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

Model Number 914ESPA

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

During the implantation of a 23mm sapien 3 ultra valve in the aortic position there was difficulty advancing the valve through the tip of the sheath.It went through with a more forceful push.Upon removal, the sheath tip had torn, though appear to be present.Sheath kept for return.I assume the crimped valve caught on the tip of the sheath causing the tear.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.The device was not returned for evaluation and no image was provided to perform an image review.As the device was not returned, engineering was unable to perform any visual inspection, dimensional analysis, or functional testing.During manufacturing all inspections are conducted on 100% of the units.The entire device is visually inspected and dimensionally testing during the manufacturing process.A device history record (dhr) 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 no related complaints were found except "introduce and navigate system through sheath and "inability to advance through sheath." a manufacturing mitigation review was performed and the inspections and tests support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.The ifu provides guidance for precautions and valve delivery.Precautions: caution should be used in vessels that have diameters less than 5.5 mm or 6 mm as it may preclude safe placement of the 14f and 16f edwards esheath plus introducer set respectively.Use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set.Do not use the edwards esheath plus introducer set if the packaging sterile barriers and any components have been opened or damaged.When inserting, manipulating, or withdrawing a device through the sheath, always maintain sheath position.When puncturing, suturing, or incising the tissue near the sheath, use caution to avoid damage to the sheath.Expansion tool does not contain a hydrophilic coating.Do not use as a dilator.If a significant increase in resistance occurs when advancing the catheter through the vasculature, stop advancement and investigate the cause of resistance before proceeding.Do not force passage, as this could increase the risk of vascular complications.Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: access characteristics that would preclude safe placement of the edwards sheath, such as severe obstructive calcification or severe tortuosity.Valve delivery: gain access using standard catheterization techniques.Prepare and insert the edwards sheath.Refer to the edwards sheath ifu for information on device preparation and handling.Insert the loader into the sheath until the loader stops.Advance the edwards commander delivery system, with the edwards logo in the proper orientation (the delivery system articulates in a direction opposite from the flush port), through the sheath until the valve exits the sheath.Note: maintain the proper orientation of the flex catheter throughout the procedure.The delivery system articulates in a direction opposite from the flush port.Caution: for iliofemoral access, the valve should not be advanced through the sheath if the sheath tip is not past the bifurcation.The procedural training manual provides guidance for sheath insertion and delivery system insertion through sheath.Sheath insertion: the proximal tapered end of the sheath is larger in diameter.Hydrate sheath but do not wipe off hydrophilic coating.Insert the sheath with the edwards logo facing upward so the seam remains down to ensure proper sheath performance.Ensure the sheath and introducer remain locked together at the hub during insertion.Insert slowly with continuous motion to minimize friction.Ensure fully expandable portion remains completely within the vessel for proper hemostasis.Ensure the sheath tip is inserted past the aortic bifurcation (above the renal arteries).Note: do not use if the sheath has surface defects or damage.Note: the sheath is pre-expanded during the device prep process and a slightly raised seam may be visible.This can be pressed down as needed to ensure a smooth insertion.Note: slight wrinkling in the partially expandable section may be observed during insertion.Note: do not flush sheath with introducer or delivery system inserted.Additional considerations: heparin should be given prior to sheath placement to ensure act greater than or equal to 250 seconds, use stiff wire (for peripheral access only) in case of peripheral tortuosity, use wires such as supracore or lunderquist (cook), apply tension to wire to provide firm rail for placement, always observe fluoroscopy during insertion.Know position of sheath tip in the aorta, proper screening is critical to reducing vascular complications, push force can vary due to angle of access and insertion, vessel diameter, tortuosity, and degree of calcification.Perform shallow stick/puncture so that the sheath is parallel to leg, do not over-manipulate the sheath at any time.Once inserted, unlock the introducer by rotating the introducer hub counterclockwise.Once unlocked, remove the introducer from the sheath.Suture sheath in place.Additional considerations: do not force sheath.If having trouble inserting sheath, remove the sheath and try pre-dilating the vessel with a dilator or making the incision larger.Check to ensure sheath is not damaged before reinserting.If damaged, return and replace with a new sheath, perform contrast injection if: angulated aorta, aneurysms, significant aortic atherosclerosis, if a kink is visible in the sheath after the introducer is removed reinsert the introducer into the sheath, exchange to a stiff wire (if not already done) and replace with a new sheath and slide the 68-system advancement force with best practices.The following best practices may be considered for a thv procedure at the physician's discretion.Additional considerations should be made for the presence of tortuous anatomy, small vessel diameters and/or calcification.Crimp technique verification - utilize proper crimp technique by performing 3x crimp for 5 seconds every time.This ensures the appropriate crimp profile for the valve to be inserted through the sheath without adding to system advancement force.Vessel dilation prior to sheath insertion - an additional dilator is included with the system for vessel dilation as needed.Utilization of a stiff wire for initial sheath insertion, then switched out with a standard wire - use of a stiff wire (for peripheral access only) can be used in cases with peripheral tortuosity (for example, supracore or lunderquist).This method may be utilized for straightening the vessel anatomy for access, but not for valve crossing.Sheath seam orientation - insert the sheath with the edwards logo facing upward so the seam remains down to ensure proper sheath performance.Sheath insertion angle and short movements - system advancement force can vary due to angle of access and insertion, vessel diameter, tortuosity, and degree of calcification.Perform shallow stick/puncture so that sheath is parallel to leg.Use short movements and push delivery system closer to sheath hub.Imaging confirmation - if system advancement force is too high or valve is initially stuck, zoom in and rotate the c-arm to ensure valve and sheath are not damaged.Delivery system insertion through sheath: correctly orient delivery system and check position before insertion.Orient the delivery system with the flush port pointing away and the edwards logo facing up.Ensure delivery system is locked in default position.Note: aspirate as necessary during delivery system insertion.Note: take care when handling.Do not bend system at the handle or tip.Note: maintain edwards logo up throughout the procedure to prevent kinking of the delivery system.If working length is insufficient, peel away the loader tube and remove while maintaining delivery system and wire position.Insertion force through the partially expandable portion can be higher that the push force through the fully expandable portion.In expectation of high friction, use short movements and push delivery system closer to sheath hub.Note: in expectation of high friction, use short movements.Push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification.Following proper valve crimping technique and ensure valve is delivered as straight as possible.Be careful to not bend the proximal end of the sheath when inserting the delivery system through the sheath.If push force is too high or valve is initially stuck, zoom in the rotate the c-arm to ensure valve and sheath are not damaged.If damaged, retract valve in sheath slightly.Remove valve and sheath together as single unit and replace.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 is still stuck, remove valve and sheath together as single unit and replace.Do not over-manipulate the sheath at any time.Check delivery system is locked in default position and edwards logo up.Insert loader completely into sheath until it stops.Ensure wire is still in left ventricle (lv).Ensure sheath tip is still past the aortic bifurcation (above the renal arteries).Advance thv through loader and sheath using short movements.Retract loader and peel away (if needed).Caution: the thv should not be advanced through the sheath if the sheath tip is not past the aortic bifurcation.Caution: to prevent possible leaflet damage, the thv should not remain in the sheath for over 5 minutes.No ifu/training deficiencies were identified.A complaint history review is not required as the complaints for "sheath distal tip torn" and "difficulty advancing through sheath" were unable to be confirmed.A risk management documentation review was performed and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.Current risk mitigations include design and manufacturing controls, ifu warnings and cautions, and physician training on how to insert delivery system into sheath.The benefits of the device outweigh the risks associated with the inability to introduce delivery system and advance through sheath, prolonging procedure.The complaints for "sheath distal tip torn" and "difficulty advancing through sheath" was unable to be confirmed as there was no returned device or applicable imagery.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.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, no abnormalities were noted during device unpacking or preparation.Per the complaint description, "there was difficulty advancing the valve through the tip of the sheath.It went through with a more forceful push.Upon removal, the sheath tip had torn though appear to be present".The failure mode described is characteristic of sheath tip tear events identified in a product risk assessment (pra).While a definitive root cause was unable to be determined, investigation documented in the pra indicates that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the experienced delivery system advancement resistance at the sheath distal tip and the distal tip tear.However, a definitive root cause is unable to be determined at this time.

• Brand Name: ESHEATH PLUS INTRODUCER SHEATH
• 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: 13416717
• MDR Text Key: 285054748
• Report Number: 2015691-2022-03737
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)230930(11)2109302164005199
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64005199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2023
• 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 Sex: Female