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

Model Number 9610ES14

Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2023

Event Type  malfunction  

Event Description

As reported by an edwards canada affiliate, during a right transfemoral tavr procedure with a 26mm sapien 3 ultra valve, resistance was felt while attempting to advance the valve through the esheath at the iliac, so the team attempted to retract the delivery system to change the angle of approach.However, the commander delivery system balloon started to align on the valve, and resistance was felt on the system, so retraction of the system was stopped.Fluoro imaging showed the esheath appeared to have split, and the distal end of the valve and the proximal end of the pusher were outside of the esheath.The commander delivery system and valve were removed as one unit with some difficulties due to the esheath being split.The patient was noted to have a vascular injury requiring 3 iliac stents and was sent to icu without receiving the tavr valve.While in icu, the patient had stenosed iliac stents, so was sent for an emergency fem-fem bypass.The patient is currently recovering in stable condition in icu.Per report, the patient had a tortuous and calcified vascular anatomy.Per device images provided, an esheath liner strand was observed.

Manufacturer Narrative

This is one of 2 reports being submitted for this reported event.The mentioned injury will be captured under the 26mm sapien 3 ultra valve.The investigation is still ongoing.

Manufacturer Narrative

Correction to h6 based on additional evaluation.The device was returned to edwards lifesciences for evaluation.The returned device was visually examined, and the following was observed: the esheath shaft was slightly curved.The liner was torn approximately 12 cm from the strain relief.The distal tip was unopened, and a liner strand was noted 1 cm from strain relief.The liner was partially delaminated 2 cm in length at approximately 7 cm from the strain relief.The esheath shaft was damage 11 cm from the strain relief where the crimped valve was located.Dimensional testing was performed on the returned device, and all measurements were found to be within the specification.Images were provided by the site, and the following was observed: procedural image of the valve not aligned between the markers.The commander delivery system with the crimped valve appears to be exiting through the punctured esheath liner.Post-procedural image shows the esheath inserted through commander delivery system.The liner appears to be torn at the proximal part of the sheath shaft.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 complaint for inability to advance through the esheath was confirmed based on provided picture and returned device.Available information suggests patient factors (calcification, tortuosity) likely contributed to the event as calcification and tortuosity was reported in the patient's access vessel.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.Additionally, 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.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.The complaint for liner punctured and esheath liner strand were confirmed based on returned device and provided images.Available information suggests patient (calcification, tortuosity) and procedural (excessive manipulation) factors likely contributed to the event as calcification and tortuosity was reported in the patient's access vessel.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.

• 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: 18251906
• MDR Text Key: 330020026
• Report Number: 2015691-2023-17862
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Lot Number: 65165378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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 Age: 85 YR
• Patient Sex: Male