MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS ESHEATH PLUS INTRODUCER SHEATH; 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	05/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 1 of 2 reports the investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist (fcs), during a tavr procedure with a 23mm sapien 3 ultra valve in the aortic position, the first valve got caught in the esheath.The entire system was removed and a 2nd valve and delivery system was placed with good result.During delivery system introduction into sheath, the valve would not advance in the sheath.It was noticed that a tine of the valve was lifted away from prepped system and was catching in the sheath.Upon follow up, the fcs advised that during a tavr procedure, no difficulty was encountered during insertion of the esheath, and the expansion tool (esheath+) and loader were used appropriately with full insertion achieved.The esheath was introduced via right-sided access at a steep angle.The delivery system and valve did not exit the sheath, becoming lodged near the transition between the blue and white portions of the sheath.The system was withdrawn from the patient as a single unit, and inspection identified a small pinhole in the sheath.The device had been prepared and the valve crimped per ifu, with no issues during the crimping phase.No vessel pre-dilation was performed.The original system was removed and replaced with a new system to complete the procedure.The patient remained stable with no reported injury.The event was attributed to insertion of the delivery system at a steep angle during sheath access.The device was retained by the hospital and was not available for return; no images of the device were provided.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 25256658
• Report Number: 2015691-2026-15458
• Device Sequence Number: 5431911
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)280113(11)260113
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/29/2026

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: 67389812
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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: Unknown