MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH PLUS INTRODUCER SHEATH

Model Number	916ESPA
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is three of three manufacturer reports being submitted for this case.The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during implant of a 29 mm sapien 3 ultra resilia (s3ur) valve in the aortic position, there were multiple issues during the procedure.The first 29 mm s3ur was deployed at 90/10 (70/30 after deployment) and embolized into the ascending aorta due to a loss of capture.The valve then caught on the commander delivery system balloon and pulled back into the arch and left there as it was unable to be tracked into the descending aorta.The balloon was inflated multiple times while trying to retrieve the embolized valve.The commander delivery system balloon then would not go back into the 16f esheath+ as it was bunched up (not torn or burst) so it was removed as one unit.A new 29 mm s3ur valve and system were prepped and delivered successfully.At the end of the procedure the non-edwards closure devices were lost, so crystal was placed for hemostasis and vascular surgery was called.A surgical cutdown and repair of the femoral artery was completed.The patient was in stable condition in icu following the procedure.After removal of the devices, the commander delivery system balloon was found to be bunched up and there was damage to the 16f esheath+.Ti's unknown what damage was found on the esheath+.Per an imagery review completed by edwards engineer, a liner delamination was noted.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• Common Device Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• 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: 25116128
• Report Number: 2015691-2026-14989
• Device Sequence Number: 13324333
• Product Code: NPT
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)271212(11)251212
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: 67299630
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• 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