MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH+ INTRODUCER SET; INTRODUCER, CATHETER

Model Number 916ESPA

Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 29 mm sapien 3 ultra resilia valve in the aortic position via transfemoral approach.When advancing the valve through the esheath valve passed semi expandable portion without issue however, when entering fully expandable portion, resistance was noted.Upon panning down to look at the area, the wire and distal part of the valve was outside the esheath.The system was removed, and new system was prepped.There was no patient complication.The access site had bleeding, but the operator believed it was due to closure device failure and not the sapien system.They ballooned the access site and gave protamine.There were no dissections or perforation noted.There was also no stenting or intervention needed for the patient's peripheral arteries.

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was not returned.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were unable to be confirmed as no returned product nor procedural imagery was provided.It is possible that one or more patient/procedural factors (access vessel calcification, tortuosity, undersized vessel diameters, and/or steep angle of insertion) may have been present during the procedure.However, due to insufficient information, a definitive root cause is unable to be determined.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Undersized vessels (e.G.Due to anatomical variation, pre-existing stent or graft, scar tissue, or fibrosis) can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion and increased resistance during the advancement of the delivery system.A steep insertion angle can result in non-coaxial alignment between the delivery system and sheath.Non-coaxial advancement of the delivery system through the sheath may lead to resistance.It is possible that additional device manipulation to overcome the resistance may be applied during the procedure resulting in damage to the sheath.During delivery system advancement through a challenging pathway, it is possible that the devices may not be coaxially aligned.This can lead to the crimped valve to catch onto the sheath hdpe, liner, and/or strain relief and lead to damage.Excessive device manipulation applied to overcome the resistance can further damage the sheath through continued interaction between the crimped valve and sheath.Vessel calcification and/or tortuosity if present can exasperate the interaction between the crimped valve and sheath.Sharp calcified nodules can directly weaken the sheath shaft making it more susceptible to damage as the delivery system with crimped valve is advanced through.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER SET
• 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: 18366438
• MDR Text Key: 331307520
• Report Number: 2015691-2023-18602
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)250726(11)2307272165198661
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 65198661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• 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