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

Model Number	914ESPA
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the field clinical specialist (fcs), during implant of a 23 mm sapien 3 ultra resilia valve in the aortic position via left transfemoral approach, during inflation of the commander delivery system while deploying the valve, there was asymmetrical inflation and delay of inflation occurred at the distal portion of the balloon.The valve was successfully deployed with no patient injuries due to the inflation problems.The patient was stable and awaiting vascular repair for a non-edwards closure device injury.Per imaging review, esheath+ distal tip tear and system components separate were found.
Additional Manufacturer Narrative
This is two of two manufacturer reports being submitted for this case.The investigation is ongoing.
Additional Manufacturer Narrative
H6 investigation findings: separation problem: the event reported is an 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 mode is 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 ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Provided procedural fluoroscopic imagery as well as the 3mensio, revealing calcification in the patient's left access vessel/abdominal aorta.In this case, the complaints for sheath distal tip torn and system components separate during use were confirmed based on evaluation of the provided procedural fluoroscopic imagery.The capa investigation has determined that esheath/esheath+ tip expansion performance may be influenced by patient specific anatomical factors, procedural factors, and manufacturing related variables.As part of this investigation, manufacturing evaluations identified opportunities for improvement that may further support consistent tip expansion, including under challenging anatomical and procedural conditions.These manufacturing improvement opportunities include defining axial outer diameter score depth requirements and adding procedural controls to reduce inner diameter surface damage, thereby supporting more robust and consistent tip expansion.Patient and/or procedural factors ' such as challenging anatomy or non-coaxial advancement ' may further exacerbate interference between the valve and distal tip, leading to increased resistance and potential tearing during system advancement.High push forces applied to overcome resistance during system advancement can further contribute to tip tearing and subject it towards separation.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.An investigation has been opened to determine the root cause and implement any necessary corrective actions.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• 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: 24746546
• Report Number: 2015691-2026-13719
• Device Sequence Number: 8780497
• Product Code: DYB
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K200258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 914ESPA
• Device Lot Number: 67066660
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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 Age: 65 YR
• Patient Sex: Female