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

Model Number 916ESPA

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

Patient Problem Vascular Dissection (3160)

Event Date 01/25/2024

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 29mm sapien 3 valve in the aortic position, 16f esheath plus became damaged during insertion into this diseased anatomy.This patient had a large amount of disease in the peripheral arteries.There was difficulty advancing the sheath.Once the sheath was in place, the team attempted to insert the valve and delivery system into the sheath.The team was unable to advance the delivery system through the sheath.The case was aborted.Per additional information from the fcs, the initial reporter did not allege the edwards devices were deficient in any way.The fcs confirmed only one sheath was damaged during the procedure.The damage to the sheath was seam separation at the tip of the esheath.Per the fcs, there was a small dissection/perforation that occurred in the common femoral (insertion point) that was repaired surgically.The expansion tool was used, the loader was able to be fully inserted into the sheath/sheathing housing.The sheath was not inserted at a steep angle.The delivery system was at the partially expandable portion of the sheath when resistance was observed.

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was discarded.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The complaints for difficulty introducing sheath and sheath distal tip split and subsequent vascular dissection were unable to be confirmed without the returned device or relevant procedural imagery.A review of the dhr and lot history 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, there was no report of any issues with the sheath during device unpacking or preparation.As device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.As reported, ''during a tavr procedure with a 29mm sapien 3 valve in the aortic position, multiple 16f esheath plus's were required because the sheath became damaged during insertion into this diseased anatomy.This patient had a large amount of disease in the peripheral arteries.There was difficulty advancing the sheath.Once the sheath was in place, the team attempted to insert the valve and delivery system into the sheath.The team was unable to advance the delivery system through the sheath''.Per imaging evaluation, calcification and tortuosity were present in the access vessels and undersized vessel regions (greater than or equal to 6.0mm is indicated for 16f sheaths).Per the training manual, ''push force can vary due to angle of insertion, thv size vessel diameter, tortuosity and degree of calcification'' during sheath insertion and during delivery system advancement through the sheath.Calcification can reduce the vessel lumen diameter and may increase restriction impacting trackability of devices within the vessel.Undersized vessels can exasperate this restricted pathway resulting in further difficulty.Lastly, tortuosity can subject the sheath to sub-optimal angles that can increase resistance during insertion.If excessive manipulation was applied to overcome the resistance experienced introducing the sheath along and/or during delivery system insertion, this may cause the sheath distal tip to interact with sharp nodules of calcification, resulting in damage to the tip (reportedly a split).Available information suggests that patient factors (tortuosity, calcification, undersized vessel) and procedural factor (excessive manipulation) may have contributed to the reported event.However, a definitive root cause is unable to be determined at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 PLUS INTRODUCER SHEATH SET
• 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: 18778490
• MDR Text Key: 336221468
• Report Number: 2015691-2024-01318
• Device Sequence Number: 1
• Product Code: DYB
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Device Lot Number: 65443462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male