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

Model Number 916ESPA

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 29mm sapien 3 valve in the aortic position, as the team inserted valve into the sheath, there was buckling of the wire so they panned down to the sheath and saw the system and valve was also buckling and the valve was outside of the sheath.The seam on the sheath must have completely torn before they put the valve in and after we passed an 18 fr dilator through it.There was no difficulty inserting the sheath into the patient, but there was difficulty inserting the delivery system though the sheath.The fcs advised that is was because the wire and system were bowing due to the seam being torn and the valve was outside on the sheath.Access was achieved on the right side.The delivery system was completely unflexed and deflated.It was positioned in the default position prior to removal.There was no difficulty retrieving the device through the sheath tip.The valve was crimpled properly per the ifu/training manual.The team had to open a new sheath, valve and delivery system.The fcs clarified that the part of the procedure where the liner tore was when they inserted the 18 dilator into the sheath.

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings, type of investigation, investigation findings, investigation conclusions and h10 has been added.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.An imagery evaluation was conducted, and the patient's right access vessel had presence of tortuosity and calcification.The complaints for liner punctured, resistance between system components and inability to advance through sheath were unable to be confirmed as no device was returned nor relevant procedural imagery provided.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.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 reported, 'during a tavr procedure with a 29mm sapien 3 valve in the aortic position, as the team inserted valve into the sheath, there was buckling of the wire, so they panned down to the sheath and saw the system and valve was also buckling and the valve was outside of the sheath.The seam on the sheath must have completely torn before they put the valve in and after we passed an 18 fr dilator through the fcs clarified that the part of the procedure where the liner tore was when they inserted the 18 dilator into the sheath.' per imagery review, calcification and tortuosity were present in the patient's right access vessel.Per the ifu, 'insert the introducer completely into the sheath and turn clockwise to lock the introducer hub to the sheath hub.Using standard catheterization techniques, gain access to the vessel and dilate as necessary with the dilator to accommodate the sheath.' the 18f dilator is to be used for vessel dilation prior to sheath insertion.It is possible that the liner became exposed as the 18f dilator was inserted through the sheath.Calcification can damage the exposed portion of the sheath liner.Damage along the liner could lead to immediate cutting/tearing or could weaken the liner.A weakened liner can tear during insertion and/or removal of devices through the sheath.Vessel angulation can create suboptimal angles during device insertion through the sheath and exasperate the interaction between the devices and the liner, which may further contribute to the liner puncture.However, it is unknown when the liner tore during the procedure.As such, available information suggests that patient factors (calcification, tortuosity) and/or use error (failure to follow instructions) may have contributed to the complaint event.Resistance may be experienced during delivery system advancement if the delivery system and valve are protruding through the liner puncture as this will prevent coaxial alignment of the devices through the sheath.As such, available information suggests that procedural factors (liner puncture) may have contributed to the complaint event.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18908784
• MDR Text Key: 337768133
• Report Number: 2015691-2024-02017
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)250823(11)230824
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Device Lot Number: 65266383
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2023
• 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: Male