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

Model Number	916ESPA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 29mm sapien 3 ultra resilia valve, vascular closure was attempted but failed to achieve hemostasis after the valve was successfully deployed.Continued bleeding was noted, and manual pressure applied.Per report, the perceived root cause of the event was the 16fr esheath+ may have caused an arterial injury upon removal due to the distal tip of the esheath+ being split.The surgeon performed surgical cutdown, and the tissue tract was closed using the perclose device.However, there was a false sense of hemostasis prior to cutdown.Hemostasis was achieved surgically.The patient was stable and transferred to the intensive care unit.The 16fr esheath+ was prepped according to ifu.Per response from the territory manager, there was a distal tip tear observed on the device upon removal.
Additional Manufacturer Narrative
The event 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 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 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.The reported event for distal tip torn was confirmed and has been confirmed based on the information available to date.Any updates or additional findings will be submitted in accordance with fda reporting requirements.Sheath distal tip tears may result from a combination of multiple contributing factors.The tip expansion mechanism may be influenced by inherent variation in the manual tip scoring process, as documented in a product risk assessment and/or by other manufacturing-related factors being investigated in a capa.This event falls within the scope of a capa that was opened to further investigate potential contributing factors to the tip tear events.High push forces applied to overcome resistance during system advancement can further contribute to tip tearing.While multiple contributing factors have been identified, a definitive root cause is unable to be determined at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, no further actions are required at this time.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER
• 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: 24535936
• Report Number: 2015691-2026-12627
• Device Sequence Number: 21447211
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)270811(11)250811
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 66875733
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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