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

Model Number 916ESPA

Device Problem Material Puncture/Hole (1504)

Patient Problem Vascular Dissection (3160)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.H3 other text : not returned for evaluation.

Event Description

As reported by the field clinical specialist, during a transfemoral tavr procedure, the 29 mm sapien 3 ultra resilia valve exited the side (near the middle of the expandable seam) of the 16f esheath in the right external iliac area.There was no resistance felt during advancing the valve into the esheath, the resistance was noted halfway through the sheath shaft.The entire system was removed as one (valve/delivery system/esheath) while maintaining the wire.The esheath was not damaged.A new 16 f esheath was placed, and a 29 mm sapien 3 ultra resilia valve was mounted on the new 26 mm commander delivery system.The valve was placed in the aortic position without any issues.The patient experienced a right common femoral dissection, and a cutdown was used to fix the dissection.No additional patient complications were reported.

Manufacturer Narrative

A supplemental report is being submitted for the completed engineering evaluation.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.The instructions for use (ifu), current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint for liner punctured was unable to be confirmed as no device/relevant procedural imagery were returned.Therefore, the presence of a manufacturing non-conformance was unable to be determined.As reported, ''the 29 mm sapien 3 ultra resilia valve exited the side of the 16f esheath in the right external iliac area.'' per imagery review, tortuosity and calcification were present in the patient's right access vessel and the patient reportedly had moderate tortuosity and low calcification in the access vessel.Tortuous and calcified patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with a crimped valve and sheath inner lumen, leading to increased interaction between the valve and the sheath.This can lead to the crimped valve catching onto the sheath liner and lead to damage.Per the engineering summary, no manufacturing nonconformances that would have contributed to the complaint event were identified.Available information suggests that patient factors (tortuosity, calcification) and/or procedural factors (valve caught on liner) may have contributed to the complaint event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation is required.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18377167
• MDR Text Key: 331179239
• Report Number: 2015691-2023-18674
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)250426(11)2304272165287834
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male