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

Model Number	14000ES14A
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
As reported by the field clinical specialist (fcs), during the transfemoral transcatheter aortic valve replacement (tavr) procedure with a 26 mm sapien 3 ultra valve, post successful valve deployment, a pinhole was noted in the 14fr esheath optima when it was withdrawn from the patient.It was believed to have been caused by the calcium nodule after the in-sheath dilator (isd) was used to help with diffusing the disease in the anatomy.There was no patient injury.
Additional Manufacturer Narrative
A supplemental mdr is being submitted to correct the reportability of the adverse event previously reported.The following sections of this report have been corrected/updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (device code and type of investigation), and h11 (additional narrative/data).The complaint device was returned for evaluation by edwards engineering.Evaluation of the returned esheath optima revealed periodic scoring on the outer jacket.There was also a scratch located 30 degrees from the periodic scoring.The outer jacket was peeled back and there was no puncture/pinhole observed on the inner shaft.In this case, the engineering evaluation confirmed the inner shaft of the sheath did not have a loss of integrity, as such, the potential for a vascular injury is remote as the valve would have not been exposed to the patient's body.In addition, it was confirmed that there was no patient injury.Therefore, this adverse event is no longer considered fda reportable.

• Brand Name: EDWARDS ESHEATH OPTIMA 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: 22195868
• Report Number: 2015691-2025-04794
• Device Sequence Number: 9275009
• Product Code: DYB
• UDI-Device Identifier: 00690103220629
• UDI-Public: (01)00690103220629(17)251022(11)250423
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K244046
• 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): 07/31/2025

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 Expiration Date: 10/22/2025
• Device Model Number: 14000ES14A
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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