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

Model Number 9610ES14

Device Problem Peeled/Delaminated (1454)

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

Event Date 11/26/2021

Event Type  malfunction  

Event Description

As reported by the edwards (b)(6) affiliate, during a tavr case by left subclavian the 14f esheath was inserted without issue.Once the commander delivery system with 26mm sapien 3 ultra valve was inserted, the esheath kinked 90 degrees downward in the subclavian and the leading edge of the valve stent strut protruded through side of the sheath.The team was unable to advance or withdraw the delivery system into the sheath and the decision was made to remove the entire delivery system and sheath together while maintaining wire position.A new valve was prepped and new sheath advanced over the wire to just past the area of the vessel that caused the kink during the first attempt.The new delivery system inserted into the esheath to just before the 90 degree bend and stopped, the entire sheath/delivery system were slowly advanced forward around the bend and past the area of the previous kink without issue.Balloon alignment was performed in the ascending aorta out of the sheath and the procedure completed successfully with no injury or adverse outcome for the patient.Images were provided showing the area of the kink of the sheath, along with the torn liner and liner strand.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Corrected h.6 type of investigation, investigation findings, and component code.Added h.6 investigation conclusions.The device was not returned for evaluation.A dhr review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no complaints relating to these complaint events.During manufacturing of the esheath introducer set, 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.Imagery was provided of the sheath post procedure.A liner tear and liner strand were able to be identified.Scratches along the shaft near the distal end and a kink proximal to the crimped valve on the sheath shaft were identified.Edwards has provided guidelines and instructions to physicians on how to properly handle, prepare, and use the thv and system in the ifu and training materials.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.The users are instructed to correctly orient and lock the delivery system in default position before insertion and for the loader to be fully advanced into the sheath.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.If push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system.If push force is too high or valve and sheath are damaged or valve is still stuck, remove valve and sheath together as a single unit and replace, and do not over-manipulate the sheath at any time.In case of vascular injury, vascular complication management instructions are included for resolution.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.A product risk assessment (pra) was previously initiated to investigate the cause and assess the risks associated with high push force of the commander delivery system with sapien 3 ultra valve through the esheath.To address the issue, a corrective action preventative action (capa) was initiated to drive corrective actions.The valve from this complaint event was manufactured prior to the corrective action.The risks outlined in the pra remain the same.The pra documents the potential for difficulty or the inability to introduce delivery system/loader and advance through sheath, prolonging procedure, which did occur during this event.Trending analysis indicates complaint rates are within the november 2021 control limit for the trend category.The inability to advance the delivery system and valve through sheath, torn sheath liner, and sheath liner strand were confirmed through evaluation of the provided imagery.Without the return of the complaint device, engineering was unable to perform any visual, functional, and dimensional analysis.Thus, a manufacturing non-conformance could not be determined.However, review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per the description, 'once commander system with 26mm ultra inserted, esheath kinked in near 90 degree downward turn in subclavian and leading edge stent strut protruded through side of esheath'.Per the procedural training manual, 'push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification'.Scratches and a kink were identified from the imagery provided.Scratches are indicative of the device encountering calcification.Calcification can create a challenging pathway for the devices during advancement.A kink can be indicative of tortuosity encountered due to high bmi reported.The presence of tortuosity can create a challenging pathway for sheath insertion, as it can create suboptimal angles.If any potential excessive device manipulation or increased push force was applied to overcome the sheath insertion difficulty, the sheath shaft could then kink.A kinked sheath can then lead to resistance with delivery system insertion through the sheath, as the inner lumen of the sheath at the kinked location could be significantly smaller, disallowing the delivery system to be advanced.These patient factors, in conjunction with the exposed apices of the crimped s3u thv, may increase the rate of the thv getting caught on the sheath, preventing further advancement.A capa has identified potential areas for s3u design/process improvement to mitigate against the failure.As such, available information suggests that patient factors (calcification, tortuosity) procedural (steep insertion angle) may have contributed to the complaint event.Per evaluation of the provided imagery, the sheath liner had a tear and a strand.Scratches were observed on sheath which are indicative of the sheath encountering calcification.Calcified vessels may have interacted with the sheath liner, weakening, or directly tearing it.Additionally, the crimped valve inserted at a steep angle can create non-coaxial interaction within the sheath inner lumen leading to a strut potentially catching onto the liner and tearing it if excessive device manipulation was used.As such, available information suggests that patient factors (calcification) and procedural factors (valve caught on liner, excessive manipulation) may have contributed to the complaint event.

• Brand Name: EDWARDS EXPANDABLE 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: 13031011
• MDR Text Key: 285639610
• Report Number: 2015691-2021-06909
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103191219
• UDI-Public: (01)00690103191219(17)230413(10)63742868
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Model Number: 9610ES14
• Device Lot Number: 63742868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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 Age: 72 YR
• Patient Sex: Male