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

Model Number 914ESPA

Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

As reported, during a procedure to implant a 26mm sapien 3 ultra valve in the aortic position, via transfemoral approach, as the valve and delivery system were being advanced through the esheath, the valve punctured through the esheath at the expandable portion of the sheath.Once the valve exited the esheath, it advanced into an aneurysm that was in the abdominal aorta.The patient had narrow right common iliac artery, so the resistance was slightly higher than usual.A stiffer wire was used which allowed for the commander system and sheath to straighten enough to then retract the valve back into the sheath and remove the entire system (valve, delivery, and sheath) together.There was no vascular injury reported.There was damage noted to the esheath as the delivery system and valve punctured through the expandable portion of the esheath.A new esheath, delivery system and valve were used with success.This time, they used a stiff wire to slowly advance the system through the sheath.The patient remained stable.

Manufacturer Narrative

Investigation is ongoing.Device expected back.

Manufacturer Narrative

As the device was not returned for evaluation, no visual inspection, functional testing and dimensioning testing could be performed.No imagery was returned for review.A device history record (dhr) review was performed related to the manufacturing of the devices and components that could potentially contribute to the complaint and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review of the work order was performed and revealed no other complaints relating to the complaint codes below.During manufacturing of the esheath+, the sheath and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The instructions for use (ifu)/training mitigations/controls relevant to the reported issue (difficulty advancing the commander delivery system with s3u crimped valve through the esheath resulting in a high push force and esheath damage) is captured in a product risk assessment (pra).Although the pra captures ifu/training mitigations/controls specific to the esheath, the pra remains applicable for high push force events using the esheath+ device.The users are instructed on how to screen patients to ensure adequate vessel access and to reduce vascular complications.In addition, a step-by-step instruction on how to insert and advance a delivery system through the sheath including mitigation steps and best practices to address high push force are provided.Insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion, and in expectation of high friction, use short movements and push delivery system closer to sheath hub.Push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity, and degree of calcification.Based on the review, no ifu or training deficiencies were identified.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.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 events were unable to be confirmed without the returned device or procedural imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, 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 manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.Per complaint details, ''as the valve and delivery system were being advanced through the esheath, it punctured through the esheath at the expandable portion of the sheath.Once the valve exited the esheath, it went out and into an aneurysm that was in the abdominal aorta located right above the bifurcation of the common iliac artery''.Per the ifu/training manual, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification''.Additional information stated that there was stenosis and tortuosity present within the access vessels.Tortuosity and stenosis can create a challenging pathway for sheath insertion and can lead to non-axial alignment in the advancement of the delivery system through the sheath.Additionally, if excessive manipulation was used in an attempt to overcome the experienced resistance, it's possible that it could have caused the valve to puncture the liner during advancement.As such, available information suggests that patient (tortuosity, stenosis) and procedural factors (excessive manipulation) may have contributed to the complaint event.A pra was previously initiated to investigate the cause and assess the risks associated with high push force of the commander delivery system with s3u through the esheath.This pra continues to apply to esheath+ as there are no significant changes related to the sheath shaft.The only update is related to the strain relief material at the proximal end of the sheath shaft.This was modified to improve manufacturability at the component level for improvements relating to extrusion and handling and does not affect system advancement through the sheath.Since no product non-conformances or ifu/training manual deficiencies were identified, no escalation to a pra was required related to the liner puncture.As no edwards defect that could have resulted in the complaint was identified, no preventative or corrective actions (capa) are required.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 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 PLUS
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWWARDS 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: 14650686
• MDR Text Key: 301036086
• Report Number: 2015691-2022-06128
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)230929(11)2109292164005197
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2023
• Device Model Number: 914ESPA
• Device Lot Number: 64005197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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 Sex: Male