MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH+ INTRODUCER; INTRODUCER, CATHETER

Model Number 916ESP

Device Problem Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, during insertion of the valve into the esheath+, the operator could not push the valve past the semi expandable portion.The forces were mentioned to be more than normal, so the devices were removed.A new 14 fr esheath+ was inserted, and a new valve was prepped and was advanced with no issue.Post deployment, a small dissection was noted in the femoral artery.The artery was ballooned with no issues and great results.Per report, this is the second time that this has happened at this institution.Is should be noted that as the fcs was getting the new delivery system and valve, the tech attempted to advance the valve out of the esheath resulting in the valve strut protruded through the esheath+.The device is being sent back as mentioned, however, it did not come out of the body in this form.

Manufacturer Narrative

This supplemental report is being submitted to retract the previously submitted medwatch report.It was initially reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 26mm sapien 3 ultra valve, during insertion of the valve into the esheath+, the operator could not push the valve past the semi expandable portion.The forces were mentioned to be more than normal, so the devices were removed.A new 14 fr esheath+ was inserted, and a new valve was prepped and was advanced with no issue.Post deployment, a small dissection was noted in the femoral artery.The artery was ballooned with no issues and great results.Per report, this is the second time that this has happened at this institution.However, per follow up report, the perceived root cause for the dissection was believed to be caused by pre ballooning the femoral artery with an 8mm peripheral balloon.The delivery system got stuck and was removed.The new sheath was inserted after ballooning the artery again.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• 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: 17326093
• MDR Text Key: 319098929
• Report Number: 2015691-2023-14580
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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