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

Model Number	916ESPA
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by a field clinical specialist (fcs), during a tmvr procedure with a 29mm sapien 3 ultra resilia valve in an existing non-edwards surgical valve, during the procedure the team was advancing the 1st delivery system through the 16f esheath plus.The team noticed the sheath was starting to kink.The team noticed some resistance.The team pulled back and tried to advance with same result.The team tried again and the system came through the sheath.We replaced the entire system and successfully placed the valve.There was a small vein dissection.The team threw the entire system away.Per fcs evaluation of photos, it was indicated the damage to the sheath observed most similarly resembled both liner puncture through the dynamic expansion and liner strand.The system was pushed on and during this time the sheath may have been manipulated and the device, on the image, came through the side.When visualizing, it tore through the dynamic expansion.The 1st sheath was no inserted at a steep angle and there were no insertion difficulties.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to additional information from a product investigation.The following sections of this report have been updated: b4, g3, g6, h2 and h6.The events reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure modes are not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the instructions for use (ifu), training manuals and current risk mitigations have been reviewed.No inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.In this case, liner puncture and liner strand were empirically confirmed.Available information suggests that procedural factors (device manipulation) likely contributed to the event as it was reported that ''the system was pushed on and during this time the sheath may have been manipulated and the device, on the image, came through the side.'' high push forces exerted to overcome resistance in challenging anatomy can compromise sheath integrity, resulting in punctures.Forceful device maneuvers can damage the sheath components in direct contact with rigid anatomical features (e.G.Sharp calcium nodules).When combined with non-coaxial advancement trajectories (rendered through anatomical complexities and/or manual device misalignments), these forces can further exacerbate damage to the liner - particularly when interacting with crimped valve struts.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS ESHEATH PLUS SHEATH 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: 25045841
• Report Number: 2015691-2026-14827
• Device Sequence Number: 9643135
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)271202(11)251202
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 916ESPA
• Device Lot Number: 67266590
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male