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

Model Number	916ESPA
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral transcatheter aortic valve replacement (tavr) procedure using a 29 mm sapien 3 ultra resilia valve, there was slight difficulty encountered during the fine adjust portion of valve alignment.Valve alignment was attempted in a straight section of the anatomy.It was able to be resolved by unlocking and then re-locking.Subsequently, during valve deployment, there was non-uniform expansion of the valve.It was noted that while deploying the valve, the distal portion pointing towards the left ventricle (lv) opened significantly later than the proximal portion of the valve directed towards the aorta.The valve was reported to be between the markers before deployment.Ultimately, the valve deployed satisfactory.Post-deployment echocardiography showed the valve was fully expanded.The patient was transferred for recovery in stable condition.There was no patient injury.Per additional information received from the fcs, there was no damage observed on the delivery system and no damage observed on the esheath+.There was normal resistance during insertion of the delivery system with valve through the sheath.The inflation was intentionally slower and deflation was normal.The device was not torqued during the procedure.There were no difficulties withdrawing the delivery system and/or sheath.There was no fluid loss noticed.Imagery was received for evaluation.Per review of the procedural fluoroscopy imagery, the transcatheter heart valve (thv) appeared to be positioned between the valve alignment markers prior to deployment.The video shows approximately 10 seconds of inflation and ends before full inflation is reached.It does not show the full deployment cycle (inflation and deflation) time.The balloon inflated asymmetrically for approximately the first 7 seconds of inflation, with the distal end appearing constrained.The distal constraint was then overcome and the distal end of the thv began to expand.After the constraint was overcome, there appears to be a c-shaped shadow near the distal end, resembling a torn and separated sheath tip.
Additional Manufacturer Narrative
A supplemental report is being submitted for correction and to include additional information from the investigation.The following sections of this report have been corrected/updated: h6 (type of investigation, investigation findings, investigation conclusions) and h11 (additional narrative/data).The events reported are 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 is not required at this time.The device was not returned for evaluation as it was discarded.Due to the unavailability of the device, no visual inspection, functional testing, or dimensional analysis could be performed.There was imagery received for evaluation.Per review of the procedural fluoroscopy imagery, the transcatheter heart valve (thv) appeared to be positioned between the valve alignment markers prior to deployment.The video shows approximately 10 seconds of inflation and ends before full inflation is reached.It does not show the full deployment cycle (inflation and deflation) time.The balloon inflated asymmetrically for approximately the first 7 seconds of inflation, with the distal end appearing constrained.The distal constraint was then overcome and the distal end of the thv began to expand.After the constraint was overcome, there appears to be a c-shaped shadow near the distal end, resembling a torn and separated sheath tip.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, the torn esheath+ distal tip and separated esheath+ tip were confirmed based on review of the provided imagery.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 tip scoring process and/or by other manufacturing-related factors.Additionally, patient or procedural factors, such as challenging anatomy or non-coaxial advancement angles, may exacerbate interference between the valve and distal tip, leading to increased resistance and potential tearing during system advancement.In this case, the patient's access characteristics could not be confirmed.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 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+ INTRODUCER 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: 24592081
• Report Number: 2015691-2026-13183
• Device Sequence Number: 9440600
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)271105(11)251105
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/30/2026

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
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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