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

Model Number	14000ES14A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the field clinical specialist (fcs), during implant of a 23 mm sapien 3 ultra resilia valve in the aortic position, the surgeon used the 21f in-sheath dilator (isd) to predilate the sheath before putting in the commander delivery system.There was quite a bit of force while putting in the 21f isd.During the pre-dilation using the 21f the tip of the isd was able to progress past the iliac bifurcation in the abdominal aorta to the end of the sheath.When the physician removed the sheath at the end of the case, there was an iliac perforation.The surgeon thought perhaps predilating the sheath with the optima isd caused the perforation.The sheath did not have any visible damage.The surgeon put in a covered stent and controlled the perforation.The patient is stable and doing ok.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for completion to the engineering evaluation.The following sections of this report has been updated: update to b4, g3, g6, h2, h6, h11.The product was not returned; therefore, a no product return investigation was completed.As a device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.Provided imagery was reviewed and the following were observed: undersized vessel region ('5.5mm minimum luminal diameter required for use of 14f esheath optima).Calcification present in the patient's access vessels.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The esheath optima ifu was reviewed.Precautions include, 'the sheath temporarily enlarges to allow the passage of devices; ensure that the vasculature can accommodate the maximum diameter of the expanded sheath.Caution should be used in vessels that have diameters less than 5.5 mm as it may preclude safe placement of the 14f esheath optima introducer set' and 'use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set'.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.' the complaint for difficulty or inability to insert in-sheath dilator into sheath was unable to be confirmed as no device and/or relevant imagery were provided.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of the dhr did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As reported, 'during implant of a 23 mm sapien 3 ultra resilia valve in the aortic position, the surgeon used the 21f in-sheath dilator (isd) to predilate the sheath before putting in the commander delivery system.There was quite a bit of force while putting in the 21f isd.During the pre-dilation using the 21f the tip of the isd was able to progress past the iliac bifurcation in the abdominal aorta to the end of the sheath.When the physician removed the sheath at the end of the case, there was an iliac perforation.' per imagery review, undersized vessel and calcification were present in the patient's access vessels.Calcification can reduce the vessel lumen diameter and may increase restriction leading to difficulty during isd insertion.Calcification can also result in the creation of sub-optimal angles during isd insertion that may lead to resistance.Furthermore, undersized vessels can also create a restricted pathway or constrained condition resulting in difficulty during isd insertion.As such, available information suggests that patient factors (calcification, undersized vessel) may have contributed to the complaint event.Per the assessment, it has been determined that no capa, scar, or pra is required as the established triggers have not been met.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• 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: 22501107
• Report Number: 2015691-2025-05709
• Device Sequence Number: 6975028
• Product Code: DYB
• UDI-Device Identifier: 00690103220629
• UDI-Public: (01)00690103220629(17)251030(11)250501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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 Expiration Date: 10/30/2025
• Device Model Number: 14000ES14A
• Device Lot Number: 66598073
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 53 KG