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

Model Number 9610TF29

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 01/04/2023

Event Type  malfunction  

Event Description

As reported from our affiliates in germany, this was a case of a 29mm sapien 3 valve in aortic position by transfemoral approach.After successfully implanting the 29mm sapien 3 valve, there were difficulties removing the commander delivery system through the esheath, despite the commander delivery system being completely deflated and unflexed.The commander delivery system was pulled too hard, and it was torn with the balloon catheter left inside the esheath and the outer catheter withdrew from the esheath.The system was finally removed as a single unit.At the final angiography, it was confirmed that the patient did not have any damage on the femoral artery.The patient outcome was good.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Updated h3, h6-device code.Pre-decontamination evaluation of the returned device showed the balloon was torn at the i/c bond location and the balloon material was bunch at the distal tip.There was no component separation.As the balloon was found to have been torn during withdrawal after the valve was deployed, this event is no longer considered reportable, and this correction is being submitted.

• 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 Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16188855
• MDR Text Key: 308143672
• Report Number: 2015691-2023-10247
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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