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

Model Number	916ESPA
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two reports being submitted for this case.Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist, during a subclavian transcatheter mitral valve replacement procedure to implant a 29 mm sapien 3 ultra resilia valve into a pre existing surgical annuloplasty ring, the delivery system could not be advanced through the 16 f esheath+ and the valve had a bent strut.During the procedure, there was no difficulty inserting the esheath and the esheath was not inserted at a steep angle.However, due to using right subclavian vein access, more sheath was outside of the body than customary.The delivery system with valve became stuck in the middle of the fully expandable portion of the esheath.Resistance seemed to be more than usual prior to the system coming to a complete stop.It was then noted under fluoroscopy that a strut was bent up at a roughly 90 degree angle to the normal plane.The system was removed as a single unit.A new system was prepared and successfully deployed.There was no patient injury and the patient was in stable condition following the procedure.The cause of the event was unclear.The esheath was returned for evaluation and upon visual inspection a liner tear and liner strand were observed.

• Brand Name: EDWARDS LIFESCIENCES ESHEATH+ INTRODUCER SET
• 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: 25304474
• Report Number: 2015691-2026-15574
• Device Sequence Number: 9517880
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)270724(11)250724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2026

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: 916ESPA
• Device Lot Number: 66854159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 07/15/2026; 07/17/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 07/15/2026; 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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 Sex: Male