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

Model Number	916ESPA
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist, this was a complex aortic repair with 3 fenestrations.Lumens appeared open on ct so right tf was attempted.A 16f esheath+ was advanced with no issues; however, it was not long enough to go above graft.The commander delivery system and 29mm s3 valve were advanced, and the valve had issues exiting the tip of the esheath.Changing angle on the tip of the sheath/ pin and pull technique were used.Eventually the 29mm s3 valve was advanced past esheath+ and valve alignment was successful.Upon the valve going over the arch, the interventional cardiologist saw something that looked like radiopaque material exterior to the valve itself seemingly attached to the valve.The delivery system and 29mm s3 valve were retracted successfully into esheath+ and removed from the body.The esheath+ was ripped at the tip; however, all appeared intact.There was no damage or bent struts visible to the valve.The esheath was cut to look for suspected piece of graft material but nothing was found.A second 16fr esheath+ was advanced with no issues.A second commander and 29mm s3 valve were advanced with no issues.Valve alignment was performed above the graft on this second attempt.The valve was deployed.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24832668
• Report Number: 2015691-2026-14026
• Device Sequence Number: 18431479
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)271121(11)251121
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/16/2026

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 Catalogue Number: N/A
• Device Lot Number: 67225712
• Was Device Available for Evaluation?: Yes
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2025
• 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: Male