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

Model Number 914ESPA

Device Problems Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure with a 23mm sapien 3 ultra valve, the commander delivery system and valve was getting caught at the common femoral artery, possibly at tract, during insertion within the esheath+.The operators dilated the tract with spreaders.The delivery system still would not advance after multiple attempts, so the devices were removed as a unit.During inspection of the removed devices, the 14fr esheath+ appeared to be torn at the level of the crimped valve.A new system was prepped and used.The valve was successfully implanted.There was no injury to the patient.Per images received, the strain relief was damaged, and a liner strand was observed.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.However, fluoro imaging was provided by the site and device.The following was observed: procedural fluoro imagery shows the crimped valve and delivery system appearing within the sheath shaft at a bend in the access vessel, near the femoral head.Post procedural device imagery shows sheath shaft curvature, a liner tear with the crimped valve exposed through it, a liner strand, and strain relief damage.The 3mensio imaging report for the patient was provided and shows a tortuous access vessel with calcification present in the abdominal aorta.However, the calcification was unlikely a contributing factor due to location of the resistance.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The reported events were confirmed through provided imaging from the site.Available information suggests patient factors (tortuosity) and/or procedural factors (steep insertion angle) likely contributed to the resistance experienced inserting the delivery system through the sheath.Tortuous patient anatomy can create sub-optimal angles that can lead to non coaxial alignment between the delivery system with crimped valve and sheath inner lumen.A steep insertion angle can result in non coaxial alignment between the delivery system and sheath.Non coaxial advancement of the delivery system through the sheath may lead to resistance.It is possible that additional device manipulation to overcome the resistance may be applied during the procedure resulting in damage to the sheath.During delivery system advancement through a challenging pathway, it is possible that the devices may not be coaxially aligned.This can lead to the crimped valve to catch onto the sheath hdpe, liner, and/or strain relief and lead to damage.Excessive device manipulation applied to overcome the resistance can further damage the sheath through continued interaction between the crimped valve and sheath.Vessel tortuosity if present can exasperate the interaction between the crimped valve and sheath resulting in the damaged liner and strain relief.Therefore, available information suggests patient factors (tortuosity) and/or procedural factors (excessive manipulation, valve interaction with liner and strain relief) likely contributed to the sheath damages.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER
• Type of Device: 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: 18191986
• MDR Text Key: 328807179
• Report Number: 2015691-2023-17686
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)250508(11)230509
• 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
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Lot Number: 65043112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1