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

Model Number	914ESPA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 23mm sapien 3 ultra resilia valve in aortic position.During the procedure, the initial valve and commander got stuck in the esheath near the right common/external iliac bifurcation.The physician was unable to advance the valve any further after changing angles and reattempting to advance.The valve did not exit the tip of the esheath and there was no damage on the sheath.The system was removed as one unit and a new esheath, delivery system, and valve were prepped.The second valve also got stuck at the same spot, and the physician noticed that the partially expandable part of the sheath had "popped off" or had become disconnected internally from the sheath hub but the outer layer was still connected to the hub.After multiple attempts, a different physician was called into the room and they were able to advance the valve through the esheath to deploy successfully.The team did add propofol through the side port on the last attempt that was successful.Once the device was removed, the strain relief disconnected entirely.The perceived root cause of the event is not known.All devices were prepared per the ifu and the vessels were pre-dilated to 16fr.There was no difficulty inserting the esheaths into the patient, the expansion tool was used, and the loader was able to be fully inserted into the sheath housing.The esheath was not inserted at a steep angle.There was no patient injury during the procedure.The provided post-procedural device photos were reviewed and showed separation of the sheath shaft from the hub, with the strain relief stretched over the proximal edge of the shaft.No strain-relief material or shaft material was visible within the hub.
Additional Manufacturer Narrative
Investigation is ongoing.

• Brand Name: EDWARDS ESHEATH PLUS
• Common Device Name: 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: 24791832
• Report Number: 2015691-2026-13860
• Device Sequence Number: 21001957
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)271119(11)251119
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: 914ESPA
• Device Lot Number: 67203574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 06/20/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female