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

Model Number	916ESPA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by a field clinical specialist, a patient underwent a transfemoral transcatheter aortic valve replacement (tavr) procedure with a 29mm sapien 3 ultra resilia valve in aortic position.The first esheath was found to have damage to the introducer dilator tip after it was removed from the patient, prior to introduction of the delivery system and valve deployment.The patient was noted to have tortuous and calcified access.Some resistance was encountered during sheath insertion, at which point the implanter stopped and withdrew the device.The skin incision was adequate, and the insertion angle was not steep.A second esheath was opened, prepared, and used successfully, allowing the valve to be delivered without issue.Inspection of the second esheath tip revealed no damage.A non-edwards wire was used to facilitate sheath insertion due to the tortuous nature of the right femoral artery.There was no patient injury.The perceived root cause of the damage was due to patient anatomy.The provided device-related photo was reviewed, and noted that the introducer tip appears split along one side, and there is visible curvature present on the introducer.
Additional Manufacturer Narrative
Investigation is ongoing.

• Brand Name: 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: 24550072
• Report Number: 2015691-2026-12677
• Device Sequence Number: 20256060
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)271111(11)251111
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/26/2026

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
• Device Lot Number: 67199732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• 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
• Patient Sex: Male
• Patient Weight: 102 KG