MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS ESHEATH PLUS INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	914ESPA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is 2 of 2 reports.Investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), a 26 mm edwards transcatheter heart valve sapien 3 ultra resilia was implanted in the aortic position.The valve was reported to be successfully implanted, with no central leak observed, and the patient was alive at the end of the procedure.During the procedure, a device-related malfunction was encountered involving the commander delivery system.During post'dilatation, the balloon ruptured at 6 atmospheres and 24 cc, consistent with reported characteristics of both a balloon burst and balloon tear (p1 and p2).There was no retained volume in the balloon.The physician noted the event may have been possibly related to bulky left ventricular outflow tract (lvot) calcium.Following the rupture, there was difficulty withdrawing the balloon into the 14fr esheath, despite coaxial alignment upon reentry, full unflexing of the delivery system, and the flex tip positioned at the triple marker.Due to the inability to withdraw the system, the physician elected to remove the delivery system and esheath together as a single unit, which required a surgical cutdown.During removal, resistance was encountered at the arteriotomy site, and it was observed that the proximal portion of the balloon had separated from the distal portion appears to be a circumferential tear.Due to the distal segment of the balloon, there was inability to withdrawal the delivery system through the esheath.A surgical cutdown was required to remove the entire system including the attached distal part of the balloon and nose cone from the patient's access site.Upon removal of the system, the segment was noted to be bunched or accordioned intraluminally at the common femoral arteriotomy site, contributing to the retrieval difficulty.Photos were provided and the balloon burst appears to have been circumferential, as the distal part of the balloon had detached from the proximal section, but was still attached to the nose cone of the ds and required removal by a surgical cut down along with the rest of the commander ds.Additionally, damage to the esheath was observed, with the tip appearing torn/split and described as split in half but not detached.No other edwards devices were reported as damaged.Following successful surgical removal of the retained balloon segment, the common femoral artery was closed per standard surgical technique, and the procedure was completed without complication.No use error leading to patient injury was reported.Photos of the device condition were reported as pending via separate communication, and a 3mensio report was noted as available.The involved device was discarded and is not available for return.Upon additional follow up, the esheath had damage as the distal end was split.

• 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: 25210456
• Report Number: 2015691-2026-15311
• Device Sequence Number: 13380234
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)271113(11)251113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/02/2026

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: 67203571
• 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: 07/02/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2025
• 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