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

Model Number	916ESPA
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by a field clinical specialist, during a transfemoral transcatheter aortic valve replacement procedure using a 29mm sapien 3 ultra resilia valve, preclosing the artery was challenging due to the patient's large body habitus, and insertion of the esheath was difficult while tunneling through a long, resistant tissue tract and into the artery.Once the esheath was fully inserted, the transcatheter aortic valve replacement procedure proceeded as planned, and a 29 mm sapien 3 ultra resilia valve was successfully deployed.Insertion of the delivery system was met with moderate resistance.Upon removing the delivery system, there was significant resistance coming back through the esheath.Under fluoroscopy, it appeared that the radiopaque cuff of the esheath was no longer at the distal tip of the esheath, but rather mid sheath with the delivery system.The decision was made to remove the delivery system and esheath together.A 20mm dryseal was then introduced at the site and the vascular surgery team was called.Upon removal of the esheath and delivery system, it was identified that the inner lining of the esheath separated from the outer lining and buckled on itself.Vascular surgery repaired the arteriotomy via surgical cutdown and the patient was transferred to ccu in stable condition.Follow up from the fcs indicated that it was a working theory that the esheath possibly kinked on insertion but we did not confirm this on fluoroscopy at the time.

• 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: 25233242
• Report Number: 2015691-2026-15378
• Device Sequence Number: 5081653
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)270226(11)250226
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/01/2026

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: 66374187
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 136 KG