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

Model Number	914ESPA
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for the same event.Reference related manufacturer report # 2015691-2026-14625.The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a right-side transfemoral tavr (transcatheter aortic valve replacement) procedure with a 26mm sapien 3 ultra resilia (s3ur) valve in the native aortic position, there was some difficulty encountered when trying to advance the 26mm commander delivery system (ds) into the 14fr esheath+, at which point the nosecone of the ds exited through the seam of the esheath+.In response, the esheath+ was brought to a straighter segment of the patient's anatomy and the ds was rotated while entering the esheath+, which allowed the ds to successfully advance.An additional 2ml was added to the balloon of the ds prior to inflation.During valve deployment, the balloon to the ds burst due to the calcium burden.The s3ur valve was successfully implanted and the access site was closed without complication.The ds and esheath+ were removed as a single unit and are not available for return/evaluation.The patient is in stable condition.

• Brand Name: EDWARDS 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: 24998535
• Report Number: 2015691-2026-14706
• Device Sequence Number: 15892081
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)271204(11)251204
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/02/2026

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: 67226579
• Was Device Available for Evaluation?: No
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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: 79 YR
• Patient Sex: Male