movements while introducing the delivery system through the esheath.As per pre-decontamination evaluation of the delivery system, the balloon was found to be torn at the ic bond.

Event Description

Edwards received notification from our affiliate in australia.As reported, a patient underwent an implant of a 26mm sapien 3 ultra valve, on aortic position by transfemoral approach.During insertion of the commander delivery system through the esheath, the commander kinked on the distal part of the introducer proximal to the loader.The degree of calcification and tortuosity was minimal.During withdrawal, the balloon was not fully deflated and was torn as it was pulled through the sheath.Both devices were removed as a unit with valve through the sheath.A new kit used and the valve was implanted successfully.There was no harm to patient at any time.As per medical opinion, there was failure to do short firm advancing movements while introducing the delivery system through the esheath.

Manufacturer Narrative

Supplemental report submitted to include additional information received through follow-up.Updated b5.Based on the additional information provided, this complaint is no longer considered to be a reportable event.In this case, during insertion of the commander through the esheath, the commander kinked (flex shaft cracked per engineering) on the distal part of the introducer proximal to the loader.During withdrawal, the balloon was not fully deflated and was torn as it was pulled through the sheath.The devices were removed as a unit.New kit used and valve prepped and implanted.There was no report of patient injury.In cases where the delivery system balloon is damaged after successful deployment of the valve (as it was in this case), there is no risk of valve embolization.This event is no longer mdr reportable.

• 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: 14569325
• MDR Text Key: 300787017
• Report Number: 2015691-2022-05985
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 64097468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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