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

Model Number 9600LDS29A

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

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

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.This is one of three manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-07459 and 2015691-2022-07460.

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral tavr, there was resistance between a 29mm s3 valve/delivery system (ds) and the 16fr esheath plus.As reported, there were no issues inserting the 16fr esheath plus into the abdominal aorta.Then 29mm valve and delivery system were inserted.The eye of fluoro was looking at the distal end of the esheath in the abdominal aorta waiting for the delivery system to push through.It was then noticed that delivery system was being pushed further in, but the team was not seeing the delivery system move up.The eye was moved down to the groin where it was seen what appeared to be the delivery system with the valve pushed out of and through the esheath, as well as into external iliac (it was an up down and back up loop-to-loop).The delivery system and esheath were pulled back.An angioplasty balloon was placed into the abdominal aorta.The physicians were unable to remove the esheath, and delivery system with valve.The esheath and delivery system were removed via surgical cutdown.They then placed several stents to treat the right femoral artery dissection.The patient underwent a bilateral groin cutdown and fasciotomy to be able to repair the groin and ensure blood flow and life to the extremities.Upon removal of the devices, bent struts were noted on the valve and the valve was wasted.The patient was transferred to icu for recovery.

Manufacturer Narrative

Supplemental report submitted to include to correct the h6 and h10.The complaint of withdraw delivery system with valve through vasculature does not apply to this complaint based on the evaluation and returned imagery.Upon receipt, investigation indicated that the valve and delivery system never fully advanced though the sheath, as evidence by the unopened sheath tip.The investigation also did not confirm any device defects or manufacturing non-conformances on the delivery system that may have contributed to the reported event.Although the delivery system and valve were exposed though the sheath when withdrawal difficulties were noted, it was the lack in sheath integrity that allowed for this exposure to patient anatomy.Additionally, no non-conformances were mentioned regarding the delivery system specifically.This event is no longer mdr reportable.

• 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 dorn ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15272654
• MDR Text Key: 298385790
• Report Number: 2015691-2022-07461
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240522(10)64387645
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Device Catalogue Number: N/A
• Device Lot Number: 64387645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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 Sex: Male