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

Model Number	916ESPA
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
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, resistance was felt during insertion of the valve with delivery system through the 16fr esheath+, and the valve got caught within the partially expandable.A bent tine was noticed on fluro.The devices were removed and replaced.The procedure was successful.Per report, there may have been interaction with the esheath+ when removing the 25mm tru balloon causing issues getting into and back through the sheath.Per device image received, the esheath+ has a sheath puncture with the bent valve tines exposed through the puncture site.
Additional Manufacturer Narrative
Investigation is still ongoing.

• 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: 25488660
• Report Number: 2015691-2026-15999
• Device Sequence Number: 21312697
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)271105(11)251105
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/17/2026

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: 67143480
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 07/17/2026
• 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: Unknown