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

Model Number	916ESP
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 establishment name: (b)(6).The investigation is ongoing.
Event or Problem Description
As reported by our canadian affiliates, during implant of a 29'mm sapien 3 ultra resilia in the aortic position via a right transfemoral artery, resistance was encountered during insertion of the delivery system when exiting the tip of the esheath+.Once the delivery system reached the tip of the sheath, a distal tip tear to the esheath+ was noted and a portion of the distal tip was found to be missing.The valve was successfully implanted.The esheath+ was subsequently removed without difficulty.The patient remained in stable condition throughout the procedure.It is believed the tip of the esheath+ could still be in the patient, however there is no plan to follow the patient.An unsuccessful effort was made to locate the tip using fluoroscopy.The sterile field was also searched, and the tip was never located.Provided imagery shows the esheath liner expanded and the distal tip torn.Tip material was observed to be missing.

• Brand Name: EDWARDS 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: 24742053
• Report Number: 2015691-2026-13692
• Device Sequence Number: 17266033
• Product Code: DYB
• UDI-Device Identifier: 00690103217148
• UDI-Public: (01)00690103217148(17)270820(11)250820
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 916ESP
• Device Lot Number: 66938456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• 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: 03/09/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 77 YR
• Patient Sex: Male