MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ESHEATH PLUS INTRODUCER SHEATH; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 914ESPA

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

As reported by the field clinical specialist, during a tf tavr with a 26mm sapien 3 ultra valve in the aortic position, upon the first attempt to insert the esheath it would not advance with significant force.The sheath was then removed to pre dilate the vessel, and when examined, it was found the sheath had split on a part that was not supposed to.The decision was made to open a new sheath for insertion that went in without complication.There were no complications or vascular damage due to sheath failure.Per the field clinical specialist, the split was at the distal tip.

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.Sections g6, h2, h6: component code, type of investigation, investigation findings, investigation conclusions and h10 has been updated.The esheath+ was returned to edwards lifesciences.Images were provided and the following observed relevant to the complaint event: 5: 3mensio report of the patient's anatomy showed that the access vessel size was appropriate for use of the 14f esheath+ (greater than or equal to 5.5mm), with calcification and tortuosity present in the access vessels.An image of the device post-procedure showed that the distal tip was partially opened along the axial score line only.A visual inspection was performed on the returned esheath plus and the following was observed: some curvature was present on the esheath+ shaft.The liner was unexpanded.The tip was partially opened only along axial score line, with stretching noted at distal tip, proximal to the partially opened tip.There was a scratch on the high-density polyethylene (hdpe), near the distal tip.Due to the nature of the complaint, a functional testing was unable to be performed.A dimensional inspection was unable to be performed due to the condition of the returned device.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 this adverse event is not required at this time.It was reported that "upon the first attempt to insert the esheath it would not advance despite significant force.The esheath+ was then removed to pre dilate the vessel, and when examined, it was found the esheath+ had split on a part that it was not supposed to".However, upon engineering evaluation of the returned device it was clarified that there was no vertical split on the distal tip.Rather, the reported "split" was referring to the distal tip prematurely opening along the axial score line, with a some stretching noted on the hdpe proximal to this area.If the open tip creates an uneven transition between the introducer and the esheath+, it may result in difficulty placing the esheath+ in the vessel and may need to be exchanged with another device.This can be done over the guide wire with minimal risk to the patient.There was no manufacturing non-conformance identified on the returned device.Reviews of the device history records, complaint history, and lot history showed no indication a manufacturing non-conformance contributed to the event.A review of the instructions for use (ifu) and training manuals was performed, and no deficiencies were identified.Furthermore, there were no abnormalities noted during device preparation.Per the training manual, "push force can vary due to angle of access and insertion, vessel diameter, tortuosity and degree of calcification".In this case, the presence of calcification and tortuosity in the access vessel was evidenced by the images reviewed.Additionally, the scratch observed on the hdpe near the distal tip is indicative of the device interaction with calcification.Tortuosity induces sub-optimal angles for esheath+ insertion influencing the shaft to bend and requiring a high push force to navigate.Calcification can create added friction on the outer shaft.If "significant force" was used in attempts to overcome the resistance induced by calcification, the distal tip can become damaged and prematurely open along the axial score line.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (high push force) may have contributed to the events.However, a definite root cause could not be determined at this time.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.Therefore, no corrective action nor product risk assessment is required at this time.Based on the engineering evaluation this event is no longer fda reportable and the initial report submitted is herein retracted.Upon further review of this case, it was noted that field b2: required intervention to prevent permanent impairment/damage (devices) was incorrectly selected on the initial report for this case.B2 should be blank and the previous entry disregarded.

• Brand Name: ESHEATH PLUS INTRODUCER SHEATH
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: 15085491
• MDR Text Key: 301942735
• Report Number: 2015691-2022-06962
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240420(11)2204212164341591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64341591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Female